No full-text available
To read the full-text of this research,
you can request a copy directly from the authors.
Acupuncture for Chronic Low Back Pain A Multicenter, Randomized, Patient-Assessor Blind, Sham-Controlled Clinical Trial
Abstract
Study design:
Multicenter, randomized, patient-assessor blind, sham-controlled clinical trial.
Objective:
To investigate the efficacy of acupuncture treatment with individualized setting for reduction of bothersomeness in participants with chronic low back pain (cLBP).
Summary of background data:
Low back pain is one of the main reasons of disability among adults of working age. Acupuncture is known as an effective treatment of cLBP, but it remains unclear whether acupuncture is superior to placebo.
Methods:
One hundred thirty adults aged 18 to 65 years with nonspecific LBP lasting for at least last 3 months prior to the trial participated in the study from 3 Korean medical hospitals. Participants received individualized real acupuncture treatments or sham acupuncture treatments for more than 6 weeks (twice a week) from Korean Medicine doctors. Primary outcome was change of visual analogue scale (VAS) score for bothersomeness of cLBP. Secondary outcomes included VAS score for pain intensity and questionnaires including Oswestry Disability Index, general health status (Short Form-36), and Beck Depression Inventory (BDI).
Results:
There were no baseline differences observed between the 2 groups, except in the Oswestry Disability Index. One hundred sixteen participants finished the treatments and 3- and 6-month follow-ups, with 14 subjects dropping out. Significant difference in VAS score for bothersomeness and pain intensity score of cLBP has been found between the 2 groups (P < 0.05) at the primary end point (8 wk). In addition, those 2 scores improved continuously until 3-month follow-up (P = 0.011, P = 0.005, respectively). Oswestry Disability Index, the Beck Depression Inventory, and Short Form-36 scores were also improved in both groups without group difference.
Conclusion:
This randomized sham-controlled trial suggests that acupuncture treatment shows better effect on the reduction of the bothersomeness and pain intensity than sham control in participants with cLBP.
... Three trials 31,38,39 were classified as high risk owing to inadequate random sequence generation, such as including different groups based on the treatment approach, baseline balance, and patient wishes. Twelve trials 8,29,40,43,46,[49][50][51][52][53][54][55] were classified as high risk because they did not use the correct blinding method. Four trials 8,40,43,55 were classified as high risk owing to incomplete outcome data because of high patient attrition or inconsistencies in the amount of attrition between groups. ...
... Twelve trials 8,29,40,43,46,[49][50][51][52][53][54][55] were classified as high risk because they did not use the correct blinding method. Four trials 8,40,43,55 were classified as high risk owing to incomplete outcome data because of high patient attrition or inconsistencies in the amount of attrition between groups. Regarding other bias, only one study 51 was rated as having a high risk of bias owing to a baseline imbalance. ...
... Regarding other bias, only one study 51 was rated as having a high risk of bias owing to a baseline imbalance. Briefly, approximately 16.67% of the studies 8,40,43,51,55 were classified as having a high risk of overall bias. ...
Background:
Nonspecific low back pain (NLBP) is a common disabling disease that cannot be attributed to a specific, recognizable pathology. The use of acupuncture for NLBP is supported by several guidelines and systematic reviews. However, the efficacy of different acupuncture methods for NLBP management is still debated. This study ranked the effectiveness of acupuncture methods using network meta-analysis to screen out the optimal acupuncture methods and expound the current controversies for their effective application in health policies as well as guiding clinical operations.
Methods:
The following databases were searched for relevant randomized controlled trials (RCTs) from inception to December 20, 2020: China National Knowledge Infrastructure, VIP Database for Chinese Technical Periodicals, WANFANG Database, Chinese biomedical literature service system, PubMed, Web of Science, Embase, and Cochrane Library. Relevant registration platforms, including the International Standard Randomised Controlled Trial Number Register (ISRCTN) and Chinese Clinical Trial Registry (ChiCTR), were also searched. Manual retrieval and tracking of references was also performed. Pairwise meta-analysis and Bayesian network meta-analysis using Revman and ADDIS, respectively, were performed and standardized mean differences examined. The primary outcome was visual analog scale (VAS) score and the secondary outcome was Oswestry Disability Index (ODI) score. Safety was defined as the incidence of adverse events.
Results:
A total of 30 trials with 3196 participants were analyzed; 16.67% of which showed a high risk of bias. The results indicated that fire acupuncture plus manual acupuncture, auricular needling, and electroacupuncture plus warm acupuncture were most effective in reducing VAS score. The most effective interventions for reducing ODI score were manual acupuncture plus conventional medicines, followed by moxibustion and manual acupuncture plus moxibustion. Manual acupuncture plus moxibustion was dominant in the cluster ranking. Acupuncture showed a lower incidence of adverse events (7.70%) than other interventions (conventional medicines, routine care, and placebo; 12.24%).
Conclusion:
We found that manual acupuncture plus moxibustion is the most effective way to reduce NLBP pain and disability. Acupuncture is safer than other interventions. However, more direct comparative evidence from high-quality, large-sample, multicenter RCTs is needed to validate these findings.
... However, 224 records are not randomized clinical trials, 38 records are lacking outcomes, 23 records have incorrect study design, 14 records contain inappropriate interventions, and 4 records are case reports. In total, 24 RCTs were included in the systematic review, 22 records were included in the metaanalysis, [17][18][19][20][21][22][23][24][25][26][27][28][29][30][33][34][35][36][37][38][39][40] but the other 2 records did not provide complete data or relevant outcomes and were excluded. 31,32 Study Characteristics A descriptive summary of the studies included in the review is shown in Tables 1 and 2. Sixteen records involved standard acupuncture with needle stimulation, 5 records involved laser/ electro-acupuncture, 2 records involved auricular acupuncture, and 1 record involved bee venom acupuncture. ...
... I 2 0%, high-quality evidence, including 3 studies and 196 patients) in the immediate-term ( Figure 3A, including 20 studies and 1931 patients). [17][18][19][20][21][22][23][24][26][27][28][32][33][34][35][36][37][38][39][40] For short-term outcomes, acupuncture had a significant effect on the reduction in chronic low back pain (WMD À9.31, 95% CI À14.32 to À4.31, I 2 83.1%, moderate-quality evidence, including 4 studies and 319 patients) and pain from sciatica (WMD À8.90, 95% CI À17.28 to À0.52, ...
... I 2 93.0%, moderate-quality evidence, including 2 studies and 146 patients; Figure 3C, including 7 studies and 639 patients). 17,21,25,27,29,34,35 In the long-term, acupuncture, compared to the control treatments, had only a modest effect on the reduction in chronic neck pain (WMD À4.91, 95% CI À13.37 to 3.54, I 2 57.5%, low-quality evidence, including 2 studies and 190 patients) and chronic low back pain (WMD À8.28, 95% CI À9.84 to À6.72, I 2 0%, high-quality evidence, including 2 studies and 296 patients) and a significant effect on sciatica treatment (WMD À17.60, 95% CI À19.23 to À15.97, ...
Study design:
Systematic review and meta-analysis.
Objective:
To investigate the effect and safety of acupuncture for the treatment of chronic spinal pain.
Methods:
MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, the WHO Clinical Trial Registry, and the US National Library of Medicine clinical trial registry were searched from January 1, 2000, to November 1, 2019. Randomized controlled trials (RCTs) involving patients with chronic spinal pain treated by acupuncture versus sham acupuncture, no treatment, or another treatment were included.
Results:
Data was extracted from 22 RCTs including 2588 patients. Pooled analysis revealed that acupuncture can reduce chronic spinal pain compared to sham acupuncture (weighted mean difference [WMD] -12.05, 95% confidence interval [CI] -15.86 to -8.24), mediation control (WMD -18.27, 95% CI -28.18 to -8.37), usual care control (WMD -9.57, 95% CI -13.48 to -9.44), and no treatment control (WMD -17.10, 95% CI -24.83 to -9.37). In terms of functional disability, acupuncture can improve physical function at immediate-term follow-up (standardized mean difference [SMD] -1.74, 95% CI -2.04 to -1.44), short-term follow-up (SMD -0.89, 95% CI -1.15 to -0.62), and long-term follow-up (SMD -1.25, 95% CI -1.48 to -1.03).
Conclusion:
In summary, compared to no treatment, sham acupuncture, or conventional therapy such as medication, massage, and physical exercise, acupuncture has a significantly superior effect on the reduction in chronic spinal pain and function improvement. Acupuncture might be an effective treatment for patients with chronic spinal pain and it is a safe therapy.
... 5 With respect to its efficacy, some randomised controlled clinical trials (RCTs) of acupuncture have demonstrated that acupuncture is not more effective than sham or placebo acupuncture. [6][7][8] The Cochrane review 9 and other systematic reviews (SRs) and studies [10][11][12][13] have reached different conclusions for NSLBP. One SR in 2017 demonstrated that non-traditional needling (one type of sham acupuncture) may be effective in patients with LBP secondary to myofascial pain syndrome. ...
... In total, we included 14 trials (2110 participants): four trials included participants with (sub)acute NSLBP 6,8,15,16 and 10 trials included participants with chronic NSLBP. 7,[17][18][19][20][21][22][23][24][25] Details of each trial are provided in Table 1. ...
... One common type was a superficial insertion into a site not corresponding to any traditional acupuncture point, 18,25 'true' traditional acupuncture points (those classically selected for the treated condition) 17 or 'irrelevant' traditional acupuncture points (those not classically associated with the treated condition). 20,24 Another common type used a non-penetrating approach, [6][7][8]15,22 whether at traditional or non-traditional acupuncture points. Pseudo-intervention was also used as one of the sham therapies-for example, use of a toothpick in a needle guide tube, a guide tube without a needle, placebo TENS (not applied to traditional acupuncture points) and press needles. ...
Objectives:
To assess the evidence for the efficacy of acupuncture for non-specific low back pain (NSLBP), compared with sham or placebo therapies.
Methods:
We searched Cochrane CENTRAL to December 2016, and conducted searches from 1980 to December 2016 in PubMed, MEDLINE and Embase. There were no regional restrictions applied. We included only randomised controlled trials of adults with NSLBP. Placebo/sham procedures were required of the control interventions. The trials were combined using meta-analysis when the data reported allowed for statistical pooling.
Results:
14 trials (2110 participants) were included in the review, and 9 were included in the meta-analysis. Immediately after the acupuncture treatment we found statistically significant differences in pain reduction between acupuncture and sham or placebo therapy (standardised mean difference (SMD) -0.40, 95% CI -0.54 to -0.25; I2 7%; 753 participants; 9 studies), but there were no differences in function (weighted mean difference (WMD) -1.05, 95% CI -3.61 to 1.52; I2 79%; 462 participants; 4 studies). At follow-up, there were significant differences in pain reduction (SMD -0.46, 95% CI -0.82 to -0.09; I2 67%), but not in function (WMD -0.98, 95%CI -3.36 to 1.40; I2 87%). We conducted subgroup analyses both immediately after treatment and at follow-up.
Conclusion:
There is moderate evidence of efficacy for acupuncture in terms of pain reduction immediately after treatment for NSLBP ((sub)acute and chronic) when compared to sham or placebo acupuncture.
Registration:
PROSPERO registration no. CRD42017059438.
... In relative to the oral and surgical treatment of low back pain in LDH, acupuncture exhibits possible advantages in avoiding possible gastrointestinal adverse reactions of oral drugs and the secondary trauma of surgery. Meanwhile, existing systematic reviews [5,6], meta analysis [7], and randomized controlled studies [8,9] support that acupuncture has a good analgesic effect on low back pain. The Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians [10] and the Chinese Expert Consensus on "Rehabilitation Treatment of Lumbar Disc Herniation" issued by the Skeletal Muscle Professional Committee of the Rehabilitation Physician Branch of the Chinese Medical Doctor Association [1] all recommend acupuncture as a therapeutic measure for low back pain. ...
... Therefore, we chose a non-inferiority trial design. According to the previous literature [8,18] and the joint consideration of clinicians and statisticians, it is assumed that the standard deviation of VAS score reduction of patients using bamboobased medicinal moxibustion is 2.0, the non-inferiority margin was set at 0.78, the significance level of the test is unilateral 0.05 and power of the test is 90%. According to the 1:1 grouping, the sample size required by each group was 140 cases, and the lost follow-up rate will be estimated at 10%. ...
Background
Lumbar disc herniation (LDH) is a common and frequently occurring disease in clinics. Low back pain and sciatica are the presenting symptoms of LDH. To some extent, it can be considered that measures with the capability to improve low back pain or sciatica have the potential to treat LDH. Ma’s bamboo-based medicinal moxibustion therapy can effectively reduce the degree of low back pain and has been widely used. Studies of small sample size have seen significant improvement on pain relief. The aim of this trial is to evaluate the clinical efficacy and safety of Ma’s bamboo-based medicinal moxibustion therapy in the treatment of LDH low back pain.
Methods/design
The trial is a multicenter, randomized, parallel-group, non-inferiority study. Three hundred and twelve patients will be randomly assigned to a Ma’s bamboo-based medicinal moxibustion group ( n =156) and an acupuncture group ( n =156). Patients in each group will receive treatment every day, 6 times a week, 12 times in total. Follow-up will be conducted 14 days after treatment. The primary outcome will be the visual analog scale(VAS) at baseline, after 6 times of treatment, end of treatment, and follow-up. The secondary outcomes will include Oswestry disability indexes (ODI), modified Japanese Orthopaedic Association low back pain (M-JOA) score, serum β-endorphin (β-EP), and serum substance P (SP). β-EP and SP, as well as safety evaluation indexes (routine blood, liver, and kidney function and electrocardiogram), will be measure at baseline and after the end of treatment. The number, nature, and severity of adverse events will be recorded.
Discussion
The results of the trial will compare the efficacy of low back pain in LDH between Ma’s bamboo-based medicinal moxibustion group and the acupuncture group and will be expected to make a systematic and objective evaluation of the clinical efficacy and safety of Ma’s bamboo-based medicinal moxibustion therapy.
Trial registration
ChiCTR2000038725 . Registered on 29 September 2020.
... It found that acupuncture reduced pain intensity of chronic low back pain (measured with Visual Analog Scale) better than sham acupuncture (P < 0.05). In addition, depression level (measured with Beck Depression Inventory) of the acupuncture group was improved during the entire study (P < 0.01), but no significant effect was observed between the groups (Cho et al., 2013). ...
