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. Surgery with disc prosthesis versus rehabilitation in patients with low back pain and degenerative disc: two year follow-up of randomised study. A randomized trial of combined manipulation, stabilizing exercises, and physician consultation compared to physician consultation alone for chronic low back pain. Active exercise, education, and cognitive behavioral therapy for persistent disabling low back pain: a randomized controlled trial. A randomized, controlled trial of manual therapy and specific adjuvant exercise for chronic low back pain.
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. To compare the efficacy of surgery with disc prosthesis versus non-surgical treatment for patients with chronic low back pain.
                A prospective randomised multicentre study.
                Five university hospitals in Norway.
                173 patients with a history of low back pain for at least one year, Oswestry disability index of at least 30 points, and degenerative changes in one or two lower lumbar spine levels (86 patients randomised to surgery). Patients were treated from April 2004 to September 2007.
                Surgery with disc prosthesis or outpatient multidisciplinary rehabilitation for 12-15 days.
                The primary outcome measure was the score on the Oswestry disability index after two years. Secondary outcome measures were low back pain, satisfaction with life (SF-36 and EuroQol EQ-5D), Hopkins symptom check list (HSCL-25), fear avoidance beliefs (FABQ), self efficacy beliefs for pain, work status, and patients' satisfaction and drug use. A blinded independent observer evaluated scores on the back performance scale and Prolo scale at two year follow-up.
                The study was powered to detect a difference of 10 points on the Oswestry disability index between the groups at two years. At two years there was a mean difference of -8.4 points (95% confidence interval -13.2 to -3.6) in favour of surgery. In the analysis of prespecified secondary outcomes, there were significant differences in favour of surgery for low back pain (mean difference -12.2, -21.3 to -3.1), patients' satisfaction (63% (n = 46) v 39% (n = 26)), SF-36 physical component score (mean difference 5.8, 2.5 to 9.1), self efficacy for pain (mean difference 1.0, 0.2 to 1.9), and the Prolo scale (mean difference 0.9, 0.1 to 1.6). There were no significant differences in return to work, SF-36 mental component score, EQ-5D, fear avoidance beliefs, Hopkins symptom check list, drug use, and the back performance scale. One serious complication of leg amputation occurred during surgical revision of a polyethylene dislodgement. The drop-out rate was 20% (34) and the crossover rate was 6% (5).
                Surgical intervention with disc prosthesis for chronic low back pain resulted in a significantly greater improvement in the Oswestry score compared with rehabilitation, but this improvement did not clearly exceed the prespecified minimally important clinical difference between groups of 10 points, and the data are consistent with a wide range of differences between the groups, including values well below 10 points. The potential risks of surgery and the substantial amount of improvement experienced by a sizeable proportion of the rehabilitation group also have to be incorporated into overall decision making. Trial registration NCT 00394732. A prospective randomized controlled trial.
                To examine the effectiveness of combined manipulative treatment, stabilizing exercises, and physician consultation compared with physician consultation alone for chronic low back pain.
                Strong evidence exists that manual therapy provides more effective short-term pain relief than does placebo treatment in the management of chronic low back pain. The evidence for long-term effect is lacking.
                Two hundred four chronic low back pain patients, whose Oswestry disability index was at least 16%, were randomly assigned to either a manipulative-treatment group or a consultation group. All were clinically examined, informed about their back pain, provided with an educational booklet, and were given specific instructions based on the clinical evaluation. The treatment included four sessions of manipulation and stabilizing exercises aiming to correct the lumbopelvic rhythm. Questionnaires inquired about pain intensity, self-rated disability, mental depression, health-related quality of life, health care costs, and production costs.
                At the baseline, the groups were comparable, except for the percentage of employees (P = 0.01). At the 5- and 12-month follow-ups, the manipulative-treatment group showed more significant reductions in pain intensity (P < 0.001) and in self-rated disability (P = 0.002) than the consultation group. However, we detected no significant difference between the groups in health-related quality of life or in costs.
                The manipulative treatment with stabilizing exercises was more effective in reducing pain intensity and disability than the physician consultation alone. The present study showed that short, specific treatment programs with proper patient information may alter the course of chronic low back pain. A randomized controlled trial.
                To determine 1) whether, among patients with persistent disabling low back pain (LBP), a group program of exercise and education using a cognitive behavioral therapy (CBT) approach, reduces pain and disability over a subsequent 12-month period; 2) the cost-effectiveness of the intervention; and 3) whether a priori preference for type of treatment influences outcome.
                There is evidence that both exercise and CBT delivered in specialist settings is effective in improving LBP. There is a lack of evidence on whether such interventions, delivered by trained individuals in primary care, result in improved outcomes.
                The study was conducted in nine family medical practices in East Cheshire, UK. Patients 18 to 65 years of age, consulting with LBP, were recruited; those still reporting LBP 3 months after the initial consultation were randomized between the two trial arms. The intervention arm received a program of eight 2-hour group exercise session over 6 weeks comprising active exercise and education delivered by physiotherapists using a CBT approach. Both arms received an educational booklet and audio-cassette. The primary outcome measures were pain (0-100 Visual Analogue Scale) and disability (Roland and Morris Disability Scale; score 0-24).
                A total of 196 subjects (84%) completed follow-up 12 months after the completion of the intervention program. The intervention showed only a small and nonsignificant effect at reducing pain (-3.6 mm; 95% confidence interval, -8.5, 1.2 mm) and disability (-0.6 score; 95% confidence interval, -1.6, 0.4). The cost of the intervention was low with an incremental cost-effectiveness ratio of pound5000 (U.S. $8650) per quality adjusted life year. In addition, patients allocated to the intervention that had expressed a preference for it had clinically important reductions in pain and disability.
                This intervention program produces only modest effects in reducing LBP and disability over a 1-year period. The observation that patient preference for treatment influences outcome warrants further investigation. This article examines the effectiveness of manual therapy with specific adjuvant exercise for treating chronic low back pain and disability.
                A single blind, randomized, controlled trial was employed. Patients were prescribed an exercise program that was tailored to treat their musculoskeletal dysfunctions or given a nonspecific program of general stretching and aerobic conditioning. In addition, patients received manual therapy or sham manual therapy. Participants were seen for 6 weekly sessions and were asked to perform their exercise program twice daily.
                Seventy-two out of 100 patients completed the study. Multivariate tests conducted for measures of pain and disability revealed a significant group by time interaction (P = 0.04 and P = 0.05, respectively), indicating differential change in these measures pretreatment to posttreatment as a function of the treatment received. When controlling for pretreatment scores, patients receiving manual therapy with specific adjuvant exercise reported significant reductions in pain. No change in perceived disability was observed, with the exception that patients receiving sham manual therapy with specific adjuvant exercise reported significantly greater disability at posttreatment.
                Manual therapy with specific adjuvant exercise appears to be beneficial in treating chronic low back pain. Despite changes in pain, perceived function did not improve. It is possible that impacting chronic low back pain alone does not address psychosocial or other factors that may contribute to disability. Further studies are needed to examine the long-term effects of these interventions and to address what adjuncts are beneficial in improving function in this population.
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.