LOW BACK/SACROILIAC PAIN
RCT # 1: Yelland MJ, Glasziou PP, Bogduk N, et al. Prolotherapy injections, saline injections, and exercises for chronic low-back pain: a randomized trial. Spine 2004;29:9-16.
ABSTRACT
OBJECTIVES: To assess the efficacy of a prolotherapy injection and exercise protocol in the treatment of chronic nonspecific low back pain.
DESIGN: Randomized controlled trial with two-by-two factorial design, triple-blinded for injection status, and single-blinded for exercise status.
SETTING: General practice.
PARTICIPANTS: 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.
MAIN OUTCOME MEASURES: Pain intensity (VAS) and disability scores (Roland-Morris) at 2.5, 4, 6, 12, and 24 months.
RESULTS:
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.
CONCLUSIONS: 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.
RISK OF BIAS TABLE USING COCHRANE CRITERIA (Modified from Reeves KD, Sit RWS, Rabago D. Dextrose Prolotherapy: A narrative review of basic science and clinical research, and best treatment recommendations. Phys Med Rehabil Clin N Am; 2016; 27(4); 783-823;. DOI 10.1016/j.pmr.2016.06.001)
ABSTRACT
OBJECTIVES: To assess the efficacy of a prolotherapy injection and exercise protocol in the treatment of chronic nonspecific low back pain.
DESIGN: Randomized controlled trial with two-by-two factorial design, triple-blinded for injection status, and single-blinded for exercise status.
SETTING: General practice.
PARTICIPANTS: 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.
MAIN OUTCOME MEASURES: Pain intensity (VAS) and disability scores (Roland-Morris) at 2.5, 4, 6, 12, and 24 months.
RESULTS:
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.
CONCLUSIONS: 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.
RISK OF BIAS TABLE USING COCHRANE CRITERIA (Modified from Reeves KD, Sit RWS, Rabago D. Dextrose Prolotherapy: A narrative review of basic science and clinical research, and best treatment recommendations. Phys Med Rehabil Clin N Am; 2016; 27(4); 783-823;. DOI 10.1016/j.pmr.2016.06.001)
Sequence Generation |
Allocation Concealment |
Blinding of Participants & Researchers |
Blinding of Outcome Assessment |
Incomplete Outcome Data Addressed |
Selective Data Reporting |
Low |
Low |
Low |
Low |
Low |
Unclear |
Computer-generated random number system |
Off-site randomi-zation) |
Off-site solution preparation |
Assessors masked |
4% loss of data to 1 year. (ITT used) |
No protocol was provided) |
SUMMARY Yelland et al low back pain RCT
Yelland et al. compared DPT and normal saline in addition to either exercise or usual care in a factorial design. Participants with chronic back pain and failure of conservative treatment received 6 treatments at 2 week intervals and then as needed at 4, 6, 12 and 24 months, consistent with a published protocol.56 Participants were masked to solution type for the 24 month period of the study. Effects were assessed using the Roland-Morris (R-M) disability score and a 0-100 VAS for pain. Data was collected at 12 and 24 months.
Participants had statistically similar baseline characteristics. At 12-months, no statistical difference was found between exercise and normal activity. DPT and NS groups also did not differ in terms of the change in R-M disability score (5.5±0.9;36% vs 4.5±0.8;26%: p=.60) or pain intensity measured by a VAS (18.6±3.2 ponts;36% vs 18.4±4.0 points;33%; p= .93). However, 12 month improvements exceeded the minimally important change (MIC) for the R-M disability score (30% or 5.0)57 in the dextrose group, and the 0-100 VAS pain score (20% or 15 points) in both groups. Greater than 50% pain reduction was observed in 46% and 36% of dextrose and saline groups respectively at 12 months. Improvements were durable to 24 months.
Yelland et al. compared DPT and normal saline in addition to either exercise or usual care in a factorial design. Participants with chronic back pain and failure of conservative treatment received 6 treatments at 2 week intervals and then as needed at 4, 6, 12 and 24 months, consistent with a published protocol.56 Participants were masked to solution type for the 24 month period of the study. Effects were assessed using the Roland-Morris (R-M) disability score and a 0-100 VAS for pain. Data was collected at 12 and 24 months.