... Even if true acupuncture interventions do not seem to be superior to sham acupuncture (Karst et al., 2001;Linde et al., 2005;Melchart et al., 2005;Witt et al., 2005;Cho et al., 2013), in some cases, we cannot ignore the effect of acupuncture. This is because sham acupuncture (even if non-penetrating needles) may have direct physiological effects (Lund and Lundeberg, 2006;Napadow et al., 2009;Liu et al., 2017), and acupuncture may have a significant placebo effect, especially in studies with continuous subjective outcomes. ...
Accumulating evidence supports an association between chronic pain and psychological disorders, a connection that seems to be bidirectional. Treating both the pain and psychological conditions together is essential for effective treatment outcomes. Acupuncture is a somatosensory-guided mind–body therapy that can tackle the multidimensional nature of pain with fewer or no serious adverse effects. In this review, we discuss the use of acupuncture in some conditions with a high incidence of psychological disorders caused by chronic pain: headache, musculoskeletal pain, low back pain, and cancer pain, focusing on the effect and potential mechanisms of acupuncture. Overall clinical studies indicated that acupuncture might effectively contribute to management of psychological disorders caused by chronic pain. Mechanistic studies showed that acupuncture significantly alleviated such psychological disorders by regulating the activity of amygdala and insula, and regulating functional connectivity of insular and limbic regions/medial prefrontal cortex in humans and the corresponding animal models. In addition, 5-HT in the dorsal raphe nucleus, opioid receptors in the cingulate cortex, and plasma met-enkephalin are involved in acupuncture relief of pain and psychological symptoms. Substantial evidences from animal and human research support a beneficial effect of acupuncture in psychological disorders caused by chronic pain.
... 1.2 Low Back Pain: In a randomized controlled trial (RCT), 130 adults with low back pain were assigned to groups receiving either needle acupuncture or sham acupuncture, which involves using blunt needles without penetrating acupuncture points. Patients treated with needle acupuncture reported lower scores for pain [9], indicating that acupuncture has physiological effects beyond mere placebo. However, despite its relevance to analgesia, acupuncture remains controversial due to a lack of biological plausibility and its origins in theories outside of biomedicine [10]. ...
Introduction and purpose:
Many people worldwide suffer from chronic pain. It is a very inconvenient condition on its own, not only an accompanying symptom of other diseases. Conventional drug treatment may be insufficient in some cases or may even cause serious side effects in the long term. In response to this, we aim to demonstrate the diversity of alternative pain management techniques in this review and identify conditions where such techniques may be beneficial to patients.
State of knowledge:
This paper evaluates some of the most common alternative pain management methods (acupuncture, massage, chiropractic, mind body therapies, herbal medicine, music therapy) and their application in specific cases of chronic pain. We also describe the possible mechanisms of action involved in the effectiveness of these techniques, based on contemporary studies.
Summary:
In conclusion, there are conditions where alternative medicine may be beneficial for patients suffering from chronic pain. The studies taken into account showed the best effects for chronic musculoskeletal pain treated with methods such as acupuncture and massage. Mind-body therapies may reduce stress levels and symptoms of depression associated with chronic pain, consequently improving the quality of patients' lives. However, alternative methods should not yet be considered as replacements for conventional drug therapy. More studies are needed to evaluate whether alternative therapies will play a significant role in chronic pain management in the future.
... The role of microglia, as a first line of defense, is particularly crucial at this site; however, how electroacupuncture regulates spinal microglia polarization in lumbar SDH to alleviate pain is not well understood. In this study, the left side (ipsilateral to the surgery) equivalent of human acupuncture points 'Huantiao' (GB-30) and 'Yanglingquan' (GB-34) were used, which were used for the treatment of chronic pain caused by LDH clinically [32]. Previous studies have shown that acupuncture needles inserted into acupoints will not produce analgesic effect without electric stimulation (sham-electroacupuncture) or manual stimulation [33,34]. ...
Electroacupuncture has an effective analgesia on chronic pain caused by lumbar disc herniation (LDH) clinically, however, the underlying mechanism is unclear. In this study, we investigated whether electroacupuncture alleviated pain in LDH model rats by inducing spinal microglia M2 polarization. We established a noncompression LDH rat model by implanting autologous caudal nucleus pulposus into L5/L6 nerve root. Electroacupuncture (30 min/day) treatment on the ipsilateral side was started on the 8th postoperative day, once a day for consecutive 7 days. Paw withdrawal threshold (PWT) and paw withdrawal latency (PWL) were tested for pain behavior. Western blotting was used to detect the protein expression in lumbar enlargement (L5/L6). Immunofluorescence was used to detect iNOS+/Iba-1+ and Arg-1+/Iba-1+ and CB2R+/Iba-1+ in lumbar enlargement (L5/L6). We show that PWT and PWL decreased in the LDH group while Iba-1, iNOS, and TNF-α expression increased significantly in lumbar spinal dorsal horn (SDH) after LDH surgery, and revealing that microglia were activated and polarized towards proinflammatory M1 phenotype. Electroacupuncture treatment significantly increased PWT and PWL while reducing Iba-1, iNOS, and TNF-α expression, interestingly, Arg-1 and IL-10 expression were significantly increased. Moreover, electroacupuncture treatment led to CB2 receptors on microglia upregulation, while NF-κB and p-NF-κB expression in lumbar SDH downregulation. Our study indicated that electroacupuncture may reduce nociceptive hyperalgesia by inhibiting microglia activation and microglia M1 polarization and promoting microglia M2 polarization in lumbar SDH of LDH rats, which may be caused by the activation of CB2 receptors on microglia and inhibition of NF-κB pathway in lumbar SDH.
... The sample size for the present study was determined based on an effect size (d value) of 0.6 to detect the significance of the intervention effect on the primary outcome measure, namely the intergroup changes in HAM-D and BPI scores (Cho et al., 2013). In addition, we assumed a 5% chance of a type I error occurring (α = 0.05), a 20% chance of a type II error occurring (β = 0.2), and a 20% drop-out rate; thus, approximately 75 initial participants were required to achieve a sufficient sample size. ...
Background:
Depression and pain are highly comorbid and share biological mechanisms. Acupuncture is commonly used to manage both pain and depression, but the choice of acupoints for specific disorders differs. This study aimed to investigate whether specific acupuncture intervention on pain- and depression-acupoints would have specific efficacy and immune effects in patients with comorbid chronic pain and major depressive disorder (MDD).
Methods:
We performed a subject- and assessor-blinded, crossover, and randomized controlled clinical trial of depression- and pain-specific acupuncture intervention and measured clinical responses and proinflammatory cytokines in patients with comorbid chronic pain and MDD. Specific acupoints for pain and depression were used in random order with a washout interval. Forty-seven patients were enrolled and randomly assigned to two groups: (1) the depression-pain group (23 patients who were treated with depression-specific acupoints and then the pain-specific acupoints after the washout) and (2) pain-depression group (24 patients with the reverse order).
Results:
The pain-specific acupoints for pain did not reduce Brief Pain Inventory scores to a significantly greater degree (-0.97 ± 1.69) than the depression-specific acupoints (-0.28 ± 1.88); likewise, the depression-specific acupoints did not significantly ameliorate Hamilton Depression Rating Scale (-4.59 ± 6.02) than the pain-specific acupoints (-6.69 ± 6.61). The pain-specific acupoints improved Beck Depression Inventory-Second Edition (-6.74 ± 9.76) even better than the depression-specific acupoints (-1.92 ± 10.74). The depression-specific acupoints did not significantly decrease the depression-related interleukin (IL)-6 level (-1.24 ± 6.67) than the pain-specific acupoints (-0.60 ± 4.36). The changed levels of IL-1β, tumor necrosis factor (TNF)-α between the depression-specific acupoints (-37.41 ± 194.49; -12.53 ± 54.68) and the pain-specific acupoints (-15.46 ± 87.56; -7.28 ± 27.86) could not reach significantly different, too.
Conclusion:
This study rejected our hypothesis that the pain-specific acupoints might produce superior analgesic effects than the depression-specific acupoints and vice versa. The cytokine results might imply that pain and depression share common biological mechanisms. (trial registration: https://www.
Clinicaltrials:
gov: NCT03328819).
... 59 In several multicenter RCT, patients with chronic low back pain, who received acupuncture, reported no major or systemic adverse effects. 53,62,63 Likewise, patients with chronic neck pain, who received acupuncture, have not re- The three treatments studied (VGAIT, real, and sham acupuncture) resulted in decreased pain severity as measured by chronic low back pain severity score. No statistical difference in pain relief was found between VGAIT, real acupuncture, or sham acupuncture. ...
Background
Chronic pain is a multifactorial condition that is afflicting populations worldwide causing an increasing economic, physical, mental, and emotional burden. Treatments range from medications to interventional procedures to complementary and alternative medicine (CAM), such as acupuncture. This review aims to discuss the use of acupuncture in the treatment of chronic pain, proposed mechanisms, indications, and efficacy for various chronic pain conditions.
Results
Evidence is varied on the efficacy and quality of data on the use of acupuncture in the treatment of chronic pain. Recent studies have demonstrated promising results in the support of acupuncture for the use in the treatment of cancer, neck, and back pain, functional dyspepsia, and various chronic abdominal pain syndromes.
Conclusion
Acupuncture, deemed well-tolerated and safe to use, has been increasingly studied and is regarded as effective in clinical practice, but its efficacy is limited by the lack of well-conducted, high-quality clinical trials, lower quality evidence, and conflicting study results. Additionally, the exact analgesic mechanism of acupuncture remains to be fully elucidated. Increasing evidence supports the role of acupuncture as therapy in the treatment of cancer, neck, and back pain and functional dyspepsia. Further rigorous studies are needed to fully assess the use of acupuncture in various chronic pain conditions, determine its indications, and optimal treatment schedule. Overall, future studies could benefit from better designed experimental studies, larger groups, and more objectives ways to measure pain reduction and symptom improvement.
... From the viewpoint of Western medicine, the main theories and hypotheses related to the physiological effects of pain reduction would be the gate control theory of pain, the control of diffuse harmful inhibitors and theory of the reflection zone, in which pain relief is achieved through the inhibition of receptors conducting pain stimuli [8,11,13] [19,20,47]. However, it is important to consider the multi-causality of this pain condition [48][49][50], including psychosocial factors, which are strongly related to the onset of pain [51,52]. ...
Background:
Cupping therapy is used to treat musculoskeletal conditions, including low back pain.
Objectives:
The study assessed the effects of dry cupping on pain and functional disability from persistent nonspecific low back pain.
Methods:
This was a randomized controlled trial, where participants were allocated to a cupping therapy (n = 19) or sham (n = 18) group, for five 10-minute sessions of cupping therapy, twice a week, to stimulate the acupoints related to low back pain (GV4, BL23, BL24, BL25, and BL30, BL40 and BL58) and emotional aspects (HT3 and ST36). All participants were assessed at baseline, post-treatment and follow up (a finalization period of four weeks) using a visual analogue scale (VAS) and the Oswestry Disability Index (ODI). Groups were compared using the analysis of covariance (ANCOVA) and the effect size was calculated using Cohen̓s d.
Results:
The cupping therapy group presented a lower mean VAS when compared to the sham, at post-treatment (mean difference: -2.36; standard error [SE]: 0.58; p < 0.001; "large" effect size: -0.94) and follow up (mean difference: -1.71; SE: 0.81; p < 0.042; 'large' effect size: -0.83). The cupping therapy group presented a lower mean ODI when compared to the sham post-treatment (mean difference: -4.68; SE: 1.85; p: 0.017; 'large' effect size: -0.87), although in follow-up, there was no difference between the groups (mean difference: 4.16; SE: 2.97; p: 0.17; "medium" effect size: -0.70).
Conclusion:
Dry cupping was more effective in improving pain and functional disability in people with persistent nonspecific low back pain when compared to the sham.
... In a systematic review [303], pain was reduced more than by medication or sham acupuncture, but there was no difference in 2) Acupuncture for chronic low back pain Five RCTs [304e308] were extracted to examine the effectiveness of acupuncture. Two RCTs [307,308] showed that acupuncture was effective in improving chronic LBP, and four RCTs [304,305,307,308] regarding improvement of functional impairment showed the effectiveness of acupuncture for a short period of time. One RCT by Weiss et al. reported excellent effects on physical functioning, general health, vitality, and role emotional in healthrelated QOL evaluated by the MOS SF-36 [309]. ...
Background
The latest clinical guidelines are mandatory for physicians to follow when practicing evidence-based medicine in the treatment of low back pain. Those guidelines should target not only Japanese board-certified orthopaedic surgeons, but also primary physicians, and they should be prepared based entirely on evidence-based medicine. The Japanese Orthopaedic Association Low Back Pain guideline committee decided to update the guideline and launched the formulation committee. The purpose of this study was to describe the formulation we implemented for the revision of the guideline with the latest data of evidence-based medicine.
Methods
The Japanese Orthopaedic Association Low Back Pain guideline formulation committee revised the previous guideline based on a method for preparing clinical guidelines in Japan proposed by Medical Information Network Distribution Service Handbook for Clinical Practice Guideline Development 2014. Two key phrases, “body of evidence” and “benefit and harm balance” were focused on in the revised version. Background and clinical questions were determined, followed by literature search related to each question. Appropriate articles were selected from all the searched literature. Structured abstracts were prepared, and then meta-analyses were performed. The strength of both the body of evidence and the recommendation was decided by the committee members.
Results
Nine background and nine clinical qvuestions were determined. For each clinical question, outcomes from the literature were collected and meta-analysis was performed. Answers and explanations were described for each clinical question, and the strength of the recommendation was decided. For background questions, the recommendations were described based on previous literature.
Conclusions
The 2019 clinical practice guideline for the management of low back pain was completed according to the latest evidence-based medicine. We strongly hope that this guideline serves as a benchmark for all physicians, as well as patients, in the management of low back pain.
... The trial was aimed to determine whether there was a difference among the EA group, MA group, and SA group in terms of NRS scores. The sample size was calculated based on the previous study [30] through the PASS system (version 15.0.5), with the assumption of the difference in the mean NRS scores between the MA group and SA group as 1.5 and the standard deviation as 2.0. Thirty-nine participants per group would be required to provide 90% power with a two-sided significance level of 5%. ...
Background
Persistent pain following back surgery called failed back surgery syndrome remains a major treatment challenge. The aim of this study is to evaluate the efficacy and safety of electroacupuncture on relieving back pain in FBSS patients.
