Acupuncture for acute non-specific low back pain: A pilot randomised non-penetrating sham controlled trial

Health and Rehabilitation Sciences Research Institute, School of Health Sciences, University of Ulster, Northern Ireland, United Kingdom.
Complementary Therapies in Medicine (Impact Factor: 1.55). 07/2008; 16(3):139-46. DOI: 10.1016/j.ctim.2007.03.001
Source: PubMed


A pilot study to assess the feasibility of a trial to investigate the efficacy of acupuncture compared to placebo needling for the treatment of acute low back pain (LBP). As part of this, the study was designed to establish the credibility of the placebo control, and to provide data to inform a power analysis to determine numbers for a future trial.
A pilot patient and assessor blinded randomized controlled trial.
Primary care health centre facility, South and East Belfast Trust, Northern Ireland.
Patients from the physiotherapy waiting list (n=48) with LBP of less than 12 weeks duration.
Roland and Morris Disability Questionnaire (RMDQ), Visual Analogue Scale (VAS), medication use and an exit questionnaire were completed at baseline, end of treatment, and at 3 months follow up.
Ninety-four percent (45/48) of patients completed assigned treatment, 83% (40/48) completed 3 months follow-up. The sham needle used here proved to be credible: 91.7% in the placebo group believed they had received acupuncture, compared to 95.8% in the verum acupuncture group. Differences in baseline characteristics were accounted for using ANCOVA. There was no significant difference between groups on the RMDQ over time. For pain, the only statistically significant difference was at the 3 months follow up (worst VAS, point estimate, 18.7, 95% CI 1.5-36.0, p=0.034). The majority of patients were taking some form of analgesic medication for LBP at the start of treatment (n=44; 92%), and at the end of treatment the verum acupuncture group were taking significantly fewer tablets of pain control medication (mean (S.D.): 1.0+/-0.3) than the placebo group (mean (S.D.): 4.2+/-0.6, p<0.05). Based upon these data, power analysis (power=90%, alpha=0.05, minimal clinically important difference (MCID) for RMDQ=2.5 points) indicated that 120 participants (60 per group) would be needed to complete an adequately powered randomized controlled trial.
This study has demonstrated the feasibility of a randomized controlled trial of penetrating needle acupuncture compared to a non-penetrating sham for the treatment of acute LBP in primary care; 120 participants would be required in a fully powered trial. The placebo needle used in this study proved to be a credible form of control.