Participants had statistically similar baseline characteristics. At 12-months, no statistical difference was found between exercise and normal activity. DPT and NS groups also did not differ in terms of the change in R-M disability score (5.5±0.9;36% vs 4.5±0.8;26%: p=.60) or pain intensity measured by a VAS (18.6±3.2 ponts;36% vs 18.4±4.0 points;33%; p= .93). However, 12 month improvements exceeded the minimally important change (MIC) for the R-M disability score (30% or 5.0)57 in the dextrose group, and the 0-100 VAS pain score (20% or 15 points) in both groups. Greater than 50% pain reduction was observed in 46% and 36% of dextrose and saline groups respectively at 12 months. Improvements were durable to 24 months.
RCT # 2: Kim WM, Lee HG, Jeong CW, et al. A randomized controlled trial of intra-articular prolotherapy versus steroid injection for sacroiliac joint pain. J Altern Complement Med 2010;16:1285-90.
ABSTRACT
OBJECTIVES: To assess the efficacy of a prolotherapy injection and exercise protocol in the treatment of chronic nonspecific low back pain.
DESIGN: Randomized controlled trial with two-by-two factorial design, triple-blinded for injection status, and single-blinded for exercise status.
SETTING: General practice.
PARTICIPANTS: 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.
MAIN OUTCOME MEASURES: Pain intensity (VAS) and disability scores (Roland-Morris) at 2.5, 4, 6, 12, and 24 months.
RESULTS:
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.
CONCLUSIONS: 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.
RISK OF BIAS TABLE USING COCHRANE CRITERIA (Modified from Reeves KD, Sit RWS, Rabago D. Dextrose Prolotherapy: A narrative review of basic science and clinical research, and best treatment recommendations. Phys Med Rehabil Clin N Am; 2016; 27(4); 783-823;. DOI 10.1016/j.pmr.2016.06.001)
ABSTRACT
OBJECTIVES: To assess the efficacy of a prolotherapy injection and exercise protocol in the treatment of chronic nonspecific low back pain.
DESIGN: Randomized controlled trial with two-by-two factorial design, triple-blinded for injection status, and single-blinded for exercise status.
SETTING: General practice.
PARTICIPANTS: 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.
MAIN OUTCOME MEASURES: Pain intensity (VAS) and disability scores (Roland-Morris) at 2.5, 4, 6, 12, and 24 months.
RESULTS:
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.
CONCLUSIONS: 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.
RISK OF BIAS TABLE USING COCHRANE CRITERIA (Modified from Reeves KD, Sit RWS, Rabago D. Dextrose Prolotherapy: A narrative review of basic science and clinical research, and best treatment recommendations. Phys Med Rehabil Clin N Am; 2016; 27(4); 783-823;. DOI 10.1016/j.pmr.2016.06.001)
Sequence Generation |
Allocation Concealment |
Blinding of Participants & Researchers |
Blinding of Outcome Assessment |
Incomplete Outcome Data Addressed |
Selective Data Reporting |
Low |
Unclear |
Low |
Low |
Low |
Unclear |
Computer-generated random number system |
Relevant information was not reported) |
Researcher and patient masked. Injector not masked but no other interaction with participant. |
Outcome assessor was blinded |
Only 2/48 lost to follow up |
No protocol was provided |
SUMMARY Kim et al. low back pain RCT
WM Kim et al. compared DPT to steroid injection in a 2 arm blinded trial (Figure 22, table 3) Participants with pain more than 3 months localized below the posterior superior iliac spine with positive Patrick and Gaenslen’s test, and pain reduction more than 50% with fluoroscopic injection of 0.25% levobupivacaine were recruited in this study. Injections were performed at 0, 2 and 4 weeks or until pain improvement more than 90% was reached. The primary measure was a 0-10 NRS pain scale and data was collected pre-treatment and at 2 weeks, and 6, 10 and 15 months following the last injection. Participants had significantly similar baseline characteristics. The dextrose group received more injections than the steroid group (2.7±1.1 vs 1.5±0.8) to achieve an initial 90% improvement. By 6 months significantly more participants in the dextrose group than steroid group remained more than 50% improvement, and at 9 months the difference plateaued (58.7±20.8 percent versus 10.2±16.9 percent; p < .01) and was sustained to follow-up at 15 months.
WM Kim et al. compared DPT to steroid injection in a 2 arm blinded trial (Figure 22, table 3) Participants with pain more than 3 months localized below the posterior superior iliac spine with positive Patrick and Gaenslen’s test, and pain reduction more than 50% with fluoroscopic injection of 0.25% levobupivacaine were recruited in this study. Injections were performed at 0, 2 and 4 weeks or until pain improvement more than 90% was reached. The primary measure was a 0-10 NRS pain scale and data was collected pre-treatment and at 2 weeks, and 6, 10 and 15 months following the last injection. Participants had significantly similar baseline characteristics. The dextrose group received more injections than the steroid group (2.7±1.1 vs 1.5±0.8) to achieve an initial 90% improvement. By 6 months significantly more participants in the dextrose group than steroid group remained more than 50% improvement, and at 9 months the difference plateaued (58.7±20.8 percent versus 10.2±16.9 percent; p < .01) and was sustained to follow-up at 15 months.