Methods/design
This is a randomized, single-blind, single-site, placebo-controlled trial. A total of 144 eligible FBSS patients will be randomly assigned to the electroacupuncture, manual acupuncture, or sham acupuncture group in a 1:1:1 ratio. Each group will receive 2 treatment sessions per week for 12 weeks. The primary outcome will be low back pain intensity based on the 11-point numerical rating scale (NRS). The secondary outcomes include Oswestry Disability Index (ODI) questionnaire, Beck Depression Inventory-II (BDI-II), Pittsburgh Sleep Quality Index (PSQI), and analgesic consumption. All clinical outcomes will be collected at baseline, during the treatment phase (at 8 and 12 weeks), and at the 16-, 24- and 36-week follow-ups. All data will be analyzed based on the intention-to-treat principle and adverse events will be assessed during the trial.
Discussion
This pilot randomized controlled trial will evaluate the efficacy of electroacupuncture for treating failed back surgery syndrome. The outcomes will determine whether electroacupuncture is efficacious in relieving low back pain as well as improving the quality of life in failed back surgery syndrome patients.
Trial registration
Chinese Clinical Trial Registry ChiCTR2000040144 . Registered on 22 November 2020
... Placebo acupuncture means that a semiblunt retractable needle did touch but did not pierce the skin. 16 Sham acupuncture refers to a needle set on nonacupuncture points or acupuncture points not related to LBP. 17 A modified nonfunctioning electroacupuncture stimulator was used to contrast with real electroacupuncture. ...
Objective:
This study aims to improve the reporting quality of randomized controlled trials (RCTs) by evaluating RCTs of acupuncture for low back pain (LBP) based on the CONSORT and STRICTA statements.
Methods:
Literature from the Cochrane Library, Medline, Embase, Ovid, China National Knowledge Infrastructure (CNKI), WanFang database, and Chongqing Weipu (VIP) was systematically searched from 2010 to 2020. The general characteristics and the overall quality score (OQS) of the literature were evaluated by two investigators. The agreement between investigators was calculated using Cohen's kappa statistics.
Results:
A total of 31 RCTs were extracted in the final analysis. Based on the CONSORT statement, the items "title and abstract", "background and objectives", "intervention", "outcomes", "statistical methods", "baseline data", "outcomes and estimation" and "interpretation" have a positive rate of greater than 80%. The items "implementation", "generalizability" and "protocol" have a positive rate of less than 30%. Based on the STRICTA statement, the items "style of acupuncture", "needle retention time", "number of treatment sessions", "frequency and duration of treatment" and "precise description of the control or comparator" have a positive rate of greater than 80%. The item "extent to which the treatment was varied" has a positive rate of less than 30%. The agreements among most items are determined to be moderate or good.
Conclusion:
The reporting quality of RCTs of acupuncture for LBP is moderate. Researchers should rigidly follow the CONSORT and STRICTA statements to enhance the quality of their studies.
... Thirty-four of the 49 RCTs were performed at a single center [14, 15, 17, 19-21, 23-27, 29, 31, 32, 34, 35, 37, 39, 40, 42-45, 47-53, 57-60], and 15 were multicenter [12,13,16,18,22,28,30,33,36,38,41,46,[54][55][56]. Twenty RCTs were performed in a double-blind manner [20, 21, 25, 30, 32-42, 52, 54-56, 58], and 14 were single-blind [12, 14, 15, 17-19, 23, 24, 27, 29, 45, 47, 51, 53]. ...
Background:
The dropout rate is an important determinant of outcomes in randomized controlled trials (RCTs) and should be carefully controlled. This study explored the current dropout rate in studies of Korean medicine (KM) interventions by systematic evaluation of RCTs conducted in the past 10 years.
Methods:
Three clinical trial registries (Clinical Research Information Service, ClinicalTrials.gov, and World Health Organization International Clinical Trials Registry Platform) were searched to identify RCT protocols for KM interventions, such as acupuncture, herbal medicine, moxibustion, or cupping, and studies of mixed interventions, registered in Korea from 2009 to 2019. The PubMed, Embase, and OASIS databases were searched for the full reports of these RCTs, including published journal articles and theses. Dropout rates and the reasons for dropping out were analyzed in each report. The risk of bias in each of the included studies was assessed using the Cochrane risk of bias tool. The risk difference for dropping out between the treatment and control groups was calculated with the 95% confidence interval in a random effects model.
Results:
Forty-nine published studies were included in the review. The median dropout rate was 10% in the treatment group (interquartile range 6.7%, 17.0%) and 14% in the control group (interquartile range 5.4%, 16.3%) and was highest in acupuncture studies (12%), followed by herbal medicine (10%), moxibustion (8%), and cupping (7%). Loss to follow-up was the most common reason for dropping out. The risk difference for dropping out between the intervention and control groups was estimated to be 0.01 (95% confidence interval - 0.02, 0.03) in KM intervention studies.
Conclusions:
This review found no significant difference in the dropout rate between studies according to the type of KM intervention. We recommend allowance for a minimum dropout rate of 15% in future RCTs of KM interventions.
Review protocol registration:
PROSPERO CRD42020141011.
... Sham acupuncture in this study was defined by using blunt needles without penetration on acupuncture points. This demonstrates that acupuncture has more than a placebo psychologic effect and there is a physiologic mechanism underlying its success [22]. In addition, standard acupuncture therapy is shown to be equally effective to individualized therapy for patients [23]. ...
Introduction:
Non-pharmacologic alternative therapies for pain have been around for a long time, some for hundreds of years. They have been used throughout history to treat many issues.
Recent findings:
Currently, alternative medicine is most frequently used to treat musculoskeletal pain, and between 59 and 90% of patients utilizing alternative therapies for chronic pain claimed they were helpful and can serve as an effective adjunctive for the treatment of chronic pain. Some examples of alternative therapies that will be discussed in this review include acupuncture, tai chi, osteopathic manipulation, and chiropractic care. Acupuncture, traditionally a Chinese practice, is becoming more popular across the world to attempt to relieve pain. It involves the placement of thin needles at various points in the body. The efficacy of acupuncture for pain is heavily debated. More research and discussion are necessary to determine the exact role it plays in the treatment of chronic pain. Tai chi is also a traditional Chinese practice that is often used as a form of meditation and for potential health benefits. Tai chi involves a series of complex movements such as squatting combined with deep breathing to achieve relaxation and pain reduction. Osteopathic manipulative treatment (OMT) is a technique used by both osteopathic physicians (DO) as well as other health professionals to manage a wide range of conditions in any given patient. The technique involves utilization and manipulation of the musculoskeletal system to achieve potential health benefits. OMT has been used as therapy for many issues but is commonly used for pain conditions. Alternative therapies may serve as an effective adjunctive treatment modality for the management of chronic pain conditions. There has been a tremendous amount of research dictating the effectiveness of alternative therapies for chronic pain management. The purpose of this review is to provide a comprehensive evidence-based update of alternative therapy used for the management of chronic pain conditions.
... [12,13] Recently, clinical studies have proved acupuncture is beneficial for the treatment of CLBP. [14][15][16][17][18][19][20][21] Meanwhile, moxibustion is a form of TCM that has been widely used in East Asia for thousands of years. [22] In recent years, a number of basic and clinical studies have proved moxibustion is beneficial for the treatment of CLBP. ...
Background:
chronic low back pain (CLBP) are common symptoms bothering people in daily life. Traditional Chinese medicine (TCM) nonpharmacological interventions are gaining an increasing popularity for CLBP. Nevertheless, the evidence of efficacy and safety of random controlled trials (RCTs) remains controversial. This study aims to evaluate the efficacy and acceptability of different TCM nonpharmacological therapies by systematic review and network meta-analysis.
Methods:
According to the strategy, The authors will retrieve a total of 7 electronic databases by September 2020, including PubMed, the Cochrane Library, EMbase, China National Knowledge Infrastructure, China Biological Medicine, Chongqing VIP, and Wan-fang databases After a series of screening, 2 researchers will use Aggregate Data Drug Information System and Stata software to analyze the data extracted from the randomized controlled trials of TCM nonpharmacological interventions for CLBP. The primary outcome will be the improvement of Pain intensity and functional status/disability and the secondary outcomes will include lobal improvement, health-related quality of life, satisfaction with treatment, and adverse events. Both classical meta-analysis and network meta-analysis will be implemented to investigate direct and indirect evidences on this topic. The quality of the evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation instrument.
Results:
This study will provide a reliable evidence for the selection of TCM nonpharmacological therapies in the treatment of CLBP.
Conclusion:
This study will generate evidence for different TCM nonpharmacological therapies for CLBP and provide a decision-making reference for clinical research.
Ethics and dissemination:
This study does not require ethical approval. The results will be disseminated through a peer-reviewed publication.
Osf registration number:
DOI 10.17605/OSF.IO/4H3Y9.
... There are several reports on the effects of CAM treatment on musculoskeletal disorders in clinical studies. [6,7] However, in the systematic literature review, treatment protocols differ for each study, many are of small size, and there are few related studies to draw clear conclusions. [8,9] Particularly, safety-related studies may require more subjects, but because CAM treatment studies thus far have often involved a small number of patients, prospective safety data in large number of patients are necessary. ...
We developed a protocol for a prospective registry to prove the effectiveness and safety of integrative Korean medicine treatment for inpatients with sciatica due to lumbar intervertebral disc herniation. We plan on recruiting 1000 inpatients receiving integrative Korean medicine treatment for lumbar intervertebral disc herniation at four spine specialized Korean medical hospitals. Patients enrolled in the registry will be evaluated at the time of hospitalization, 2 weeks after hospitalization, at discharge, and 6 months after hospitalization on predefined outcome variables such as intensity of back and leg pain, Oswestry Disability Index, quality of life, Patient Global Impression of Change, and adverse effects. The protocol of this study was registered in CRIS (KCT0003709) and Clinical trial gov (NCT03750591). This study is significant in that it cannot only be a basis for safety-related evidence of complementary alternative medicine, which has been lacking, but it also gives clear evidence on the effectiveness and validity of treatment effects such as accompaniment of stenosis, sex, age, and type of disc herniation.
... Four studies used the Allgemeine Depressionsskala [21; 27; 28; 32]. The Beck Depression Inventory, recommended by IMMPACT, was used as instrument to measure the emotional state of patients only in the study by Cho et al [41]. Improvement perception and patient satisfaction. ...
Acupuncture is one of the therapeutic resources used for the management of chronic pain. Variability in outcome measurements in randomized clinical trials of non-oncologic chronic pain (RCT-NOCP) generates inconsistencies in determining effects of treatments. The objective of this survey was to assess the adherence to the recommendations made by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) in the measurement of RCT-NOCP of acupuncture. This methodological research made a systematic search for eligible studies from different sources of information. Eligible studies included those with number of patients ≥100, who randomized and allocated patients with chronic non-oncologic pain to be treated with acupuncture or with “sham” acupuncture, or non-acupuncture. This research included the recommendations for IMMPACT in the measurement of RCT-NOCP: presence of outcomes pain, physical function, emotional state and improvement perception of patient, the source of the outcome information pain and the tools used to measure such domains. From a total of 1,386 studies, 24 were included in this survey. Eleven studies presented low risk of bias. Pain outcome was measured in 23 studies, physical function in 22 studies, emotional state in 14 studies and improvement perception of patient in one study. As for the pain outcome, the patient was the information source in 50% of the studies. The measurement tools recommended for IMMPACT were included in eight studies (35%) that evaluated pain, one study that evaluated the emotional state (7%), and one study that evaluated the improvement perception and satisfaction of patient. It was observed that studies which did not adhere to the recommendations had more favorable results for acupuncture in the outcome pain. This study concludes that randomized clinical trials that used acupuncture to manage chronic pain failed to adhere to IMMPACT recommendations. Clinical societies and IMMPACT do not share the same recommendations. This fact reflects in the diversity of outcomes and instruments adopted in the studies, making it difficult to compare the results.
... It has been proven as an effective supplement to other forms of conventional medical therapy for nonspecific cLBP. 13 In the therapy method, very fine, solid metallic needles are inserted into or through the skin at specific points in ears, hands and body, which is effective with less side-effect. Acupuncture is believed originated in China and is the most widely practiced across the world. ...
Objective:
To evaluate the effect of hand-ear acupuncture on chronic low-back pain (cLBP).
Methods:
This was an open, randomized and controlled trial in The General Hospital of Western Theater Command, Sichuan Province. The trial was registered with ClinicalTrials.gov, NCT02260284. All the 152 participates with cLBP were randomly assigned to hand-ear acupuncture (n = 54), standard acupuncture (n = 50), or usual care groups (n = 48). Eighteen treatments were provided over 7 weeks. Back-related dysfunction and symptom severity were assessed by the Roland-Morris Disability Questionnaire (RMDQ) and the Visual Analogue Scale (VAS), which were collected at baseline, 2 months and 6 months post to the treatment.
Results:
At 6 months, the RMDQ scores improved by 7.74 points of hand-ear acupuncture group. Significant improvement of VAS and RMDQ was observed in hand-ear acupuncture group (P < 0.001), but no significant changes of RMDQ were observed in both standard acupuncture group and usual care group. We also observed an overall efficacy rate of 88.89% in hand-ear acupuncture group, as evaluated by Diagnosis and Curative Effect Standard for Symptom pattern of Traditional Chinese Medicine, which was much higher than 45.84% in the usual care group (H = 16.000, P < 0.001).
Conclusion:
Both of the hand-ear acupuncture and standard acupuncture modes have beneficial and persistent effectiveness against cLBP compared with the usual care. Furthermore, hand-ear acupuncture is significantly more effective than the standardized acupuncture, especially in the long term.
... 13 Increased communication between physicians and patients could also lead to more optimal care that integrates CIH modalities into multimodal therapeutic approaches. For example, clinical trials support integrating acupuncture into the management of cancer-related pain and nausea 14 and chronic musculoskeletal pain treatment, 15 and observational studies suggest that chiropractic care may complement conventional care for migraine headache. 16 Lack of communication could lead to missed opportunities for physicians to advise on CIH safety or to develop an integrated care plan. ...
Background:
Effective patient-doctor communication about complementary and integrative health (CIH) is crucial to coordinate multimodal treatment for complex conditions. While rates of patient disclosure of CIH use to physicians have increased in the United States over the last 30 years, many patients still do not disclose these facts. Integrating CIH approaches within academic medical centers may enhance the communication, but this has not been explicitly studied.
Objective:
To examine rates of patient disclosure of CIH to physicians and reasons for nondisclosure.
Methods:
We surveyed 1177 patients at an academic center's CIH clinic regarding their CIH use and disclosure of CIH use to their physician.
