Prolotherapy Injections, Saline Injections, and Exercises for Chronic Low-Back Pain: A Randomized Trial

University of Queensland, Brisbane, Queensland, Australia
Spine (Impact Factor: 2.3). 01/2004; 29(1):9-16; discussion 16. DOI: 10.1097/01.BRS.0000105529.07222.5B
Source: PubMed


To assess the efficacy of a prolotherapy injection and exercise protocol in the treatment of chronic nonspecific low back pain.
Randomized controlled trial with two-by-two factorial design, triple-blinded for injection status, and single-blinded for exercise status.
General practice.
One hundred ten participants with nonspecific low-back pain of average 14 years duration were randomized to have repeated prolotherapy (20% glucose/0.2% lignocaine) or normal saline injections into tender lumbo-pelvic ligaments and randomized to perform either flexion/extension exercises or normal activity over 6 months.
Pain intensity (VAS) and disability scores (Roland-Morris) at 2.5, 4, 6, 12, and 24 months.
Follow-up was achieved in 96% at 12 months and 80% at 2 years. Ligament injections, with exercises and with normal activity, resulted in significant and sustained reductions in pain and disability throughout the trial, but no attributable effect was found for prolotherapy injections over saline injections or for exercises over normal activity. At 12 months, the proportions achieving more than 50% reduction in pain from baseline by injection group were glucose-lignocaine: 0.46 versus saline: 0.36. By activity group these proportions were exercise: 0.41 versus normal activity: 0.39. Corresponding proportions for >50% reduction in disability were glucose-lignocaine: 0.42 versus saline 0.36 and exercise: 0.36 versus normal activity: 0.38. There were no between group differences in any of the above measures.
In chronic nonspecific low-back pain, significant and sustained reductions in pain and disability occur with ligament injections, irrespective of the solution injected or the concurrent use of exercises.

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Available from: Michael John Yelland, Sep 18, 2014
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    • "By these presumed mechanisms, the hypertonic dextrose solution stimulates the proliferation of chondrocytes, osteocytes , and fibroblasts. These cells then excrete extracellular matrix, which enhances the stability of the joints by tightening and strengthening the ligaments, tendons, and joint stabilizing structures [Rabago et al. 2013b; Yelland et al. 2003; Klein et al. 1993]. "
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    ABSTRACT: Prolotherapy is an injection-based complementary treatment, which has shown promising results in the treatment of different musculoskeletal disorders. The aim of this study was to determine the therapeutic efficacy of dextrose prolotherapy on pain, range of motion, and function in patients with knee osteoarthritis (OA). In this single-arm prospective study, participants with symptomatic moderate knee osteoarthritis underwent prolotherapy with intra-articular injection of 20% dextrose water at baseline, and at 4 weeks and 8 weeks later. Patients were followed for 24 weeks. Pain severity at rest and activity, according to the visual analog scale (VAS), articular range of motion (ROM), and Western Ontario and McMaster Universities arthritis index (WOMAC) scores were measured at baseline, 4, 8, and 24 weeks later. A total of 24 female patients (average age: 58.37 ± 11.8 years old) received 3-monthly injection therapies. Before the treatment, the mean articular range of motion was 105.41 ± 11.22°. Mean VAS scale at rest and activity was 8.83 ± 1.37 and 9.37 ± 1.31, respectively. At the end of week 24, knee ROM increased by 8°. Pain severity in rest and activity decreased to 4.87 ± 1.39, 45.86%, and 44.23%, respectively (p < 0.001). Total WOMAC score and its subcategories showed a continuous improvement trend in all the evaluation sessions, so that at the end of the study, the total score decreased by 30.5 ± 14.27 points (49.58%) (p < 0.001). Improvements of all parameters were considerable until week 8, and were maintained throughout the study period. Prolotherapy with three intra-articular injections of hypertonic dextrose given 4 weeks apart for selected patients with knee OA, resulted in significant improvement of validated pain, ROM, and WOMAC-based function scores, when baseline levels were compared at 24 weeks. Further studies with randomized controlled trials involving a comparison group are suggested to confirm these findings.
    Therapeutic advances in musculoskeletal disease 03/2015; 7(2). DOI:10.1177/1759720X14566618
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    • "This absence of evidence means that care is likely to be sub-optimal. While some trials of exercise have reported large, durable and clinically important effects [14], others have not [15]. The types of exercise programs, and patient presentations for chronic LBP vary widely so it is unlikely that all programs are equally effective for all patients[6]. "
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    ABSTRACT: Practice guidelines recommend various types of exercise for chronic back pain but there have been few head-to-head comparisons of these interventions. General exercise seems to be an effective option for management of chronic low back pain (LBP) but very little is known about the management of a sub-acute LBP within sub-groups. Recent research has developed clinical tests to identify a subgroup of patients with chronic non-specific LBP who have movement control dysfunction (MD). We are conducting a randomized controlled trial (RCT) to compare the effects of general exercise and specific movement control exercise (SMCE) on disability and function in patients with MD within recurrent sub-acute LBP. The main outcome measure is the Roland Morris Disability Questionnaire. European clinical guideline for management of chronic LBP recommends that more research is required to develop tools to improve the classification and identification of specific clinical sub-groups of chronic LBP patients. Good quality RCTs are then needed to determine the effectiveness of specific interventions aimed at these specific target groups. This RCT aims to test the hypothesis whether patients within a sub-group of MD benefit more through a specific individually tailored movement control exercise program than through general exercises.
    BMC Musculoskeletal Disorders 04/2012; 13(1):55. DOI:10.1186/1471-2474-13-55 · 1.72 Impact Factor
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    • "One study[40] found a statistically significant difference at intermediate follow-up for pain relief for the exercise group compared to the usual care group. Three studies[27] [50] [60] reported on pain and/or disability at long-term follow-up. The pooled WMD for pain was not statistically significant (À4.94 (95%CI–10.45; "
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    ABSTRACT: Exercise therapy is the most widely used type of conservative treatment for low back pain. Systematic reviews have shown that exercise therapy is effective for chronic but not for acute low back pain. During the past 5 years, many additional trials have been published on chronic low back pain. This articles aims to give an overview on the effectiveness of exercise therapy in patients with low back pain. For this overview, existing Cochrane reviews for the individual interventions were screened for studies fulfilling the inclusion criteria, and the search strategy outlined by the Cochrane Back Review Group (CBRG) was followed. Studies were included if they fulfilled the following criteria: (1) randomised controlled trials,(2) adult (> or =18 years) population with chronic (> or =12 weeks) nonspecific low back pain and (3) evaluation of at least one of the main clinically relevant outcome measures (pain, functional status, perceived recovery or return to work). Two reviewers independently selected studies and extracted data on study characteristics, risk of bias and outcomes at short-term, intermediate and long-term follow-up. The GRADE approach (GRADE, Grading of Recommendations Assessment, Development and Evaluation) was used to determine the quality of evidence. In total, 37 randomised controlled trials met the inclusion criteria and were included in this overview. Compared to usual care, exercise therapy improved post-treatment pain intensity and disability, and long-term function. The authors conclude that evidence from randomised controlled trials demonstrated that exercise therapy is effective at reducing pain and function in the treatment of chronic low back pain. There is no evidence that one particular type of exercise therapy is clearly more effective than others. However, effects are small and it remains unclear which subgroups of patients benefit most from a specific type of treatment.
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