A randomized double-blind trial of dextrose-glycerine-phenol injections for chronic, low back pain. A new approach to the treatment of chronic low back pain. Back pain and sciatica: controlled trials of manipulation, traction, sclerosant and epidural injections. A randomized, double-blind, placebo-controlled trial of sclerosing injections in patients with chronic low back pain. Prolotherapy injections, saline injections, and exercises for chronic low-back pain: a randomized trial.
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. 81 patients with chronic low back pain (average duration 10 years) were randomised to two treatment groups. 40 received an empirically devised regimen of forceful spinal manipulation and injections of a dextrose-glycerine-phenol ("proliferant") solution into soft-tissue structures, as part of a programme to decrease pain and disability. The other 41 patients received parallel treatment in which the main differences were less extensive initial local anaesthesia and manipulation, and substitution of saline for proliferant. Neither patients nor assessors knew which treatment had been given. When assessed by disability scores the experimental group had greater improvement than the control group at one (p less than 0.001), three (p less than 0.004), and six (p less than 0.001) months from the end of treatment; at six months an improvement of more than 50% was recorded in 35 of the experimental group versus 16 of the control group and the numbers free from disability were 15 and 4, respectively (p less than 0.003). Visual analogue pain scores and pain diagrams likewise showed significant advantages for the experimental regimen. 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 determine the clinical efficacy of sclerosing injections in patients with chronic low back pain.
                Randomized, double-blind, placebo-controlled trial of three, once weekly injections of dextrose-glycerine-phenol with lignocaine vs saline plus lignocaine in patients with mechanical back pain of more than 6 months' duration. All patient assessments were performed blind by an experienced physiotherapist. The injections to the ligaments of the L4-5 and L5-S1 lumbar motion segments were given by an orthopaedic physician experienced in the technique, blinded to the nature of the injection solution according to a standard protocol. Demographic and clinical data, the short-form McGill Pain Questionnaire, the modified Somatic Pain Questionnaire, the Zung Depression Inventory, Oswestry Disability Scale and the modified Schober method of measuring spinal flexion were undertaken at 0, 1, 3 and 6 months.
                Seventy-four patients [mean (S.D.) age 45(11) yr, female:male ratio 1:1, median pain duration >10 yr] were recruited and there were no drop-outs over the study period. There were no statistically significant differences in patient characteristics between the placebo and treatment groups at baseline or for any measure at follow-up.
                Three, weekly sclerosant injections alone may not be effective treatment in many patients with undifferentiated chronic back pain. Patient selection and combination with other treatment modalities may be factors in determining treatment success. 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.
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.