Results:
Of the 1067 who responded to the disclosure questions, 80.1% had discussed their CIH use with their physician, while 19.9% did not. Of those who did not disclose, lack of physician inquiry was reported by 58% as the principal reason.
Discussion:
Within an academic center, there is still a need to improve communication about CIH use. Possible strategies might include continued education of both patients and physicians about CIH and communication skills and integration of CIH disclosure into routine patient health questionnaires.
... 634 -637,639 Thus, low-level laser therapy is Not Recommended (C), Moderate Confidence for treatment of LBP. 264,623,[634][635][636][637][638][639] ACUPUNCTURE There are 10 high-quality [640][641][642][643][644][645][646][647][648][649][650] (one with two reports) and 25 moderatequality 273,396,511,623,637,638,[651][652][653][654][655][656][657][658][659][660][661][662][663][664][665][666][667][668][669][670] studies (one with two reports) incorporated into this analysis. Trials enrolling only the elderly were not included. ...
... Particularly, acupuncture is a wellknown treatment for CLBP. Various studies have reported on the effects on pain [10] and the pragmatic aspects [11] of acupuncture in treating CLBP and some have suggested that acupuncture has more effect on the reduction of pain and bothersomeness than sham control in patients with CLBP [12]. Several studies have investigated the clinical effect of acupuncture combined with other treatments such as direct moxibustion [13], physiotherapy [14], and pharmacopuncture [15]. ...
Background:
Low back pain is a common symptom and continuous or recurrent pain results in chronic low back pain (CLBP). While many patients with CLBP have tried various treatments, complementary and alternative medicine including acupuncture and herbal medicine is one of the commonly used treatments. Palmijihwang-hwan is a herbal medicine used frequently in clinical practice but there has been no report of the efficacy, safety, or cost-effectiveness analysis of Palmijihwang-hwan for CLBP.
Methods:
This study is a randomized, assessor-blinded, multicenter, clinical trial with two parallel groups. Four Korean medicine hospitals will recruit 84 participants and randomly allocate them into the control or treatment group in a 1:1 ratio. The control group will receive acupuncture treatment at 11 local and 4 distal acupuncture points for 20 min twice a week for 6 weeks. The treatment group will receive the same acupuncture treatment as the control group and also take Palmijihwang-hwan for 6 weeks. The primary outcome will be the change in visual analog scale (VAS) score between baseline (visit 1) and completion of the intervention (visit 12), and secondary outcomes will be pain-related clinical relevance (minimal clinical important difference or the proportion of the participants who decrease more than 30, or 50% on VAS), disability (Roland and Morris Disability Questionnaire), quality of life (EuroQol-5D), global assessment (Patient Global Impression of Change), and economic analysis (cost-effectiveness and cost-utility analysis). Additionally, safety will be assessed.
Discussion:
The results of our study will provide the clinical evidence about the efficacy, safety, and cost-effectiveness analysis of Palmijihwang-hwan for CLBP. There will be a chance to provide multiple subdivided influence of this treatment with various outcome measures, but lack of placebo is our limitation.
Trial registration:
Clinical Research Information Service, KCT0002998. Registered on 12 July 2018.
... Acupuncture treatments were performed at acupoints GB30 and GB34 (AP1 group), HT7 and GV20 (AP2 group), or two control points (CP group) bilaterally, which continued daily for 28 consecutive days starting from day 7 after surgery ( Figure 1A). GB30 (at the junction of the lateral 1/3 and medial 2/3 of the greater trochanter with the sacral hiatus) and GB34 (in the depression anterior and distal to the head of the fibula) are combinations of acupoints that are utilized for the treatment of lumber neuropathic pain in the clinic (Cho et al., 2013;Ju et al., 2017). HT7 (radial to the flexor carpi ulnaris tendon on the palmar crease) and GV20 (on the vertex of the head) are combinations of acupoints frequently used for the treatment of cognitive and emotional impairments (Lee et al., 2012;Chen et al., 2016;Fleckenstein et al., 2018;Yu et al., 2018). ...
Growing evidence indicates that neuropathic pain is frequently accompanied by cognitive impairments, which aggravate the quality of life of chronic pain patients. Here, we investigated whether acupuncture treatments can improve cognitive dysfunction as well as allodynia induced by neuropathic pain in mice. One week after the left partial sciatic nerve ligation (PSNL), acupuncture treatments on the acupoints GB30-GB34 (AP1), HT7-GV20 (AP2), or control points (CP) were performed for 4 weeks. Notably, the significant attenuations of mechanical allodynia and cognitive impairment were observed in the AP1 group, but not in PSNL, AP2, or CP groups. A random decision forest classifier based on the pain and cognitive functions displayed that the acupuncture group was clearly segregated from the other groups. We also demonstrated that acupuncture restored the reduced field excitatory post-synaptic potentials and was able to elevate the expression levels of glutamate receptors (NR2B and GluR1) in the hippocampus. Moreover, the expressions of Ca2+/calmodulin-dependent protein kinase II and synaptic proteins (pPSD-95 and pSyn-1) were enhanced by acupuncture treatment. These results suggest that acupuncture can enhance hippocampal long-term action through the regulation of the synaptic efficacy and that acupuncture may provide a viable option for managing both pain and cognitive functions associated with chronic neuropathic pain.
... The clinical research evidence supported that acupuncture can significantly relieve the pain of patients with LBP compared with sham acupuncture or no acupuncture. [21][22][23][24] Research shows that acupuncture can play a role in the pain relief through several mechanisms. First, acupuncture can regulate opioid release via inhibiting the dorsal horn to relieve pain. ...
Objective:
The aim of this study was to evaluate the effect of acupuncture injection therapy for the patients with nonspecific chronic low back pain (CLBP) systematically.
Methods:
Four English online databases and 4 Chinese online databases will be researched systematically from their inception to December 31, 2018. Reference management software, Endnote X7, will be used to manage and screen the records. After removing the duplicate records, 2 independent reviewers will select the studies that meet the inclusion criteria. "Risk of table" recommend by Cochrane Handbook for Systematic Reviews of Interventions will be used to judge the quality of the included records. All data will be extracted by 1 reviewer and checked by another reviewer. Any disagree will be addressed via consulting a third reviewer in the above processes. Microsoft Excel will be used to manage and convert data if necessary. The missing data will be obtained via emailing the original authors of included studies. Review Manager (RevMan5.3) will be used to perform the data synthesis if enough data were collected. Otherwise, only the qualitative analysis will be performed. Based on the heterogeneity results, fixed-effect model or random-effect model will be used to estimate the overall effect of acupuncture injection therapy for patients with nonspecific CLBP. Meta-regression and subgroup analysis will be also performed to explore the sources of heterogeneity. If there are enough records included, the publish bias will be assessed by funnel plot. All procedures will be strictly performed in accordance with the Cochrane Handbook for Systematic Reviews of Interventions.
Conclusion:
This review will offer clinical evidence of acupuncture injection therapy for the patients with nonspecific CLBP.
Prospero research registration identifying number:
CRD42019119158.
Importance:
When sham acupuncture is set as a control in evaluating acupuncture, the sham needling technique is usually different from acupuncture. However, the sham procedure is conducted either at the same points that are used for the acupuncture group or at nonindicated points.
Objective:
To assess whether the outcome of sham acupuncture varies according to the needling points in sham-controlled trials of acupuncture for chronic nonspecific low back pain (CLBP) as an example.
Data sources:
Searches of MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and the Allied and Complementary Medicine Database were conducted on February 12, 2023.
Study selection:
Randomized clinical trials (RCTs) assessing the outcomes of acupuncture in sham acupuncture-controlled or waiting list-controlled trials on CLBP were included.
Data extraction and synthesis:
Two researchers independently extracted data on study characteristics and outcomes and assessed quality. Sham acupuncture was classified according to whether it was conducted at the same acupuncture points used in the acupuncture group, referred to as sham acupuncture therapy (verum) (SATV) or at different points, referred to as sham acupuncture therapy (sham) (SATS). Clinical similarity, transitivity, and consistency tests were conducted, followed by a random-effects frequentist network meta-analysis (NMA).
Main outcomes and measures:
The primary outcome was pain, and the secondary outcome was back-specific function. The first assessment after the end of treatment was chosen for analysis. Effect sizes are reported as standardized mean differences (SMD) with 95% CIs. The risk of bias was assessed using the Cochrane risk of bias tool, and the certainty of evidence for findings was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation approach.
Results:
Ten RCTs involving 4379 participants were included. In comparison with SATS, acupuncture was significantly associated with improvements in both pain (SMD, -0.33; 95% CI, -0.52 to -0.15) and function outcomes (SMD, -0.13; 95% CI, -0.25 to -0.02); however, there were no differences between acupuncture and SATV. In comparison with SATS, SATV was significantly associated with better pain (SMD, -0.45; 95% CI, -0.88 to -0.03) and function outcomes (SMD, -0.30; 95% CI, -0.56 to -0.05). The risk of bias that could affect the interpretation of the results was usually low, and the certainty of evidence was moderate to low.
Conclusions and relevance:
In this NMA, sham acupuncture needling at the same points as those in acupuncture was not a true placebo control for assessing the efficacy of acupuncture for CLBP and might underestimate the outcome of acupuncture in clinical settings.
Background:
Low back pain (LBP) is a prevalent and debilitating condition that poses a significant burden on healthcare systems. Acupuncture has been proposed as a promising intervention for LBP, but the evidence supporting its specific effect is insufficient, and the use of sham acupuncture as a control in clinical trials presents challenges due to variations in sham acupuncture techniques and the magnitude of the placebo effect.
Objective:
To investigate the magnitude of the placebo response of sham acupuncture in trials of acupuncture for nonspecific LBP, and to assess whether different types of sham acupuncture are associated with different responses.
Methods:
Four databases including PubMed, EMBASE, MEDLINE, and the Cochrane Library were searched through April 15, 2023, and randomized controlled trials (RCTs) were included if they randomized patients with LBP to receive acupuncture or sham acupuncture intervention. The main outcomes included the placebo response in pain intensity, back-specific function and quality of life. Placebo response was defined as the change in these outcome measures from baseline to the end of treatment. Random-effects models were used to synthesize the results, standardized mean differences (SMDs, Hedges'g) were applied to estimate the effect size.
Results:
A total of 18 RCTs with 3,321 patients were included. Sham acupuncture showed a noteworthy pooled placebo response in pain intensity in patients with LBP [SMD -1.43, 95% confidence interval (CI) -1.95 to -0.91, I2=89%]. A significant placebo response was also shown in back-specific functional status (SMD -0.49, 95% CI -0.70 to -0.29, I2=73%), but not in quality of life (SMD 0.34, 95% CI -0.20 to 0.88, I2=84%). Trials in which the sham acupuncture penetrated the skin or performed with regular needles had a significantly higher placebo response in pain intensity reduction, but other factors such as the location of sham acupuncture did not have a significant impact on the placebo response.
Conclusions:
Sham acupuncture is associated with a large placebo response in pain intensity among patients with LBP. Researchers should also be aware that the types of sham acupuncture applied may potentially impact the evaluation of the efficacy of acupuncture. Nonetheless, considering the nature of placebo response, the effect of other contextual factors cannot be ruled out in this study. (PROSPERO registration No. CRD42022304416).
Acupuncture has been used as a therapeutic intervention for the treatment of numerous diseases and symptoms for thousands of years, and low back pain has been studied and treated the most in acupuncture clinics. Traditional theory strongly suggests that the selection of acupoints will influence their clinical effects and combinations (e.g., the clinical effects of a particular acupoint or combination on reducing pain), but this idea was not considered in earlier systematic reviews and meta-analyses. We performed a systematic review, meta-analysis, and network analysis to evaluate the magnitude of the effects of acupoints used to treat low back pain in randomized controlled clinical trials. We found that acupuncture significantly reduced pain in patients with low back pain compared with the control group. The most frequently prescribed acupoints were BL23, GV3, BL20, BL40, and BL25, whereas the acupoints with the highest average effect size scores were BL20, GV3, GB30, GB34, and BL25. Further, the combinations of BL23-BL40, BL23-B25, and BL23-BL60 were the most frequently prescribed, while BL23-GV3, BL40-GV4, and BL23-BL25 showed the largest average effect size. By calculating clinical outcomes based on average effect sizes, we found that the most popular acupoints might not always be associated with the best results. Although a more thorough investigation is necessary to determine the clinical effects of each acupoint and combination on patients, we suggest that our approach may offer a fresh perspective that will be useful for future research.
Low back pain (LBP) commonly happens and affects people in various types of work. High cholesterol level is not only a risk for plaque in the blood vessels but also a risk for LBP pain. The aim was to analyze the biochemistry of cholesterol in LBP patients receiving acupuncture therapy. The quasi-experimental design with a pretest-posttest control group design was used at Griya Sehat Dewandaru and Prima Diagnostik Main Clinical Laboratory from March to November 2020. The total sample used was 30 patients, aged 40-60 years old, and reported Visual Analog Scale (VAS) pain scale 5-7. Acupuncture therapy was performed 10 times. Data were taken directly before therapy [T0], after five times [T5], and after ten times of therapy [T10]. The blood lipid profile assessment was carried out at T0, T5, and T10 and analyzed using SPSS version 23. The normality test using the Shapiro-Wilk test showed cholesterol, HDL, LDL, and VAS were normally distributed, while triglycerides were normally distributed by the Chi-Square test. Paired T-test results on cholesterol, LDL, and VAS showed a significant difference for all groups (p=0.000). Acupuncture therapy with a combination of local points and Yamamoto New Scalp Acupuncture [YNSA] points as much as 10 times was proven to reduce cholesterol by 12.6%, LDL by 20%, and VAS by 67.67%.
Background context
Currently, there are no published studies that compare non-pharmacological, pharmacological and invasive treatments for chronic low back pain in adults and provide summary statistics for benefits and harms.
Purpose
The aim of this review was to compare the benefits and harms of treatments for the management of chronic low back pain without radiculopathy and to report the findings in a format that facilitates direct comparison (Benefit-Harm Scale: level 1 to 7).
Design
Systematic review and meta-analysis of randomized controlled trials, including trial registries, from electronic databases up to 23rd May 2022.
Patient sample
Adults with non-specific chronic low back pain, excluding radicular pain in any clinical setting.
Outcome measures
Comparison of pain at immediate-term (≤2 weeks) and short-term (>2 weeks to ≤12 weeks) and serious adverse events using the Benefit-Harm Scale (level 1 to 7).
Methods
This was a registered systematic review and meta-analysis of randomized controlled trials. Interventions included non-pharmacological (acupuncture, spinal manipulation only), pharmacological and invasive treatments compared to placebo. Best evidence criteria was used. Two independent reviewers conducted eligibility assessment, data extraction and quality appraisal.
