AIM: To investigate the diagnostic validity and therapeutic value of lumbar facet joint interventions in managing chronic low back pain.
METHODS: The review process applied systematic evidence-based assessment methodology of controlled trials of diagnostic validity and randomized controlled trials of therapeutic efficacy. Inclusion criteria encompassed all facet joint interventions performed in a controlled fashion. The pain relief of greater than 50% was the outcome measure for diagnostic accuracy assessment of the controlled studies with ability to perform previously painful movements, whereas, for randomized controlled therapeutic efficacy studies, the primary outcome was significant pain relief and the secondary outcome was a positive change in functional status. For the inclusion of the diagnostic controlled studies, all studies must have utilized either placebo controlled facet joint blocks or comparative local anesthetic blocks. In assessing therapeutic interventions, short-term and long-term reliefs were defined as either up to 6 mo or greater than 6 mo of relief. The literature search was extensive utilizing various types of electronic search media including PubMed from 1966 onwards, Cochrane library, National Guideline Clearinghouse, clinicaltrials.gov, along with other sources including previous systematic reviews, non-indexed journals, and abstracts until March 2015. Each manuscript included in the assessment was assessed for methodologic quality or risk of bias assessment utilizing the Quality Appraisal of Reliability Studies checklist for diagnostic interventions, and Cochrane review criteria and the Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment tool for therapeutic interventions. Evidence based on the review of the systematic assessment of controlled studies was graded utilizing a modified schema of qualitative evidence with best evidence synthesis, variable from level I to level V.
RESULTS: Across all databases, 16 high quality diagnostic accuracy studies were identified. In addition, multiple studies assessed the influence of multiple factors on diagnostic validity. In contrast to diagnostic validity studies, therapeutic efficacy trials were limited to a total of 14 randomized controlled trials, assessing the efficacy of intraarticular injections, facet or zygapophysial joint nerve blocks, and radiofrequency neurotomy of the innervation of the facet joints. The evidence for the diagnostic validity of lumbar facet joint nerve blocks with at least 75% pain relief with ability to perform previously painful movements was level I, based on a range of level I to V derived from a best evidence synthesis. For therapeutic interventions, the evidence was variable from level II to III, with level II evidence for lumbar facet joint nerve blocks and radiofrequency neurotomy for long-term improvement (greater than 6 mo), and level III evidence for lumbosacral zygapophysial joint injections for short-term improvement only.
CONCLUSION: This review provides significant evidence for the diagnostic validity of facet joint nerve blocks, and moderate evidence for therapeutic radiofrequency neurotomy and therapeutic facet joint nerve blocks in managing chronic low back pain.
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.
BACKGROUND: Radiofrequency (RF) denervation, an invasive treatment for chronic low back pain (CLBP), is used most often for pain suspected to arise from facet joints, sacroiliac (SI) joints or discs. Many (uncontrolled) studies have shown substantial variation in its use between countries and continued uncertainty regarding its effectiveness.
OBJECTIVES: The objective of this review is to assess the effectiveness of RF denervation procedures for the treatment of patients with CLBP. The current review is an update of the review conducted in 2003.
SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, three other databases, two clinical trials registries and the reference lists of included studies from inception to May 2014 for randomised controlled trials (RCTs) fulfilling the inclusion criteria. We updated this search in June 2015, but we have not yet incorporated these results.
SELECTION CRITERIA: We included RCTs of RF denervation for patients with CLBP who had a positive response to a diagnostic block or discography. We applied no language or date restrictions.
DATA COLLECTION AND ANALYSIS: Pairs of review authors independently selected RCTs, extracted data and assessed risk of bias (RoB) and clinical relevance using standardised forms. We performed meta-analyses with clinically homogeneous studies and assessed the quality of evidence for each outcome using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach.