A literature review in December of 2020 revealed no additional RCTs in this area
Metaanalysis: Dagenais S, Mayer J, Haldeman S, et al. Evidence-informed management of chronic low back pain with prolotherapy. Spine J 2008;8:203-12
ABSTRACT
The management of chronic low back pain (CLBP) has proven to be very challenging in North America, as evidenced by its mounting socioeconomic burden. Choosing among available nonsurgical therapies can be overwhelming for many stakeholders, including patients, health providers, policy makers, and third-party payers. Although all parties share a common goal and wish to use limited health-care resources to support interventions most likely to result in clinically meaningful improvements, there is often uncertainty about the most appropriate intervention for a particular patient. To help understand and evaluate the various commonly used nonsurgical approaches to CLBP, the North American Spine Society has sponsored this special focus issue of The Spine Journal, titled Evidence-informed Management of Chronic Low Back Pain Without Surgery. Articles in this special focus issue were contributed by leading spine practitioners and researchers, who were invited to summarize the best available evidence for a particular intervention and encouraged to make this information accessible to non experts. Each of the articles contains five sections (description, theory, evidence of efficacy, harms, and summary) with common subheadings to facilitate comparison across the 24 different interventions profiled in this special focus issue, blending narrative and systematic review methodology as deemed appropriate by the authors. It is hoped that articles in this special focus issue will be informative and aid in decision making for the many stakeholders evaluating nonsurgical interventions for CLBP
SUMMARY of Dagenais et al. metaanalysis of prolotherapy for low back pain
Comment: A Cochrane review by Dagenais et al. in 2007 evaluated the role of prolotherapy in low back pain. The review included five eligible studies, and concluded prolotherapy alone is not effective for chronic LBP; however, four out of the 5 studies used a mixture of prolotherapy solutions containing dextrose, glycerine and phenol, which may not allow full evaluation of DPT alone in LBP. More high quality RCTs utilizing DPT alone in low back and SIJ are needed in order to confirm or refute its efficacy in lumbosacral pain. Injection results in sacroiliac pain, however, favor DPT use over steroid for intraarticular injection into the symptomatic sacroiliac joint.
ABSTRACT
The management of chronic low back pain (CLBP) has proven to be very challenging in North America, as evidenced by its mounting socioeconomic burden. Choosing among available nonsurgical therapies can be overwhelming for many stakeholders, including patients, health providers, policy makers, and third-party payers. Although all parties share a common goal and wish to use limited health-care resources to support interventions most likely to result in clinically meaningful improvements, there is often uncertainty about the most appropriate intervention for a particular patient. To help understand and evaluate the various commonly used nonsurgical approaches to CLBP, the North American Spine Society has sponsored this special focus issue of The Spine Journal, titled Evidence-informed Management of Chronic Low Back Pain Without Surgery. Articles in this special focus issue were contributed by leading spine practitioners and researchers, who were invited to summarize the best available evidence for a particular intervention and encouraged to make this information accessible to non experts. Each of the articles contains five sections (description, theory, evidence of efficacy, harms, and summary) with common subheadings to facilitate comparison across the 24 different interventions profiled in this special focus issue, blending narrative and systematic review methodology as deemed appropriate by the authors. It is hoped that articles in this special focus issue will be informative and aid in decision making for the many stakeholders evaluating nonsurgical interventions for CLBP
SUMMARY of Dagenais et al. metaanalysis of prolotherapy for low back pain
Comment: A Cochrane review by Dagenais et al. in 2007 evaluated the role of prolotherapy in low back pain. The review included five eligible studies, and concluded prolotherapy alone is not effective for chronic LBP; however, four out of the 5 studies used a mixture of prolotherapy solutions containing dextrose, glycerine and phenol, which may not allow full evaluation of DPT alone in LBP. More high quality RCTs utilizing DPT alone in low back and SIJ are needed in order to confirm or refute its efficacy in lumbosacral pain. Injection results in sacroiliac pain, however, favor DPT use over steroid for intraarticular injection into the symptomatic sacroiliac joint.