Results
The search retrieved 17,362 records. Three studies provided data on the benefits of interventions, and 30 provided data on harms. Studies included interventions of acupuncture (n = 8); manipulation (n = 2); pharmacological therapies (n = 9), including NSAIDs and opioid analgesics; surgery (n = 8); and epidural corticosteroid injections (n = 3). Acupuncture (standardized mean difference (SMD) -0.51, 95%CI -0.88 to -0.14, n = 1 trial, moderate quality of evidence, benefit rating of 3) and manipulation (SMD -0.39 (96%CI -0.56 to -0.21, n = 2 trials, moderate quality of evidence, benefit rating of 5) were effective in reducing pain intensity compared to sham. The benefit of the other interventions was scored as uncertain due to not being effective, statistical heterogeneity preventing pooling of effect sizes, or the absence of relevant trials. The harms level warnings were at the lowest (e.g. indicating rarer risk of events) for acupuncture, spinal manipulation, NSAIDs, combination ingredient opioids, and steroid injections, while they were higher for single ingredient opioid analgesics (level 4) and surgery (level 6).
Conclusions
There is uncertainty about the benefits and harms of all the interventions reviewed due to the lack of trials conducted in patients with chronic non-specific low back pain without radiculopathy. From the limited trials conducted, non-pharmacological interventions of acupuncture and spinal manipulation provide safer benefits than pharmacological or invasive interventions. However, more research is needed. There were high harms ratings for opioids and surgery.
Registration
This review was registered on the International Prospective Register of Systematic Reviews.
Back pain is a common condition affecting millions of individuals each year. A biopsychosocial approach to back pain provides the best clinical framework. A detailed history and physical examination with a thorough workup are required to exclude emergent or nonoperative etiologies of back pain. The treatment of back pain first uses conventional therapies including lifestyle modifications, nonsteroidal anti-inflammatory drugs, physical therapy, and cognitive behavioral therapy. If these options have been exhausted and pain persists for greater than 6 weeks, imaging and a specialist referral may be indicated.
Chronic pain is often accompanied by negative emotions, and the progression of negative emotions may further impede pain relief. Both chronic pain and negative emotions are closely associated with reward/motivation circuits. Treatment with acupuncture is effective for the relief of pain and emotional disorders, although the acupoint combinations vary. Thus, this study aimed to elucidate the relationship of chronic pain and emotional disorders with the reward/motivation circuits. In association with the theory on “seven emotional factors that cause pain” in traditional Chinese medicine, the potential effect mechanism of “spirit-regulation with acupuncture” for the relief of chronic pain and negative emotions was explored. The findings suggest that chronic pain and its related negative emotions may be effectively relieved with acupuncture after optimizing its acupoint combination based on “spirit-regulation”. However, the role of reward/motivation circuits for negative emotions in the relief of chronic pain with acupuncture needs to be demonstrated.
Background
Along with increasing research on acupuncture for chronic pain, the validity of sham acupuncture (SA) has also been argued.
Methods
Nine databases were searched for randomized controlled trials (RCTs) from the inception date to July 5, 2022. Using Markov Chain Monte Carlo methods, a Bayesian multiple treatment network meta-analysis (NMA) with random-effects model was conducted.
Results
A total of 62 RCTs with 6806 patients and four kinds of treatments (real acupuncture (RA), non-acupuncture (NA), penetrative SA (PSA) and non-penetrative SA (NPSA)) were included. The results indicated that both NPSA and PSA were not superior to NA in improving chronic pain (NPSA: MD -4.77 [95% CI, -11.09 to 1.52]; PSA: MD, -4.96 [95% CI, -10.38 to 0.48]). After combining NPSA and PSA into the SA group, the weak trend of pain relief from SA was still not statistically significant (MD, -4.91 [95% CI, -9.93 to 0.05]). NPSA and PSA had similar effects (MD, 0.18 [95% CI, -5.45 to 5.81]). RA was significantly associated with pain relief, compared with NPSA and PSA (NPSA: MD, -12.03 [95% CI, -16.62 to -7.41]; PSA: MD, -11.85 [95% CI, -15.48 to -8.23]). The results were generally consistent regardless of pain phenotype, frequency, duration, acupuncture methods, analgesic intake, or detection bias.
Conclusion
These results suggested that acupuncture was significantly associated with reduced chronic pain. The two kinds of placebo acupuncture, NPSA and PSA, have similar effects. Both NPSA and PSA, with a weak but not significant effect, are appropriate to be inert placebo controls in RCTs for chronic pain.
Background
This Bayesian network meta-analysis investigated the available randomized control trials (RCTs) to point out which acupuncture protocol is the most effective for chronic aspecific low back pain (LBP). Efficacy was measured in terms of pain (Visual Analogic Scale, VAS) and disability (Roland Morris Disability Questionnaire, RMQ), Transcutaneous Electrical Nerve Stimulation (TENS).
Methods
PubMed, Google scholar, Embase, and Scopus were accessed in March 2022. All the RCTs comparing two or more acupuncture modalities for aspecific chronic LBP were accessed. Only studies which investigated the efficacy of acupuncture on patients with symptoms lasting a minimum of 1.5 months, or with at least three episodes in the previous 12 months, were considered eligible. The Review Manager Software (The Nordic Cochrane Collaboration, Copenhagen) was used for the methodological quality assessment. The STATA Software/MP, Version 14.1 (StataCorporation, College Station, Texas, USA), was used for the statistical analyses. The NMA was performed through the STATA routine for Bayesian hierarchical random-effects model analysis.
Results
Data from 44 RCTs (8338 procedures) were retrieved. 56% of patients were women. The mean age of the patients was 48 ± 10.6 years. The mean BMI was 26.3 ± 2.2 kg/m ² . The individual group (95% confidence interval (CI) 2.02, 7.98) and the standard combined with TENS (95% CI 2.03, 7.97) demonstrated the highest improvement of the RMQ. The VAS score was lower in the standard combined with TENS group (95% CI 3.28, 4.56). Considering the standard acupuncture group, different studies used similar protocols and acupuncture points and the results could thus be compared. The equation for global linearity did not find any statistically significant inconsistency in any of the network comparison.
Conclusion
Verum acupuncture is more effective than sham treatment for the non-pharmacological management of LBP. Among the verum protocols, individualized acupuncture and standard acupuncture with TENS were the protocols that resulted in the highest improvement in pain and quality of life.
Level of Evidence
Level I, Bayesian network meta-analysis of RCTs.
Background
Lumbar disc herniation (LDH) is a common and frequently-occurring disease in clinic. Low back pain and sciatica are the presenting symptoms of LDH. To some extent, it can be considered that measures with the capability to improve low back pain or sciatica have the potential to treat LDH. Ma's bamboo-based medicinal moxibustion therapy can effectively reduce the degree of low back pain and has been widely used. Studies of small sample size have seen significant improvement on pain relief.
Methods/design
The trial is a multicenter, randomized, parallel-group, non-inferiority study. Three hundred and twelve patients will be randomly assigned to a Ma's bamboo-based medicinal moxibustion group (n=156) and an acupuncture group (n=156).Patients in each group will receive treatment every day,6 times a week, 12 times in total. Follow-up will be conducted 14 days after treatment. The primary outcome will be the visual analogue scale(VAS)at baseline, after 6 times of treatment,the end of treatment, and follow-up. the secondary outcomes will include Oswestry disability indexes (ODI) ,modified Japanese Orthopaedic Association low back pain (M-JOA) score,serum β-endorphin (β-EP) and serum substance P (SP). β-EP and SP as well as safety evaluation indexes (routine blood test, liver and kidney function, and ECG) will be measure at baseline and after the end of treatment.
Discussion
The results of the trial will compare the efficacy on low back pain in LDH between Ma's bamboo-based medicinal moxibustion group and acupuncture group and will be expected to make a systematic and objective evaluation on the clinical efficacy and safety of Ma's bamboo-based medicinal moxibustion therapy.
Trial registration
ChiCTR, ChiCTR2000038725. Registered on 29 September 2020.
Introduction: The objective of this study was to understand the experiences of nonpharmacologic therapy (NPT) providers implementing the Oregon Back Pain Policy (OBPP). The Medicaid OBPP expanded coverage of evidence-based NPTs for back pain and simultaneously restricted access to acute and chronic opioid therapy and some interventional approaches for chronic back pain. Materials and Methods: This study uses a cross-sectional, observational design. The authors conducted three online focus groups with 44 credentialed NPT providers in February 2020. Qualitative data analysis was conducted by a multidisciplinary team with an immersion/crystallization approach. Results: Four themes emerged from the data. Participants reported: (1) a lack of direct communication about the policy and mixed levels of understanding of the policy, (2) belief that expanding access to NPT and restricting opioids was beneficial for patients, (3) implementation challenges that compromised access and the perceived effectiveness of care, and (4) financial challenges in accepting Medicaid referrals, due to reimbursement and administrative burden. Conclusion: The goal of the OBPP was to increase access to evidence-based back pain care, including new coverage of NPT services and decreased opioid prescribing for back pain. This study revealed that although many NPT providers support the goals of this policy, the policy was not communicated systematically to providers and was hampered by implementation challenges.
Objective
To provide an update on the evidence of the effectiveness of acupuncture in treating chronic non-specific low back pain (CNSLBP) based on randomized controlled trials (RCTs) of acupuncture for CNSLBP published between 2006 and 2020.MethodsA comprehensive literature search was conducted through the University of Malta website, using the HyDi search engine. The ‘Advanced Search’ option was chosen in order to search for articles that were published in English, and associated with the key words, ‘Chronic’, ‘Acupuncture’, ‘Needle’, ‘Needling’, ‘Non-specific’ and ‘Low Back Pain’, which were entered in their ‘Subject’ field, from the year 2006 till 2020. A comprehensive reading and analysis was done for the search result.ResultsThrough the use of the HyDi search engine, accessible through the University of Malta, eighteen randomized controlled trials that met the criteria of this study were selected.Conclusion
Through the analysis and comparison of the studies selected for this literature review, there is evidence providing that acupuncture is significantly more effective than current conservative treatment modalities for patients with CNSLBP in reducing pain and improving function.
Acupuncture is a promising treatment for relieving pain and improving lower back function in clinical practice. However, evidence from randomized clinical trials (RCTs) remains controversial. Most RCTs conclude that acupuncture procedures for chronic low back pain (CLBP) had no significant difference in efficacy and belonged to placebo. We carefully reviewed and analyzed the methodology and implementation of sham acupuncture in RCTs. Controversial evidence of acupuncture for CLBP is only a microcosm of the evaluation methodological limitation of acupuncture. Inappropriate selection of sham acupuncture controls, rigorous RCT research models, and incorrect interpretation of results may contribute to negative evidence. Evaluating and disregarding the holistic efficacy of acupuncture with an explanatory RCT model based on evaluation drugs may be unwise. Moreover, sham acupuncture is often proven to be non-inert, unreasonable, and with low fidelity. Pitfalls of the explanatory RCT model and sham acupuncture design should be avoided. Establishing a new evaluation system that is in line with the clinical characteristics of acupuncture and obtaining high-quality evidence are difficult but promising tasks.
Background:
Chronic nonspecific low back pain (LBP) is very common; it is defined as pain without a recognizable etiology that lasts for more than three months. Some clinical practice guidelines suggest that acupuncture can offer an effective alternative therapy. This review is a split from an earlier Cochrane review and it focuses on chronic LBP.
Objectives:
To assess the effects of acupuncture compared to sham intervention, no treatment, or usual care for chronic nonspecific LBP.
Search methods:
We searched CENTRAL, MEDLINE, Embase, CINAHL, two Chinese databases, and two trial registers to 29 August 2019 without restrictions on language or publication status. We also screened reference lists and LBP guidelines to identify potentially relevant studies.
Selection criteria:
We included only randomized controlled trials (RCTs) of acupuncture for chronic nonspecific LBP in adults. We excluded RCTs that investigated LBP with a specific etiology. We included trials comparing acupuncture with sham intervention, no treatment, and usual care. The primary outcomes were pain, back-specific functional status, and quality of life; the secondary outcomes were pain-related disability, global assessment, or adverse events.
Data collection and analysis:
Two review authors independently screened the studies, assessed the risk of bias and extracted the data. We meta-analyzed data that were clinically homogeneous using a random-effects model in Review Manager 5.3. Otherwise, we reported the data qualitatively. We used the GRADE approach to assess the certainty of the evidence.
Main results:
We included 33 studies (37 articles) with 8270 participants. The majority of studies were carried out in Europe, Asia, North and South America. Seven studies (5572 participants) conducted in Germany accounted for 67% of the participants. Sixteen trials compared acupuncture with sham intervention, usual care, or no treatment. Most studies had high risk of performance bias due to lack of blinding of the acupuncturist. A few studies were found to have high risk of detection, attrition, reporting or selection bias. We found low-certainty evidence (seven trials, 1403 participants) that acupuncture may relieve pain in the immediate term (up to seven days) compared to sham intervention (mean difference (MD) -9.22, 95% confidence interval (CI) -13.82 to -4.61, visual analogue scale (VAS) 0-100). The difference did not meet the clinically important threshold of 15 points or 30% relative change. Very low-certainty evidence from five trials (1481 participants) showed that acupuncture was not more effective than sham in improving back-specific function in the immediate term (standardized mean difference (SMD) -0.16, 95% CI -0.38 to 0.06; corresponding to the Hannover Function Ability Questionnaire (HFAQ, 0 to 100, higher values better) change (MD 3.33 points; 95% CI -1.25 to 7.90)). Three trials (1068 participants) yielded low-certainty evidence that acupuncture seemed not to be more effective clinically in the short term for quality of life (SMD 0.24, 95% CI 0.03 to 0.45; corresponding to the physical 12-item Short Form Health Survey (SF-12, 0-100, higher values better) change (MD 2.33 points; 95% CI 0.29 to 4.37)). The reasons for downgrading the certainty of the evidence to either low to very low were risk of bias, inconsistency, and imprecision. We found moderate-certainty evidence that acupuncture produced greater and clinically important pain relief (MD -20.32, 95% CI -24.50 to -16.14; four trials, 366 participants; (VAS, 0 to 100), and improved back function (SMD -0.53, 95% CI -0.73 to -0.34; five trials, 2960 participants; corresponding to the HFAQ change (MD 11.50 points; 95% CI 7.38 to 15.84)) in the immediate term compared to no treatment. The evidence was downgraded to moderate certainty due to risk of bias. No studies reported on quality of life in the short term or adverse events. Low-certainty evidence (five trials, 1054 participants) suggested that acupuncture may reduce pain (MD -10.26, 95% CI -17.11 to -3.40; not clinically important on 0 to 100 VAS), and improve back-specific function immediately after treatment (SMD: -0.47; 95% CI: -0.77 to -0.17; five trials, 1381 participants; corresponding to the HFAQ change (MD 9.78 points, 95% CI 3.54 to 16.02)) compared to usual care. Moderate-certainty evidence from one trial (731 participants) found that acupuncture was more effective in improving physical quality of life (MD 4.20, 95% CI 2.82 to 5.58) but not mental quality of life in the short term (MD 1.90, 95% CI 0.25 to 3.55). The certainty of evidence was downgraded to moderate to low because of risk of bias, inconsistency, and imprecision. Low-certainty evidence suggested a similar incidence of adverse events immediately after treatment in the acupuncture and sham intervention groups (four trials, 465 participants) (RR 0.68 95% CI 0.46 to 1.01), and the acupuncture and usual care groups (one trial, 74 participants) (RR 3.34, 95% CI 0.36 to 30.68). The certainty of the evidence was downgraded due to risk of bias and imprecision. No trial reported adverse events for acupuncture when compared to no treatment. The most commonly reported adverse events in the acupuncture groups were insertion point pain, bruising, hematoma, bleeding, worsening of LBP, and pain other than LBP (pain in leg and shoulder).