MAIN RESULTS: In total, we included 23 RCTs (N = 1309), 13 of which (56%) had low RoB. We included both men and women with a mean age of 50.6 years. We assessed the overall quality of the evidence as very low to moderate. Twelve studies examined suspected facet joint pain, five studies disc pain, two studies SI joint pain, two studies radicular CLBP, one study suspected radiating low back pain and one study CLBP with or without suspected radiation. Overall, moderate evidence suggests that facet joint RF denervation has a greater effect on pain compared with placebo over the short term (mean difference (MD) -1.47, 95% confidence interval (CI) -2.28 to -0.67). Low-quality evidence indicates that facet joint RF denervation is more effective than placebo for function over the short term (MD -5.53, 95% CI -8.66 to -2.40) and over the long term (MD -3.70, 95% CI -6.94 to -0.47). Evidence of very low to low quality shows that facet joint RF denervation is more effective for pain than steroid injections over the short (MD -2.23, 95% CI -2.38 to -2.08), intermediate (MD -2.13, 95% CI -3.45 to -0.81), and long term (MD -2.65, 95% CI -3.43 to -1.88). RF denervation used for disc pain produces conflicting results, with no effects for RF denervation compared with placebo over the short and intermediate term, and small effects for RF denervation over the long term for pain relief (MD -1.63, 95% CI -2.58 to -0.68) and improved function (MD -6.75, 95% CI -13.42 to -0.09). Lack of evidence of short-term effectiveness undermines the clinical plausibility of intermediate-term or long-term effectiveness. When RF denervation is used for SI joint pain, low-quality evidence reveals no differences from placebo in effects on pain (MD -2.12, 95% CI -5.45 to 1.21) and function (MD -14.06, 95% CI -30.42 to 2.30) over the short term, and one study shows a small effect on both pain and function over the intermediate term. RF denervation is an invasive procedure that can cause a variety of complications. The quality and size of original studies were inadequate to permit assessment of how often complications occur.
AUTHORS' CONCLUSIONS: The review authors found no high-quality evidence suggesting that RF denervation provides pain relief for patients with CLBP. Similarly, we identified no convincing evidence to show that this treatment improves function. Overall, the current evidence for RF denervation for CLBP is very low to moderate in quality; high-quality evidence is lacking. High-quality RCTs with larger patient samples are needed, as are data on long-term effects.
BACKGROUND: Radiofrequency ablation (RFA), a procedure using heat to interrupt pain signals in spinal nerves, is an emerging treatment option for chronic low back pain. Its clinical efficacy has not yet been established.
OBJECTIVE: To determine the efficacy of RFA for chronic low back pain associated with lumbar facet joints, sacroiliac joints, discogenic low back pain and the coccyx.
METHODS: A systematic review was conducted. Medline, EMBASE, PubMed, SPORTDiscus, CINAHL and the Cochrane Library were searched up to August 2013. Abstracts and full-text articles were reviewed in duplicate. Included articles were sham-controlled randomized controlled trials (RCTs), assessed the efficacy of RFA, reported at least one month of follow-up and included participants who had experienced back pain for at least three months. Data were extracted in duplicate and quality was assessed using the Cochrane Risk of Bias tool. Due to heterogeneity, as well as a lack of reported mean differences and SDs, meta-analysis was not possible using these data.
RESULTS: The present systematic review retrieved 1063 abstracts. Eleven sham-controlled RCTs were included: three studies involving discogenic back pain; six studies involving lumbar facet joint pain; and two studies involving sacroiliac joint pain. No studies were identified assessing the coccyx. The evidence supports RFA as an efficacious treatment for lumbar facet joint and sacroiliac joint pain, with five of six and both of the RCTs demonstrating statistically significant pain reductions, respectively. The evidence supporting RFA for the treatment of discogenic pain is mixed.
CONCLUSIONS: While the majority of the studies focusing on lumbar facet joints and sacroiliac joints suggest that RFA significantly reduces pain in short-term follow-up, the evidence base for discogenic low back pain is mixed. There is no RCT evidence for RFA for the coccyx. Future studies should examine the clinical significance of the achieved pain reduction and the long-term efficacy of RFA.
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
BACKGROUND CONTEXT: Although numerous studies have been published, controversy still exists regarding fusion and nonsurgical treatment for symptomatic degenerative lumbar spine conditions. Definite conclusions are difficult to draw because of differences in patient inclusion criteria, fusion technique, nonoperative treatment regimen, and clinical outcome measures used to determine success.
PURPOSE: The objective of this study was to evaluate lumbar fusion and nonsurgical interventions for various degenerative spine disorders using the Oswestry Disability Index (ODI) as a primary outcome measure in a systematic review. A secondary objective was to determine whether there is a difference in clinical outcomes based on the specific diagnosis.
STUDY DESIGN/SETTING: Systematic review.
PATIENT SAMPLE: Patients with low back pain of at least 12 weeks duration and older than 18 years, with prospectively collected ODI scores and at least a 12-month follow-up.
