Prolotherapy injections, saline injections, and exercises for chronic low-back pain: a randomized trial. A prospective, randomized, double-blind evaluation of trigger-point injection therapy for low-back pain. A randomized double-blind trial of dextrose-glycerine-phenol injections for chronic, low back pain. A randomized controlled trial investigating the efficiency of musculoskeletal physiotherapy on chronic low back disorder. Back pain and sciatica: controlled trials of manipulation, traction, sclerosant and epidural injections.
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. The efficacy of trigger-point injection therapy in treatment of low-back strain was evaluated in a prospective, randomized, double-blind study. The patient population consisted of 63 individuals with low-back strain. Patients with this diagnosis had nonradiating low-back pain, normal neurologic examination, absence of tension signs, and lumbosacral roentgenograms interpreted as being within normal limits. They were treated conservatively for 4 weeks before entering the study. Injection therapy was of four different types: lidocaine, lidocaine combined with a steroid, acupuncture, and vapocoolant spray with acupressure. Results indicated that therapy without injected medication (63% improvement rate) was at least as effective as therapy with drug injection (42% improvement rate), at a P value of 0.09. Trigger-point therapy seems to be a useful adjunct in treatment of low-back strain. The injected substance apparently is not the critical factor, since direct mechanical stimulus to the trigger-point seems to give symptomatic relief equal to that of treatment with various types of injected medication. This randomized clinical trial evaluated the efficacy of injections of a dextrose-glycerine-phenol connective tissue proliferant into the posterior ligaments, fascia, and joint capsules to treat chronic low back pain. Seventy-nine patients with chronic low back pain that had failed to respond to previous conservative care were randomly assigned to receive a double-blind series of six injections at weekly intervals of either Xylocaine/saline solution or Xylocaine/proliferant into the posterior sacroiliac and interspinous ligaments, fascia, and joint capsules of the low back from L4 to the sacrum. Patients were observed with a visual analog, disability, and pain grid scores, and with objective computerized triaxial tests of lumbar function for 6 months following conclusion of injections. Pretreatment imaging tests with either magnetic resonance imaging (MRI) or computed tomography (CT) scans were performed in all patients. Thirty of the 39 patients randomly assigned to the proliferant group achieved a 50% or greater diminution in pain or disability scores at 6 months compared to 21 of 40 in the group receiving lidocaine (p = 0.042). Subjective parameters measured at 6 months posttreatment improved (p < 0.001) overall in both the treatment and control group compared to baseline. Improvements in visual analog (p = 0.056), disability (p = 0.068), and pain grid scores (p = 0.025) were greater in the proliferant group. Objective testing of range of motion, isometric strength, and velocity of movement showed significant improvements in both groups following treatment but did not favor either group. The MRI and CT scans showed significant abnormalities in both groups, but these did not correlate with subjective complaints and were not predictive of response to treatment. Randomized, single blind, controlled trial.
                To determine the efficacy of 2 components of musculoskeletal physiotherapy on chronic low back disorder.
                Musculoskeletal physiotherapy encompasses many treatment methods, however, manual therapy and exercises to rehabilitate spinal stabilization are the most frequently used. Despite their popularity, scant evidence supports their use on subjects with chronic low back disorder.
                A total of 346 subjects were randomized to manual therapy, a 10-week spinal stabilization rehabilitation program, or a minimal intervention control group. Data were collected at baseline, and 3, 6, 12, and 24 months after intervention. Outcome measures recorded intensity of low back pain, disability, handicap, medication, and quality of life. There were 4 main variables combined in a primary component analysis to form a single outcome measure (i.e., a measure of dysfunction).
                The results indicated statistically significant improvements in favor of the spinal stabilization group at the 6-month stage in pain (65.9% reduction in symptoms) and dysfunction (combined mean reduction of 134, standard error 23.84), and at the 1-year stage in medication (34.3% reduction in medication), dysfunction (combined mean reduction of 134, standard error 18.2), and disability (mean difference in change 15.71 Oswestry Disability Index, 95% confidence interval 19.3-10.01).
                As a component of musculoskeletal physiotherapy, the spinal stabilization program is more effective than manually applied therapy or an education booklet in treating chronic low back disorder over time. Both manual therapy and the spinal stabilization program are significantly effective in pain reduction in comparison to an active control. To our knowledge and up until now, this result has not been shown in patients with chronic low back disorder. Four treatment regimens for patients with specified combinations of low back pain and sciatica were evaluated. The largest group studied had low back pain with limited straight-leg raising (SLR) and in them the beneficial effect of manipulation in hastening pain relief was highly significant. In similar patients without limitation of SLR, the effect was of borderline significance. In all the other groups, treated patients also recovered more quickly than their controls. Traction, for patients with low back pain and sciatica, and epidural injections when a root palsy was present also produced some significant pain relief. The effect of sclerosants for back pain was less clear.
There is conflicting evidence regarding the efficacy of prolotherapy injections for patients with chronic low-back pain. When used alone, prolotherapy is not an effective treatment for chronic low-back pain. When combined with spinal manipulation, exercise, and other co-interventions, prolotherapy may improve chronic low-back pain and disability. Conclusions are confounded by clinical heterogeneity amongst studies and by the presence of co-interventions.