Authors' conclusions:
We found that acupuncture may not play a more clinically meaningful role than sham in relieving pain immediately after treatment or in improving quality of life in the short term, and acupuncture possibly did not improve back function compared to sham in the immediate term. However, acupuncture was more effective than no treatment in improving pain and function in the immediate term. Trials with usual care as the control showed acupuncture may not reduce pain clinically, but the therapy may improve function immediately after sessions as well as physical but not mental quality of life in the short term. The evidence was downgraded to moderate to very low-certainty considering most of studies had high risk of bias, inconsistency, and small sample size introducing imprecision. The decision to use acupuncture to treat chronic low back pain might depend on the availability, cost and patient's preferences.
Chronic pain reduces life quality and is an important clinical problem associated with emotional and cognitive dysfunction. Epigenetic regulation of DNA methylation is involved in the induction of abnormal behaviors and pathological gene expression. We examined whether acupuncture can restore epigenetic changes caused by chronic pain, and identified the underlying mechanisms in neuropathic pain mice. Acupuncture treatment for 6 months (3 days/week) improved mechanical/cold allodynia and the emotional/cognitive dysfunction caused by left partial sciatic nerve ligation (PSNL)-induced neuropathic pain. The effects of acupuncture were associated with global DNA methylation recovery in the prefrontal cortex (PFC). Analysis of DNA methylation patterns in PFC indicated that 1,364 overlapping genes among 4,442 and 4,416 methylated genes in the PSNL vs. sham and PSNL vs. AP groups, respectively, were highly associated with the DNA methylation process. Acupuncture restored the reduced expression of 5-methylcytosine, methyl-CpG binding protein 2, and DNA methyltransferase family enzymes induced by PSNL in PFC. Methylation levels of Nr4a1 and Chkb associated with mitochondrial dysfunction were decreased in PFC of the PSNL mice, and increased by acupuncture. In contrast, high expression of Nr4a1 and Chkb mRNA in PSNL mice decreased after acupuncture. We also found that acupuncture inhibited the expression of Ras pathway-related genes such as Rasgrp1 and Rassf1. Finally, the expression of Nr4a1, Rasgrp1, Rassf1, and Chkb mRNA increased in the neuronal cells treated with Mecp2 siRNA. These results suggest that acupuncture can relieve chronic pain-induced comorbid conditions by altering DNA methylation of Nr4a1, Rasgrp1, Rassf1, and Chkb in the PFC.
Ethnopharmacological relevance
Intervertebral disc degeneration (IDD) is one of the most common causes of chronic low back pain that spending a lot of workforces and financial resources, seriously affecting human physical and mental health. Clinically used drug treatments and surgical treatments cannot fundamentally relieve the disease and have a risk of recurrence. Traditional Chinese Medicine (TCM) has a history of more than a thousand years in the prevention and treatment of IDD. However, so far, there are few reviews on the treatment of IDD by TCM. Therefore, it is crucial and necessary to systematically mine the existing literature on the treatment of IDD with TCM. This paper strives to systematically describe the modern medicine and TCM theoretical research on IDD, progress in the treatment of IDD and focuses on the treatment of IDD by TCM. which would lay some theoretical foundation and provide new directions for future research.
Materials and methods
Information on clinical observations, animal experiments and relevant pharmacology data about the treatment of IDD were gathered from various sources including traditional Chinese books and Chinese Pharmacopoeia, scientific databases (Elsevier, PubMed, Science Direct, Baidu Scholar, CNKI, Spring Link, Web of Science) and from different professional websites.
Results
This review mainly introduces the current research on the theoretical research on IDD, the combination principle of the TCM formula, and the underlying mechanism of the formula and active ingredients.
Conclusions
At present, domestic and foreign scholars have carried out a lot of research in different ways, such as the molecular mechanism and predisposing factors of IDD, which provides theoretical development and clinical practice significance for future research. TCM, as a multi-component and multi-targeted drug, can produce synergistic effects to exert its efficacy. Therefore, the development of TCM with more specific functions and practical data will not only become a significant trend in the world market but also has an irreplaceable role in the future treatment of IDD.
The "Japanese Orthopaedic Association (JOA) Clinical Practice Guidelines on the Management of Low Back Pain 2019, 2nd Edition" was published in May, 2019. We found multiple issues of serious misinformation on acupuncture; these included, but are not limited to inappropriate conclusions due to errors in literature selection, data extraction and data input. Accordingly we point out each error and provide the correct information. 1. A published paper of meta-analysis of randomized controlled trials (RCTs) on Japanese acupuncture for low back pain in Japanese patients is ignored. 2. Regarding acupuncture for acute low back pain, some RCT data has been incorrectly inputted and analyzed. The wrong numbers have been mistakenly inserted into the analysis software (plus instead of minus) leading to the opposite and incorrect conclusion that acupuncture is not superior to the control group. Furthermore, in a meta-analysis on the effect of acupuncture on functional disorder, data on pain are incorrectly inputted and analyzed. 3. The Guidelines' meta-analysis on acupuncture for chronic low back pain included five RCT papers. The papers included acupuncture (1 article), auricular point acupressure (2 articles), laser acupuncture (1 article) and acupressure backrest (1 article). Only one article in the meta-analysis used needle-inserting acupuncture, therefore, this is not a meta-analysis on acupuncture. There are also many errors in data input. Moreover, there is mislabeling of the forest plot figures: Figure 7 is incorrectly labelled "pain", but actually shows data on "functional disorder" (Figure 8), and vice versa. 4. A published paper of meta-analysis on the cost-effectiveness of acupuncture is ignored. Additionally, although a paper of "meta-analysis on the health economic effects of yoga" is cited, the health economic effects of yoga are not actually addressed or mentioned in that paper. Although the Guidelines state they have fully complied with "Minds Manual for Guideline Development 2014" (Minds: Medical Information Network Distribution Service, Japan Council for Quality Health Care), they did not set up a systematic review team, and do not state whether or not they organized an external review committee. Such circumstances may have contributed to the serious errors in the Guidelines. Because we have also recognized many errors regarding other therapies addressed in the Guidelines, we fear that the present Guidelines may destroy the credibility of the entire clinical practice guidelines published in Japan. We strongly hope that a corrected and revised version is published as soon as possible.
Objective:
To assess the effectiveness of acupuncture for non-specific low back pain (NSLBP) through systematic review of published randomised controlled trials (RCTs).
Methods:
Studies were identified in electronic databases from their inception to February 2018, and were grouped according to the control interventions. The outcomes of interest were pain intensity and disability. Methodological quality was evaluated using the Cochrane risk-of-bias criteria and the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) checklist. The review was reported according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines.
Results:
25 trials (n=7587 participants) were identified and included in a meta-analysis. The results showed that acupuncture was more effective at inducing pain relief than: no treatment (standardised mean difference (SMD) -0.69, 95% CI -0.99 to -0.38); sham acupuncture in the immediate term (SMD -0.33, 95% CI -0.49 to -0.18), short term (SMD -0.47, 95% CI -0.77 to -0.17), and intermediate term (SMD -0.17, 95% CI -0.28 to -0.05); and usual care in the short term (SMD -1.07, 95% CI -1.81 to -0.33) and intermediate term (SMD -0.43, 95% CI -0.77 to -0.10). Also, adjunctive acupuncture with usual care was more effective than usual care alone at all time points studied. With regard to functional improvement, the analysis showed a significant difference between acupuncture and no treatment (SMD -0.94, 95% CI -1.57 to -0.30), whereas the other control therapies could not be assessed.
Conclusion:
We draw a cautious conclusion that acupuncture appears to be effective for NSLBP and that acupuncture may be an important supplement to usual care in the management of NSLBP.
Background context
The North American Spine Society's (NASS) Evidence Based Clinical Guideline for the Diagnosis and Treatment of Low Back Pain features evidence-based recommendations for diagnosing and treating adult patients with nonspecific low back pain. The guideline is intended to reflect contemporary treatment concepts for nonspecific low back pain as reflected in the highest quality clinical literature available on this subject as of February 2016.
PURPOSE
The purpose of the guideline is to provide an evidence-based educational tool to assist spine specialists when making clinical decisions for adult patients with nonspecific low back pain. This article provides a brief summary of the evidence-based guideline recommendations for diagnosing and treating patients with this condition.
Study design
This is a guideline summary review.
Methods
This guideline is the product of the Low Back Pain Work Group of NASS’ Evidence-Based Clinical Guideline Development Committee. The methods used to develop this guideline are detailed in the complete guideline and technical report available on the NASS website. In brief, a multidisciplinary work group of spine care specialists convened to identify clinical questions to address in the guideline. The literature search strategy was developed in consultation with medical librarians. Upon completion of the systematic literature search, evidence relevant to the clinical questions posed in the guideline was reviewed. Work group members utilized NASS evidentiary table templates to summarize study conclusions, identify study strengths and weaknesses, and assign levels of evidence. Work group members participated in webcasts and in-person recommendation meetings to update and formulate evidence-based recommendations and incorporate expert opinion when necessary. The draft guideline was submitted to an internal and external peer review process and ultimately approved by the NASS Board of Directors.
Results
Eighty-two clinical questions were addressed, and the answers are summarized in this article. The respective recommendations were graded according to the levels of evidence of the supporting literature.
Conclusions
The evidence-based clinical guideline has been created using techniques of evidence-based medicine and best available evidence to aid practitioners in the diagnosis and treatment of adult patients with nonspecific low back pain. The entire guideline document, including the evidentiary tables, literature search parameters, literature attrition flowchart, suggestions for future research, and all of the references, is available electronically on the NASS website at https://www.spine.org/ResearchClinicalCare/QualityImprovement/ClinicalGuidelines.aspx
Integrative medicine combines conventional medicine with select practices from complementary and alternative medicine (CAM), for which there is growing high-quality, scientific evidence for their safety and efficacy to manage numerous medical conditions, including acute and chronic pain. Chronic pain is a leading indication for the use of CAM, which offers a multimodal approach to treat the multifaceted nature of pain with minimal complications. Among various CAMs, acupuncture has been the most studied, with clinical evidence from randomized, controlled trials (RCTs) demonstrating its benefit for conditions that most commonly lead patients to present to a Pain Clinic, including low back pain, neck and shoulder pain, headache, and a variety of other chronic pain disorders. The mechanisms of action of acupuncture remain incompletely understood; however, studies continue to elucidate its physiologic effects as well as evaluate its effectiveness for managing painful clinical conditions. With their utility for managing pain with minimal adverse effects compared to pharmacologic therapy, CAMs such as acupuncture provide a powerful tool to address the current overuse and abuse of opioid medications.
Background
Electroacupuncture (EA) has been shown to improve complete spontaneous bowel movements (CSBMs), but the duration of its effects remains unknown. The objective of this study was to explore the duration of acupuncture effects after treatment and its associated factors for chronic severe functional constipation (CSFC).
Methods
This was a secondary analysis of a multicenter, randomized, sham-acupuncture (SA) controlled trial that included 1075 participants with CSFC. The primary outcome, the duration of acupuncture effects after treatment, was the number of weeks during the 12-week follow-up period that participants were to meet the weekly CSBM responder criteria. A weekly CSBM responder was defined as a participant who had at least three CSBMs for a given week and an increase from baseline of at least one CSBM for that same week. We performed a retrospective multivariate analysis to explore potential factors associated with sustained acupuncture effects.
Results
The duration of acupuncture effects in the EA group (5.5 weeks) was significantly higher than the duration of SA effects in the SA group (2.2 weeks) with a between-group difference of 3.2 weeks (95% CI, 2.77–3.78; p < 0.001). A younger age and higher baseline CSBMs per week [regression coefficient (RC) –0.06, 95% confidence interval (CI) (−0.06 to −0.04); RC 2.43, 95% CI 1.78–3.60; respectively] were associated with longer durations of acupuncture effects.
Conclusions
EA had sustained post-treatment effects for CFSC. A significant association among a younger age, higher baseline CSBMs and sustained acupuncture effects was observed. Further research is needed to confirm the association.
Trial registration
ClinicalTrials.gov (NCT01726504). Registered on 26 August 2012.
Objectives
The objectives of this scoping review were to identify (1) study designs and participant populations, (2) types of specific methodology and (3) common results, conclusions and recommendations from the body of evidence regarding our research question; is there a relationship between sleep posture and spinal symptoms.
Design
Scoping review.
Data sources
PEDro, Embase, Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Medline, ProQuest, PsycINFO, SportDISCUS and grey literature from inception to 10 April 2018.
Data selection
Using a modified Arksey and O’Malley framework, all English language studies in humans that met eligibility criteria using key search terms associated with sleep posture and spinal symptoms were included.
Data extraction
Data were independently extracted by two reviewers and mapped to describe the current state of the literature. Articles meeting the search criteria were critically appraised using the Downs and Black checklist.
Results
From 4186 articles, four articles were identified, of which three were epidemiological and one interventional. All studies examined three or more sleep postures, all measured sleep posture using self-report and one study also used infrared cameras. Two studies examined symptoms arising from the lumbar spine, one the cervical spine and one the whole spine. Waking pain and stiffness were the most common symptoms explored and side lying was generally protective against spinal symptoms.