OUTCOME MEASURES: ODI and Short Form-36 (SF-36).
METHODS: A MEDLINE, HealthSTAR, CINAHL, and Cochrane database search was done using the search strategy recommended by the Cochrane Back Review Group. Proceedings from annual meetings of various spine societies and reference lists from review articles and retrieved articles were evaluated for possible inclusion. Criteria for inclusion were prospective randomized clinical trials in patients with low back pain of at least 12 weeks duration and older than 18 years; with prospectively collected ODI scores and at least a 12-month follow-up. The methodological quality of the studies was assessed using the van Tulder criteria. Data extracted from each study included demographics, study design, diagnosis, baseline and change in ODI, and baseline and change in SF-36 Physical Composite Score (PCS). The data were pooled and analyzed based on the primary reported inclusion diagnosis: degenerative disc disease (DDD), chronic low back pain (CLBP), and spondylolisthesis; and treatment: fusion (unspecified, posterior, anterior, combined) and nonsurgical.
RESULTS: Twenty-five studies met the inclusion criteria. The distribution of sex and smokers was similar across diagnoses and treatments. Patients with spondylolisthesis were older than patients with DDD and CLBP. Patients with spondylolisthesis had the greatest ODI improvement followed by patients with DDD and CLBP. The three fusion types produced similar amounts of improvement in ODI. Nonsurgical patients did not improve as much but had a lower baseline ODI. Improvements in the SF-36 PCS were fairly consistent across diagnostic groups and treatment types.
CONCLUSIONS: Substantial improvement can be expected in patients treated with fusion, regardless of technique, when an established indication such as spondylolisthesis or DDD exists. CLBP patients are less disabled and experience less improvement.
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.
To investigate the diagnostic validity and therapeutic value of lumbar facet joint interventions in managing chronic low back pain.
METHODS:
The review process applied systematic evidence-based assessment methodology of controlled trials of diagnostic validity and randomized controlled trials of therapeutic efficacy. Inclusion criteria encompassed all facet joint interventions performed in a controlled fashion. The pain relief of greater than 50% was the outcome measure for diagnostic accuracy assessment of the controlled studies with ability to perform previously painful movements, whereas, for randomized controlled therapeutic efficacy studies, the primary outcome was significant pain relief and the secondary outcome was a positive change in functional status. For the inclusion of the diagnostic controlled studies, all studies must have utilized either placebo controlled facet joint blocks or comparative local anesthetic blocks. In assessing therapeutic interventions, short-term and long-term reliefs were defined as either up to 6 mo or greater than 6 mo of relief. The literature search was extensive utilizing various types of electronic search media including PubMed from 1966 onwards, Cochrane library, National Guideline Clearinghouse, clinicaltrials.gov, along with other sources including previous systematic reviews, non-indexed journals, and abstracts until March 2015. Each manuscript included in the assessment was assessed for methodologic quality or risk of bias assessment utilizing the Quality Appraisal of Reliability Studies checklist for diagnostic interventions, and Cochrane review criteria and the Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment tool for therapeutic interventions. Evidence based on the review of the systematic assessment of controlled studies was graded utilizing a modified schema of qualitative evidence with best evidence synthesis, variable from level I to level V.
RESULTS:
Across all databases, 16 high quality diagnostic accuracy studies were identified. In addition, multiple studies assessed the influence of multiple factors on diagnostic validity. In contrast to diagnostic validity studies, therapeutic efficacy trials were limited to a total of 14 randomized controlled trials, assessing the efficacy of intraarticular injections, facet or zygapophysial joint nerve blocks, and radiofrequency neurotomy of the innervation of the facet joints. The evidence for the diagnostic validity of lumbar facet joint nerve blocks with at least 75% pain relief with ability to perform previously painful movements was level I, based on a range of level I to V derived from a best evidence synthesis. For therapeutic interventions, the evidence was variable from level II to III, with level II evidence for lumbar facet joint nerve blocks and radiofrequency neurotomy for long-term improvement (greater than 6 mo), and level III evidence for lumbosacral zygapophysial joint injections for short-term improvement only.
CONCLUSION:
This review provides significant evidence for the diagnostic validity of facet joint nerve blocks, and moderate evidence for therapeutic radiofrequency neurotomy and therapeutic facet joint nerve blocks in managing chronic low back pain.
Systematic Review Question»Other systematic review or not clear
