OBJECTIVE: Determine the relative effectiveness and safety profiles of percutaneous and minimally invasive interventions for chronic low back pain.
METHODS: A systematic search was performed for randomized controlled trials (RCTs) published in the past 20 years reporting on radiofrequency (RF) ablation of the basivertebral, disc annulus and facet nerve structures, steroid injection of the disc, facet joint and medial branch, biologic therapies, and multifidus muscle stimulation. Outcomes evaluated included Visual Analog Scale (VAS) pain scores, Oswestry Disability Index (ODI) scores, quality of life (SF-36 and EQ-5D) scores and serious adverse event (SAE) rates. Basivertebral nerve (BVN) ablation was chosen as the subject of comparison to all other therapies using a random-effects meta-analysis.
RESULTS: Twenty-seven studies were included. BVN ablation was found to provide significant improvements in VAS and ODI scores for 6-, 12- and 24-months follow-up (P≤0.05). Biologic therapy and multifidus muscle stimulation were the only two treatments with both VAS and ODI outcomes not significantly different from BVN ablation at 6-, 12- and 24-months follow-up. All outcomes found to be statistically significant represented inferior results to those of BVN ablation. Insufficient data precluded meaningful comparisons of SF-36 and EQ-5D scores. The SAE rates for all therapies and all reported time points were not significantly different from BVN ablation except for biologic therapy and multifidus muscle stimulation at 6-months follow- up.
CONCLUSIONS: BVN ablation, biologic therapy and multifidus stimulation all provide significant, durable improvements in both pain and disability compared to other interventions, which provided only short-term pain relief. Studies on BVN ablation reported no SAEs, a significantly better result than for studies of biologic therapy and multifidus stimulation.
OBJECTIVES: To analyse the impact of placebo effects on outcome in trials of selected minimally invasive procedures and to assess reported adverse events in both trial arms.
DESIGN: A systematic review and meta-analysis.
DATA SOURCES AND STUDY SELECTION: We searched MEDLINE and Cochrane library to identify systematic reviews of musculoskeletal, neurological and cardiac conditions published between January 2009 and January 2014 comparing selected minimally invasive with placebo (sham) procedures. We searched MEDLINE for additional randomised controlled trials published between January 2000 and January 2014.
DATA SYNTHESIS: Effect sizes (ES) in the active and placebo arms in the trials' primary and pooled secondary end points were calculated. Linear regression was used to analyse the association between end points in the active and sham groups. Reported adverse events in both trial arms were registered.
RESULTS: We included 21 trials involving 2519 adult participants. For primary end points, there was a large clinical effect (ES≥0.8) after active treatment in 12 trials and after sham procedures in 11 trials. For secondary end points, 7 and 5 trials showed a large clinical effect. Three trials showed a moderate difference in ES between active treatment and sham on primary end points (ES ≥0.5) but no trials reported a large difference. No trials showed large or moderate differences in ES on pooled secondary end points. Regression analysis of end points in active treatment and sham arms estimated an R(2) of 0.78 for primary and 0.84 for secondary end points. Adverse events after sham were in most cases minor and of short duration.
CONCLUSIONS: The generally small differences in ES between active treatment and sham suggest that non-specific mechanisms, including placebo, are major predictors of the observed effects. Adverse events related to sham procedures were mainly minor and short-lived. Ethical arguments frequently raised against sham-controlled trials were generally not substantiated.
Journal»European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
OBJECTIVE: The objective of this study was to determine the representative outcomes of the intradiscal electrothermal therapy (IDET) procedure in terms of pain relief, reduction of disability, and risk of complications. DESIGN: Meta-analysis, using a random-effects model. A Medline literature search was conducted using search terms associated with the IDET procedure including IDET, intradiscal electrothermal therapy, intervertebral disk, and annuloplasty. OUTCOME MEASURES: The outcomes analyzed were the visual analog scale (VAS) assessment of pain, the bodily pain, and physical functioning subscales of the SF-36 health survey, and the Oswestry disability index. RESULTS: From 1998 to March 2005, 62 peer-reviewed articles were identified regarding the IDET procedure. Forty-five articles were excluded, leaving a total of 17 unique published reports included in this review. The overall mean improvement in pain intensity was 2.9 points as measured by the VAS. The overall mean improvement in physical function was 21.1 points as measured by the SF-36. The overall mean improvement in bodily pain was 18.0 points as measured by the SF-36. The overall mean improvement in disability was 7.0 points as measured by the Oswestry disability index. The overall incidence of complications was 0.8%. CONCLUSION: Although variation exists in the reported outcomes among the various studies of the IDET procedure, the pooled results of the published studies provide compelling evidence of the relative efficacy and safety of the IDET procedure.