Conclusions
This scoping review highlights the importance of evaluating sleep posture with respect to waking symptoms and has provided preliminary information regarding relationships between sleep posture and spinal symptoms. However, there were not enough high-quality studies to adequately answer our research question. It is recommended future research consider group sizes and population characteristics to achieve research goals, that a validated measure be used to assess sleep posture, that characteristics and location of spinal symptoms are clearly defined and that the side lying posture is subclassified.
Purpose:
The aim of this study was to evaluate the effects of transcutaneous electrical nerve stimulation at acupuncture points versus trigger points on myofascial pain, moods, and sleep quality.
Design:
A randomized controlled study recruited 64 patients with spinal cord injury with myofascial pain.
Methods:
Outcomes of pain, moods, and sleep quality were measured and analyzed by the generalized estimation equation, analysis of covariance, and paired t test. Transcutaneous electrical nerve stimulation was applied for seven consecutive days at Hegu (LI4) and Daling (PC7) acupuncture points or myofascial trigger points.
Finding:
Significant differences were found in pain intensity from Day 3 forward, after controlling for confounders. Significant within-group differences were found in pain, moods, and sleep quality.
Conclusions:
Transcutaneous electrical nerve stimulation at acupuncture and trigger points effectively improved pain, moods, and sleep quality in patients with spinal cord injury with myofascial pain. Acupuncture points had superior improvement in pain intensity and slight improvement in sleep quality than did trigger points.
Clinical relevance:
Transcutaneous electrical nerve stimulation at acupuncture points could be applied for improving myofascial pain.
A 36-item short-form (SF-36) was constructed to survey health status in the Medical Outcomes Study. The SF-36 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. The survey was constructed for self-administration by persons 14 years of age and older, and for administration by a trained interviewer in person or by telephone. The history of the development of the SF-36, the origin of specific items, and the logic underlying their selection are summarized. The content and features of the SF-36 are compared with the 20-item Medical Outcomes Study short-form.
The current study was carried out to investigate the effect of hypothyroidism on the histological structure of parotid salivary gland of the rat.
Twenty male albino rats, weighing between 130-150 grams, were used which were divided into two groups: control group (A) and an experimental group (B), each containing 10 animals. Group B was rendered hypothyroid by giving methimazole (MMI) as 0.02% solution in drinking water daily for 3 weeks. On day 22nd parotid and thyroid glands were removed, weighed and processed for light microscopy. Salivary gland was fixed in Bouin's solution, H&E and Toluidine blue stains were used for histological examination. Serum T3, T4 and TSH levels were determined by enzyme immunoassay.
In group A, serum concentration of T3, T4 and TSH was 12.58 +/- 3.05 etag/ml, 4.72 +/- 1.20 microg/dl, and 0.25 +/- 0.24 microIU/ml respectively, where as in group B it was 2.14 +/- 1.83 etag/ml, 1.04 +/- 0.44 microg/dl and 1.44 +/- 0.20 microIU/ml respectively. When differences between T3, T4 and TSH of the groups were compared, the p-value was < 0.000, < 0.000, and < 0.000 respectively. Mean thyroid weight significantly increased in group B (44.1 0 +/- 1.66 mg) when compared to that in group A (33.70 +/- 1.56 mg). These findings established the occurrence of hypothyroid state in the experimental group. There was a statistically significant reduction in the parotid gland weight in the animals of the experimental group (38.30 +/- 1.15 mg) when compared to the control group (39.60 +/- 0.84 mg), (p < 0.01). With light microscopy, group A showed a normal structure of parotid salivary gland, whereas multiple histological changes were observed in parotrid gland of the experimental group. Number of mast cells in parotid gland was also significantly higher (p < 0.017) in group B (3.70 +/- 1.11/mm2) than in group A (2.25 +/- 1.34/mm2).
The level of T3, T4 decreased and that of TSH increased in the experimental group when compared with control group; there were also changes in the histological structure of the parotid salivary gland.
Background
Use of acupuncture has widely increased in patients with chronic low back pain. However, the evidence supporting its efficacy remains unclear. In this article, we report the design and the protocol of a multi-center randomized sham-controlled trial to treat chronic low back pain. Our goal is to verify the effect of acupuncture on chronic low back pain.
Methods/Design
This study is a multi-center randomized sham-controlled trial with 2 parallel arms. Participants included in the study met the following criteria: 1) low back pain lasting for at least the last 3 months, 2) a documented ≥ 5 points on a 10 cm visual analog scale for bothersomeness of low back pain at the time of screening and 3) between 18 and 65 years of age. Participants were blinded to the real and sham acupuncture treatments. The real acupuncture treatment group received real acupuncture 2 times a week, during a total of 12 sessions over 6 weeks. The control group received sham acupuncture during the same period. In order to assess the primary and secondary outcome measures, the participants were asked to fill out a questionnaire at the baseline and 6, 8, 12 and 24 weeks after starting the treatments. The primary outcome was measured using the visual analog scale for bothersomeness of low back pain at 8 weeks after the initiation of treatments.
Discussion
The result of this trial (which will be available in 2010) will demonstrate the efficacy of using acupuncture to treat chronic low back pain.
Trial registration
This study is registered with the U.S. National Institutes of Health Clinical Trials registry: NCT00815529
The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision.
To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination.
The new STRICTA checklist, which is an official extension of CONSORT, includes 6 items and 17 subitems. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word ‘controlled’ in STRICTA is replaced by ‘clinical’, to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA checklist, in conjunction with both the main CONSORT statement and extension for non-pharmacological treatment, will raise the quality of reporting of clinical trials of acupuncture.
The purpose of this systematic review was to assess the effects of spinal manipulative therapy (SMT), acupuncture and herbal medicine for chronic non-specific LBP. A comprehensive search was conducted by an experienced librarian from the Cochrane Back Review Group (CBRG) in multiple databases up to December 22, 2008. Randomised controlled trials (RCTs) of adults with chronic non-specific LBP, which evaluated at least one clinically relevant, patient-centred outcome measure were included. Two authors working independently from one another assessed the risk of bias using the criteria recommended by the CBRG and extracted the data. The data were pooled when clinically homogeneous and statistically possible or were otherwise qualitatively described. GRADE was used to determine the quality of the evidence. In total, 35 RCTs (8 SMT, 20 acupuncture, 7 herbal medicine), which examined 8,298 patients, fulfilled the inclusion criteria. Approximately half of these (2 SMT, 8 acupuncture, 7 herbal medicine) were thought to have a low risk of bias. In general, the pooled effects for the studied interventions demonstrated short-term relief or improvement only. The lack of studies with a low-risk of bias, especially in regard to SMT precludes any strong conclusions; however, the principal findings, which are based upon low- to very-low-quality evidence, suggest that SMT does not provide a more clinically beneficial effect compared with sham, passive modalities or any other intervention for treatment of chronic low-back pain. There is evidence, however, that acupuncture provides a short-term clinically relevant effect when compared with a waiting list control or when acupuncture is added to another intervention. Although there are some good results for individual herbal medicines in short-term individual trials, the lack of homogeneity across studies did not allow for a pooled estimate of the effect. In general, these results are in agreement with other recent systematic reviews on SMT, but in contrast with others. These results are also in agreement with recent reviews on acupuncture and herbal medicine. Randomized trials with a low risk of bias and adequate sample sizes are direly needed.
Electronic supplementary material
The online version of this article (doi:10.1007/s00586-010-1356-3) contains supplementary material, which is available to authorized users.
A 36-item short-form (SF-36) was constructed to survey health status in the Medical Outcomes Study. The SF-36 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. The survey was constructed for self-administration by persons 14 years of age and older, and for administration by a trained interviewer in person or by telephone. The history of the development of the SF-36, the origin of specific items, and the logic underlying their selection are summarized. The content and features of the SF-36 are compared with the 20-item Medical Outcomes Study short-form.
Despite growing popularity of complementary and alternative medical (CAM) therapies, little is known about the patients seen by CAM practitioners. Our objective was to describe the patients and problems seen by CAM practitioners.
We collected data on 20 consecutive visits to randomly sampled licensed acupuncturists, chiropractors, massage therapists, and naturopathic physicians practicing in Arizona, Connecticut, Massachusetts, and Washington. Data were collected on patient demographics, smoking status, referral source, reasons for visit, concurrent medical care, payment source, and visit duration. Comparative data for conventional physicians were drawn from the National Ambulatory Medical Care Survey.
In each profession, at least 99 practitioners collected data on more than 1,800 visits. More than 80% of visits to CAM providers were by young and middle-aged adults, and roughly two thirds were by women. Children comprised 10% of visits to naturopathic physicians but only 1% to 4% of all visits to other CAM providers. At least two thirds of visits resulted from self-referrals, and only 4% to 12% of visits were from conventional physician referrals. Chiropractors and massage therapists primarily saw musculoskeletal problems, while acupuncturists and naturopathic physicians saw a broader range of conditions. Visits to acupuncturists and massage therapists lasted about 60 minutes compared with 40 minutes for naturopathic physicians and less than 20 minutes for chiropractors. Most visits to chiropractors and naturopathic physicians, but less than one third of visits to acupuncturists and massage therapists, were covered by insurance.
This information will help inform discussions of the roles CAM practitioners will play in the health care system of the future.
For clinical trials of acupuncture, it would be desirable to have a sham procedure that is indistinguishable from the real treatment, yet inactive. A sham needle has been designed which telescopes instead of penetrating the skin. The Park Sham Device involves an improved method of supporting the sham needle and requires validation. The objective of these studies was to test whether the sham procedure using the new device was 1) indistinguishable from the same procedure using real needles in acupuncture naïve subjects, and 2) inactive, where the specific needle sensation (de qi) is taken as a surrogate measure of activity. The studies were designed as subject and assessor blind, randomised controlled trials. Study 1) included 58 patients enrolled in a clinical trial of acupuncture for acute stroke. Study 2) included 63 healthy, acupuncture naïve, adult volunteers. The interventions used were real or sham acupuncture using the Park Sham Device. Study 1) was set in a district general hospital, and study 2) in a university laboratory. The outcome measure in study 1) was the form of treatment that patients believed they had received. In study 2) the outcome measure was experience of de qi, as judged by three acupuncture experts. No patient in either group(study 1) believed he or she had been treated with the sham needle. In 40 volunteers (study 2) for whom experts achieved consensus, the relative risk of experiencing de qi with real acupuncture to that with sham acupuncture was 15.38 (95% CI 2.26 to 104.86). The inter-rater reliability of all 13 experts (study 2), calculated from their judgements on 10 subjects selected by randomisation, was 0.52 (95% CI 0.19 to 0.61). In conclusion, the results suggest that the procedure using the new device is indistinguishable from the same procedure using real needles in acupuncture naïve subjects, and is inactive, where the specific needle sensation (de qi) is taken as a surrogate measure of activity. It is therefore a valid control for acupuncture trials. The findings also lend support to the existence of de qi, a major concept underlying traditional Chinese acupuncture.
To conduct an exploratory, retrospective study of acupuncture patients' perceptions of practitioner empathy, patient enablement, and health outcome, and to investigate the associations between them.
In a retrospective, observational study, questionnaires were distributed to 192 patients randomly selected from a population of 6348 who, several months previously, had participated in a survey of acupuncture safety, and had agreed to be contacted again. The main measures included patients' perceptions of their practitioners' empathy using the Consultation and Relational Empathy Measure, the Patient Enablement Instrument, and the Glasgow Homeopathic Hospital Outcome Scale (measuring change in main complaint and well-being).
A total of 143 (74%) patients responded (27% men and 73% women) with an average age of 51 years. Comparisons between the population, the sample selected, and the responding sample showed reasonable equivalence. The majority of patients (71%) were in the middle of an ongoing course of treatment at the time of completing the questionnaires for this study. 36% of patients were attending for reasons of "general well-being," 34% for musculoskeletal problems, 11% for emotional or psychological problems, and 19% for other reasons. Empathy and enablement scores were not influenced by age or reason for attendance, but men showed significantly lower scores than women (p < 0.05). Patient enablement was significantly positively correlated with perception of their practitioners' empathy (Spearman's rho = 0.256, p < 0.01). Enablement in turn was strongly positively correlated with the outcome of both the main complaint (rho = 0.457, p < 0.0001) and improved well-being (rho = 0.521, p < 0.0001).
Patients' perceptions of consultations with their acupuncturists suggest that their experience of empathy is significantly associated with patient enablement, which in turn is highly correlated with improved self-reported health outcomes.
The primary purpose of revalidation is to certify fitness to practise. The Shipman inquiry made recommendations for improving the CMC's revalidation model. The GMC intends to develop explicit requirements for validation and quality assurance. The GMC will also continue to work with others to detect poorly performing doctors and ensure early action.
Acupuncture is widely used by patients with low back pain, although its effectiveness is unclear. We investigated the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with chronic low back pain.
Patients were randomized to treatment with acupuncture, minimal acupuncture (superficial needling at nonacupuncture points), or a waiting list control. Acupuncture and minimal acupuncture were administered by specialized acupuncture physicians in 30 outpatient centers, and consisted of 12 sessions per patient over 8 weeks. Patients completed standardized questionnaires at baseline and at 8, 26, and 52 weeks after randomization. The primary outcome variable was the change in low back pain intensity from baseline to the end of week 8, as determined on a visual analog scale (range, 0-100 mm).
A total of 298 patients (67.8% female; mean +/- SD age, 59 +/- 9 years) were included. Between baseline and week 8, pain intensity decreased by a mean +/- SD of 28.7 +/- 30.3 mm in the acupuncture group, 23.6 +/- 31.0 mm in the minimal acupuncture group, and 6.9 +/- 22.0 mm in the waiting list group. The difference for the acupuncture vs minimal acupuncture group was 5.1 mm (95% confidence interval, -3.7 to 13.9 mm; P = .26), and the difference for the acupuncture vs waiting list group was 21.7 mm (95% confidence interval, 13.9-30.0 mm; P<.001). Also, at 26 (P=.96) and 52 (P=.61) weeks, pain did not differ significantly between the acupuncture and the minimal acupuncture groups.
Acupuncture was more effective in improving pain than no acupuncture treatment in patients with chronic low back pain, whereas there were no significant differences between acupuncture and minimal acupuncture.
