Prolotherapy injections, saline injections, and exercises for chronic low-back pain: A randomized trial
ABSTRACT 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.
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.
SourceAvailable from: Fariba Eslamian[Show abstract] [Hide abstract]
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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ABSTRACT: Evidence suggests that the course of low back pain (LBP) symptoms in randomised clinical trials (RCTs) follows a pattern of large improvement regardless of the type of treatment. A similar pattern was independently observed in observational studies. However, there is an assumption that the clinical course of symptoms is particularly influenced in RCTs by mere participation in the trials. To test this assumption, the aim of our study was to compare the course of LBP in RCTs and observational studies. Source of studies CENTRAL database for RCTs and MEDLINE, CINAHL, EMBASE and hand search of systematic reviews for cohort studies. Studies include individuals aged 18 or over, and concern non-specific LBP. Trials had to concern primary care treatments. Data were extracted on pain intensity. Meta-regression analysis was used to compare the pooled within-group change in pain in RCTs with that in cohort studies calculated as the standardised mean change (SMC). 70 RCTs and 19 cohort studies were included, out of 1134 and 653 identified respectively. LBP symptoms followed a similar course in RCTs and cohort studies: a rapid improvement in the first 6 weeks followed by a smaller further improvement until 52 weeks. There was no statistically significant difference in pooled SMC between RCTs and cohort studies at any time point:- 6 weeks: RCTs: SMC 1.0 (95% CI 0.9 to 1.0) and cohorts 1.2 (0.7to 1.7); 13 weeks: RCTs 1.2 (1.1 to 1.3) and cohorts 1.0 (0.8 to 1.3); 27 weeks: RCTs 1.1 (1.0 to 1.2) and cohorts 1.2 (0.8 to 1.7); 52 weeks: RCTs 0.9 (0.8 to 1.0) and cohorts 1.1 (0.8 to 1.6). The clinical course of LBP symptoms followed a pattern that was similar in RCTs and cohort observational studies. In addition to a shared 'natural history', enrolment of LBP patients in clinical studies is likely to provoke responses that reflect the nonspecific effects of seeking and receiving care, independent of the study design.BMC Musculoskeletal Disorders 03/2014; 15(1):68. DOI:10.1186/1471-2474-15-68 · 1.90 Impact Factor
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ABSTRACT: To compare the advantages of prolotherapy in the treatment of first carpometacarpal osteoarthritis (OA) with those of corticosteroid local injection in the short and long term. We performed a randomized controlled trial from March 2010 to March 2011 in an outpatient clinic at a university hospital. Sixty participants (60 hands) with OA of the first carpometacarpal joint were assigned equally to two groups. For the corticosteroid group, after 2 monthly saline placebo injections, a single dose of 40 mg methylprednisolone acetate (0.5 ml) mixed with 0.5 ml of 2 % lidocaine was injected. For the dextrose (DX) group, 0.5 ml of 20 % DX was mixed with 0.5 ml of 2 % lidocaine and the injection was repeated monthly for 3 months. Pain intensity, hand function and the strength of lateral pinch grip were measured at the baseline and at 1, 2, and 6 months after the treatment. Mean age (STD) was 63.6 (9.7) years, and mean (STD) visual analog scale (VAS) was 6 (2). The two groups were comparable at 2 months, but significantly different at 1 month, with better results for corticosteroid, and at 6 months with apparently more favorable outcome for DX [mean difference (95 % CI) in VAS = 1.1 (0.2, 2.0), p = 0.02]. After 6 months of treatment, both DX and corticosteroid injection increased functional level, but DX seemed to be more effective [mean difference (95 % CI) in total function score = 1.0 (0.2, 1.8), p = 0.01]. For the long term, DX seems to be more advantageous, while the two treatments were comparable in the short term. Because of the satisfactory pain relief and restoring of function, we would prefer DX prolotherapy for the treatment of patients with OA. Therapeutic studies--investigating the results of treatment; level I.Journal of Orthopaedic Science 08/2014; 19(5). DOI:10.1007/s00776-014-0587-2 · 1.01 Impact Factor