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    • "Sham acupuncture will be applied to the same nine acupuncture points as in the standard acupuncture group. This Parksham acupuncture device has been used in several previous clinical research studies [28-30]. "
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    ABSTRACT: Acupuncture is an effective yet complex therapy, integrating syndrome differentiation, selection of appropriate acupoints and skillful needling techniques. Clinicians carefully tailor acupuncture treatment to each patient. However, most clinical trials of acupuncture have been based on a standardized formula of points for every patient without properly accounting for individualdifferences and, as a result, have not been reflective of the true efficacy of clinical practice. To determine the efficacy of meridian-based syndrome differentiation and Sa-am acupuncture, we have designed a simple pragmatic trial providing individualized treatments while working within a general framework. The study is designed to be a parallel, patient- and assessor-blind, randomized controlled trial (RCT). A total of250 patients with knee osteoarthritis (OA) will be recruited from two independent hospitals, Semyung University Oriental Medicine Hospital in Chung-ju and Dongguk University Oriental Hospital in Ilsan, South Korea. Patients will be randomly allocated into four treatment groups: 1. individualized, meridian-based syndrome differentiation and Sa-am acupuncture treatment;2. standard acupuncture treatment;3. sham acupuncture treatment; and 4. no acupuncture treatment. Patients in groups 1 to 3 will be treated by certified oriental medicine doctors twice a week for 6 weeks. The primary outcome measure will be the self-reported total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score change. The trial will also include secondary outcome measures. This trial is designed to determine the efficacy of individualized acupuncture treatment in patients with knee OA by comparing the differences between individualized, standard, sham and no acupuncture treatments. The results of this trial may validate the efficacy of individualized acupuncture therapy, encouraging its widespread use. Trial registration NCT01569230
    Full-text · Article · May 2013 · Trials
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    • "The traditional techniques of acupuncture (penetrating needles at acupoints for different organ systems and deqi) are the verum conditions of most acupuncture studies. Control conditions include penetrating needles at " nonpoints " and " wrong points, " commercially-developed nonpenetrating devices, homemade nonpenetrating needles, and toothpicks or cocktail sticks [6] [7] [8] [9]. " Nonpoints " are points not used for any purpose in traditional acupuncture . "
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    ABSTRACT: Background. There is no agreement among researchers on viable controls for acupuncture treatment, and the assessment of the effectiveness of blinding and its interpretation is rare. Purpose. To systematically assess the effectiveness of blinding (EOB) in reported acupuncture trials; to explore results of RCTs using a quantitative measure of EOB. Data Sources. A systematic review of published sham RCTs that assessed blinding. Study Selection. Five hundred and ninety studies were reviewed, and 54 studies (4783 subjects) were included. Data Extraction. The number of patients who guessed their treatment identity was extracted from each study. Variables with possible influence on blinding were identified. Data Synthesis. The blinding index was calculated for each study. Based on blinding indexes, studies were congregated into one of the nine blinding scenarios. Individual study characteristics were explored for potential association with EOB. Limitations. There is a possibility of publication or reporting bias. Conclusions. The most common scenario was that the subjects believed they received verum acupuncture regardless of the actual treatment received, and overall the subject blinding in the acupuncture studies was satisfactory, with 61% of study participants maintaining ideal blinding. Objectively calculated blinding data may offer meaningful and systematic ways to further interpret the findings of RCTs.
    Full-text · Article · Mar 2013 · Evidence-based Complementary and Alternative Medicine
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    • "It is noteworthy that our data for acute LBP are analogous to those for chronic LBP reported in a large-scale German study, in which, at 6 months, the positive response rate was 47.6% for the TA group, 44.2% for the SA group, and 27.4% for the CT group; the magnitude of the beneficial effect of acupuncture , real or sham, was almost twice that of CT [7]. Similarly, Kennedy et al., in a pilot study that used PA as a control treatment for acute LBP, found no differences between the group treated with acupuncture and the control group, although there was a reduction in demand for analgesic medication [12]. Any type of peripheral sensorial stimulus, including tactile stimulus, is capable of stimulating multimodal receptors of the C-fibre primary afferents, which can modulate the limbic system at the insula and thus reduce the affective component of pain [10]. "
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    ABSTRACT: Reviews of the efficacy of acupuncture as a treatment for acute low back pain have concluded that there is insufficient evidence for its efficacy and that more research is needed to evaluate it. A multicentre randomized controlled trial was conducted at 4 primary-care centres in Spain to evaluate the effects of acupuncture in patients with acute nonspecific low back pain in the context of primary care. A total of 275 patients with nonspecific acute low back pain (diagnosed by their general practitioner) were recruited and assigned randomly to 4 different groups: conventional treatment either alone or complemented by 5 sessions over a 2-week period of true acupuncture, sham acupuncture, or placebo acupuncture per patient. Patients were treated from February 2006 to January 2008. The primary outcome was the reduction in Roland Morris Disability Questionnaire scores of 35% or more after 2weeks' treatment. The patients in the 3 types of acupuncture groups were blinded to the treatments, but those who received conventional treatment alone were not. In the analysis adjusted for the total sample (true acupuncture relative risk 5.04, 95% confidence interval 2.24-11.32; sham acupuncture relative risk 5.02, 95% confidence interval 2.26-11.16; placebo acupuncture relative risk 2.57 95% confidence interval 1.21-5.46), as well as for the subsample of occupationally active patients, all 3 modalities of acupuncture were better than conventional treatment alone, but there was no difference among the 3 acupuncture modalities, which implies that true acupuncture is not better than sham or placebo acupuncture.
    Full-text · Article · Jul 2012 · Pain
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