Low back pain is a considerable health problem in all developed countries and is most commonly treated in primary healthcare settings. It is usually defined as pain, muscle tension, or stiffness localised below the costal margin and above the inferior gluteal folds, with or without leg pain (sciatica). The most important symptoms of non-specific low back pain are pain and disability. The diagnostic and therapeutic management of patients with low back pain has long been characterised by considerable variation within and between countries among general practitioners, medical specialists, and other healthcare professionals.1 2 w1 Recently, a large number of randomised clinical trials have been done, systematic reviews have been written, and clinical guidelines have become available. The outlook for evidence based management of low back pain has greatly improved. This review presents the current state of science regarding the diagnosis and treatment of low back pain.
We used the Cochrane Library to identify relevant systematic reviews that evaluate the effectiveness of conservative, complementary, and surgical interventions. Medline searches were used to find other relevant systematic reviews on diagnosis and treatment of low back pain, with the keywords “low back pain”, “systematic review”, “meta-analysis”, “diagnosis”, and “treatment”. Our personal files were used for additional references. We also checked available clinical guidelines and used Clinical Evidence as source for clinically relevant information on benefits and harms of treatments.3 4
Most of us will experience at least one episode of low back pain during our life. Reported lifetime prevalence varies from 49% to 70% and point prevalences from 12% to 30% are reported in Western countries.w2 w3
The diagnostic process is mainly focused on the triage of patients with specific or non-specific low back pain. Specific low back pain is defined as symptoms caused by a specific pathophysiological mechanism, such …
Many English language words have been used to describe the acupuncture needle sensation known as de qi, words such as dull, aching, and spreading. However, there is little agreement on which actual words are acceptable as descriptors. In experimental trials of acupuncture in which the needle sensation is an important variable, a quantitative measure is needed to monitor and control for variability in de qi.
An established scale in the literature provides a list of 25 sensations associated with acupuncture needling that patients might experience. An international group of acupuncture experts rated these 25 sensations in two categories: those predominantly associated with de qi and those with acute pain at the site of needling. For each category, sensations were classified into hierarchic clusters, one for de qi and one for acute pain, and the results were presented in dendrograms.
Twenty-nine international experts were invited to participate; 22 (76%) responded and 20 completed the questionnaire. On average, they had 21 years' experience in acupuncture practice (range 10-30 years). Seven sensations were found to be in the cluster associated with de qi: aching, dull, heavy, numb, radiating, spreading, and tingling. Nine sensations were found to be in a cluster associated with acute pain at the site of needling: burning, hot, hurting, pinching, pricking, sharp, shocking, stinging, and tender. The experts also raised a number of issues regarding the limitations of the questionnaire used, providing useful data for future research.
Data from experienced acupuncturists have been analyzed to provide two separate clusters of sensations associated with acupuncture needling: a de qi cluster and an acute pain cluster. In the design of experimental trials involving acupuncture needling, researchers will find these two clusters of sensations useful for monitoring and controlling for variation in needle sensation.
To determine whether a short course of traditional acupuncture improves longer term outcomes for patients with persistent non-specific low back pain in primary care.
Pragmatic, open, randomised controlled trial.
Three private acupuncture clinics and 18 general practices in York, England.
241 adults aged 18-65 with non-specific low back pain of 4-52 weeks' duration.
10 individualised acupuncture treatments from one of six qualified acupuncturists (160 patients) or usual care only (81 patients).
The primary outcome was SF-36 bodily pain, measured at 12 and 24 months. Other outcomes included reported use of analgesics, scores on the Oswestry pain disability index, safety, and patient satisfaction.
39 general practitioners referred 289 patients of whom 241 were randomised. At 12 months average SF-36 pain scores increased by 33.2 to 64.0 in the acupuncture group and by 27.9 to 58.3 in the control group. Adjusting for baseline score and for any clustering by acupuncturist, the estimated intervention effect was 5.6 points (95% confidence interval -0.2 to 11.4) at 12 months (n = 213) and 8.0 points (2.8 to 13.2) at 24 months (n = 182). The magnitude of the difference between the groups was about 10%-15% of the final pain score in the control group. Functional disability was not improved. No serious or life threatening events were reported.
Weak evidence was found of an effect of acupuncture on persistent non-specific low back pain at 12 months, but stronger evidence of a small benefit at 24 months. Referral to a qualified traditional acupuncturist for a short course of treatment seems safe and acceptable to patients with low back pain.
ISRCTN80764175 [controlled-trials.com].
The purpose of this study was to examine the immediate effect of single acupuncture stimulation to the most painful point in patients with low back pain.
A randomised, evaluator-blinded, sham controlled clinical trial was conducted in which 31 patients with low back pain were randomly allocated to either an acupuncture group (n = 15) or a sham acupuncture group (n = 16). Both acupuncture and sham acupuncture were performed at the most painful point on the lower back of the subjects. For the acupuncture group, a stainless steel needle was inserted to a depth of 20 mm and manually stimulated (sparrow pecking method) for 20 seconds, while for the sham treatment a guide tube without a needle was placed at the point and tapped on the skin. Changes in low back pain were evaluated with a visual analogue scale (VAS) and the Schober test. Participants were also asked if they felt the needling sensation or not. The therapy and the evaluation were independently performed by two different acupuncturists.
VAS score and the Schober test score showed significant improvement after treatment as compared with the sham group (P = 0.02, 0.001, respectively). There were no significant differences in the needling sensation between the acupuncture and sham group.
These results suggest that acupuncture at the most painful point gives immediate relief of low back pain.
Disability questionnaires are used for clinical assessment, outcome measurement, and research methodology. Any disability measurement must be adapted culturally for comparability of data, when the patients, who are measured, use different languages. This study aimed to conduct cross-cultural adaptation in translating the original (English) version of the Oswestry Disability Index (ODI) into Korean, and then to assess the reliability of the Korean versions of the Oswestry Disability Index (KODI). We used methodology to obtain semantic, idiomatic, experimental, and conceptual equivalences for the process of cross-cultural adaptation. The KODI were tested in 116 patients with chronic low back pain. The internal consistency and reliability for the KODI reached 0.9168 (Cronbach's alpha). The test-retest reliability was assessed with 32 patients (who were not included in the assessment of Cronbach's alpha) over a time interval of 4 days. Test-retest correlation reliability was 0.9332. The entire process and the results of this study were reported to the developer (Dr. Fairbank JC), who appraised the KODI. There is little evidence of differential item functioning in KODI. The results suggest that the KODI is internally consistent and reliable. Therefore, the KODI can be recommended as a low back pain assessment tool in Korea.
To our knowledge, verum acupuncture has never been directly compared with sham acupuncture and guideline-based conventional therapy in patients with chronic low back pain.
A patient- and observer-blinded randomized controlled trial conducted in Germany involving 340 outpatient practices, including 1162 patients aged 18 to 86 years (mean +/- SD age, 50 +/- 15 years) with a history of chronic low back pain for a mean of 8 years. Patients underwent ten 30-minute sessions, generally 2 sessions per week, of verum acupuncture (n = 387) according to principles of traditional Chinese medicine; sham acupuncture (n = 387) consisting of superficial needling at nonacupuncture points; or conventional therapy, a combination of drugs, physical therapy, and exercise (n = 388). Five additional sessions were offered to patients who had a partial response to treatment (10%-50% reduction in pain intensity). Primary outcome was response after 6 months, defined as 33% improvement or better on 3 pain-related items on the Von Korff Chronic Pain Grade Scale questionnaire or 12% improvement or better on the back-specific Hanover Functional Ability Questionnaire. Patients who were unblinded or had recourse to other than permitted concomitant therapies during follow-up were classified as nonresponders regardless of symptom improvement.
At 6 months, response rate was 47.6% in the verum acupuncture group, 44.2% in the sham acupuncture group, and 27.4% in the conventional therapy group. Differences among groups were as follows: verum vs sham, 3.4% (95% confidence interval, -3.7% to 10.3%; P = .39); verum vs conventional therapy, 20.2% (95% confidence interval, 13.4% to 26.7%; P < .001); and sham vs conventional therapy, 16.8% (95% confidence interval, 10.1% to 23.4%; P < .001.
Low back pain improved after acupuncture treatment for at least 6 months. Effectiveness of acupuncture, either verum or sham, was almost twice that of conventional therapy.
The difference between superficial and deep needling at acupuncture points has yet to be mapped with functional magnetic resonance imaging (fMRI). Using a 3T MRI, echo planar imaging data were acquired for 17 right-handed healthy volunteer participants. Two fMRI scans of acupuncture needling were taken in random order in a block design, one for superficial and one for deep needling on the right hand at the acupuncture point LI-4 (Hegu), with the participant blind to the order. For both scans needle stimulation was used. Brain image analysis tools were used to explore within-group and between-group differences in the blood oxygen level dependent (BOLD) responses. The study demonstrated marked similarities in BOLD signal responses between superficial and deep needling, with no significant differences in either activations (increases in BOLD signal) or deactivations (decreases in BOLD signal) above the voxel Z score of 2.3 with corrected cluster significance of P=0.05. For both types of needling, deactivations predominated over activations. These fMRI data suggest that acupuncture needle stimulation at two different depths of needling, superficial and deep, do not elicit significantly different BOLD responses. This data is consistent with the equivalent therapeutic outcomes that are claimed by proponents of Japanese and Chinese styles of acupuncture that utilise superficial and deep needling, respectively.
Background
Acupuncture is commonly used to treat back pain, but there is no published meta-analysis of trials of its effectiveness for this condition.Objective
To perform a meta-analysis of trials of acupuncture for the treatment of back pain.Methods
A systematic literature search was conducted to retrieve all randomized controlled trials of any form of acupuncture for any type of back pain in humans. The adequacy of the acupuncture treatment was assessed by consulting 6 experienced acupuncturists. The main outcome measure for the meta-analysis was numbers of patients whose symptoms were improved at the end of treatment.Results
Twelve studies were included, of which 9 presented data suitable for meta-analysis. The odds ratio of improvement with acupuncture compared with control intervention was 2.30 (95% confidence interval, 1.28-4.13). For sham-controlled, evaluator-blinded studies, the odds ratio was 1.37 (95% confidence interval, 0.84-2.25).Conclusion
Acupuncture was shown to be superior to various control interventions, although there is insufficient evidence to state whether it is superior to placebo.
Study Design. A systematic review of randomized controlled trials. Objectives. To evaluate the efficacy and effectiveness of acupuncture for the management of nonspecific low back pain. Summary of Background Data. Acupuncture is one of the oldest forms of therapy, but little is known about the effectiveness of acupuncture for low back pain. Methods. Randomized controlled trials were done to assess the effectiveness of all types of acupuncture treatment, which involves needling for subjects with nonspecific low back pain. Two reviewers blinded with respect to authors, institution, and journal independently assessed the methodologic quality of the studies. Because data were statistically and clinically too heterogeneous, a qualitative review was performed. The evidence was classified into four levels: strong, moderate, limited, or no evidence. Results. Eleven randomized controlled trials were included. Overall, the methodologic quality was low. Only two studies met the preset “high quality” level for this review. No study clearly evaluated acupuncture for acute low back pain. The results indicate that there was no evidence showing acupuncture to be more effective than no treatment. There was moderate evidence indicating that acupuncture is not more effective than trigger‐point injection or transcutaneous electrical nerve stimulation, and there was limited evidence that acupuncture is not more effective than placebo or sham acupuncture for the management of chronic low back pain. Conclusions. Because this systematic review did not clearly indicate that acupuncture is effective in the management of back pain, the authors would not recommend acupuncture as a regular treatment for patients with low back pain. There clearly is a need for more high‐quality randomized controlled trials.
Controversy remains regarding the mechanisms of acupuncture analgesia. A prevailing theory, largely unproven in humans, is that it involves the activation of endogenous opioid antinociceptive systems and μ-opioid receptors (MORs). This is also a neurotransmitter system that mediates the effects of placebo-induced analgesia. This overlap in potential mechanisms may explain the lack of differentiation between traditional acupuncture and either non-traditional or sham acupuncture in multiple controlled clinical trials. We compared both short- and long-term effects of traditional Chinese acupuncture (TA) versus sham acupuncture (SA) treatment on in vivo MOR binding availability in chronic pain patients diagnosed with fibromyalgia (FM). Patients were randomized to receive either TA or SA treatment over the course of 4 weeks. Positron emission tomography (PET) with 11C-carfentanil was performed once during the first treatment session and then repeated a month later following the eighth treatment. Acupuncture therapy evoked short-term increases in MOR binding potential, in multiple pain and sensory processing regions including the cingulate (dorsal and subgenual), insula, caudate, thalamus, and amygdala. Acupuncture therapy also evoked long-term increases in MOR binding potential in some of the same structures including the cingulate (dorsal and perigenual), caudate, and amygdala. These short- and long-term effects were absent in the sham group where small reductions were observed, an effect more consistent with previous placebo PET studies. Long-term increases in MOR BP following TA were also associated with greater reductions in clinical pain. These findings suggest that divergent MOR processes may mediate clinically relevant analgesic effects for acupuncture and sham acupuncture.
Objective
To discuss the concepts of the minimal clinically important difference (MCID) and the smallest detectable difference (SDD) and to examine their relation to required sample sizes for future studies using concrete data of the condition-specific Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the generic Medical Outcomes Study 36-Item Short Form (SF-36) in patients with osteoarthritis of the lower extremities undergoing a comprehensive inpatient rehabilitation intervention.MethodsSDD and MCID were determined in a prospective study of 122 patients before a comprehensive inpatient rehabilitation intervention and at the 3-month followup. MCID was assessed by the transition method. Required SDD and sample sizes were determined by applying normal approximation and taking into account the calculation of power.ResultsIn the WOMAC sections the SDD and MCID ranged from 0.51 to 1.33 points (scale 0 to 10), and in the SF-36 sections the SDD and MCID ranged from 2.0 to 7.8 points (scale 0 to 100). Both questionnaires showed 2 moderately responsive sections that led to required sample sizes of 40 to 325 per treatment arm for a clinical study with unpaired data or total for paired followup data.Conclusion
In rehabilitation intervention, effects larger than 12% of baseline score (6% of maximal score) can be attained and detected as MCID by the transition method in both the WOMAC and the SF-36. Effects of this size lead to reasonable sample sizes for future studies lying below n = 300. The same holds true for moderately responsive questionnaire sections with effect sizes higher than 0.25. When designing studies, assumed effects below the MCID may be detectable but are clinically meaningless.
The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group, and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an official extension of CONSORT, includes six items and 17 sub-items. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background, and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word “controlled” in STRICTA is replaced by “clinical,” to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA, in conjunction with both the main CONSORT Statement and extension for nonpharmacologic treatment, will raise the quality of reporting of clinical trials of acupuncture.