BACKGROUND: Surgical investigations and interventions account for large health care utilisation and costs, but the scientific evidence for most procedures is still limited.
OBJECTIVES: Degenerative conditions affecting the lumbar spine are variously described as lumbar spondylosis or degenerative disc disease (which we regarded as one entity) and may be associated with back pain and associated leg symptoms, instability, spinal stenosis and/or degenerative spondylolisthesis. The objective of this review was to assess current scientific evidence on the effectiveness of surgical interventions for degenerative lumbar spondylosis.
SEARCH METHODS: We searched CENTRAL, MEDLINE, PubMed, Spine and ISSLS abstracts, with citation tracking from the retrieved articles. We also corresponded with experts. All data found up to 31 March 2005 are included.
SELECTION CRITERIA: Randomised (RCTs) or quasi-randomised trials of surgical treatment of lumbar spondylosis.
DATA COLLECTION AND ANALYSIS: Two authors assessed trial quality and extracted data from published papers. Additional information was sought from the authors if necessary.
MAIN RESULTS: Thirty-one published RCTs of all forms of surgical treatment for degenerative lumbar spondylosis were identified. The trials varied in quality: only the more recent trials used appropriate methods of randomization, blinding and independent assessment of outcome. Most of the earlier published results were of technical surgical outcomes with some crude ratings of clinical outcome. More of the recent trials also reported patient-centered outcomes of pain or disability, but there is still very little information on occupational outcomes. There was a particular lack of long term outcomes beyond two to three years. Seven heterogeneous trials on spondylolisthesis, spinal stenosis and nerve compression permitted limited conclusions. Two new trials on the effectiveness of fusion showed conflicting results. One showed that fusion gave better clinical outcomes than conventional physiotherapy, while the other showed that fusion was no better than a modern exercise and rehabilitation programme. Eight trials showed that instrumented fusion produced a higher fusion rate (though that needs to be qualified by the difficulty of assessing fusion in the presence of metal-work), but any improvement in clinical outcomes is probably marginal, while there is other evidence that it may be associated with higher complication rates. Three trials with conflicting results did not permit any conclusions about the relative effectiveness of anterior, posterior or circumferential fusion. Preliminary results of two small trials of intra-discal electrotherapy showed conflicting results. Preliminary data from three trials of disc arthroplasty did not permit any firm conclusions.
AUTHORS' CONCLUSIONS: Limited evidence is now available to support some aspects of surgical practice. Surgeons should be encouraged to perform further RCTs in this field.
Determine the relative effectiveness and safety profiles of percutaneous and minimally invasive interventions for chronic low back pain.
METHODS:
A systematic search was performed for randomized controlled trials (RCTs) published in the past 20 years reporting on radiofrequency (RF) ablation of the basivertebral, disc annulus and facet nerve structures, steroid injection of the disc, facet joint and medial branch, biologic therapies, and multifidus muscle stimulation. Outcomes evaluated included Visual Analog Scale (VAS) pain scores, Oswestry Disability Index (ODI) scores, quality of life (SF-36 and EQ-5D) scores and serious adverse event (SAE) rates. Basivertebral nerve (BVN) ablation was chosen as the subject of comparison to all other therapies using a random-effects meta-analysis.
RESULTS:
Twenty-seven studies were included. BVN ablation was found to provide significant improvements in VAS and ODI scores for 6-, 12- and 24-months follow-up (P≤0.05). Biologic therapy and multifidus muscle stimulation were the only two treatments with both VAS and ODI outcomes not significantly different from BVN ablation at 6-, 12- and 24-months follow-up. All outcomes found to be statistically significant represented inferior results to those of BVN ablation. Insufficient data precluded meaningful comparisons of SF-36 and EQ-5D scores. The SAE rates for all therapies and all reported time points were not significantly different from BVN ablation except for biologic therapy and multifidus muscle stimulation at 6-months follow- up.
CONCLUSIONS:
BVN ablation, biologic therapy and multifidus stimulation all provide significant, durable improvements in both pain and disability compared to other interventions, which provided only short-term pain relief. Studies on BVN ablation reported no SAEs, a significantly better result than for studies of biologic therapy and multifidus stimulation.
