Evidence versus advocacy, as related to radiofrequency denervation in the treatment of chronic low back pain and the MINT trials

2019 ◽  
Vol 45 (1) ◽  
pp. 79-83 ◽  
Author(s):  
William L Lanier ◽  
Joseph M Neal

In 2017, JAMA: Journal of the American Medical Association published the results of the MINT trials, prospective research involving 681 patients, all of whom received exercise therapy for low back pain. Half of the patients were randomized to additionally receive radiofrequency denervation (RFD) treatment. 88% of patients completed the 3-month follow-up, and 77% completed the 12-month follow-up. In this context, RFD provided no added benefit over the baseline of exercise therapy. In 2018, five authors, all experts in pain medicine, published a ‘Daring Discourse’ article in the journal Regional Anesthesia and Pain Medicine (RAPM), criticizing the findings of the MINT trials. Although 3 of the 5 authors of the RAPM ‘Daring Discourse’ article reported in conflict of interest statements—as is appropriate—that they were consultants to corporations that produce RFD equipment, the authors failed to disclose that 4 of 5 are on the editorial board of RAPM and all 5 are current officers in the medical organization that owns RAPM: that is, the American Society of Regional Anesthesia and Pain Medicine. Noteworthy, there was no published response from the MINT trial investigators to the Daring Discourse criticisms, either in the aforementioned example or in downstream venues where some of the same Daring Discourse authors continued their widely disseminated criticisms of the JAMA/MINT trials report. We believe that these actions taken by the Daring Discourse authors and RAPM have unfairly tipped the scales in the evaluation and application of RFD treatment of low back pain. In our commentary, we discuss: (1) the challenges associated with using clinical trials to predict clinical efficacy, (2) appropriate and inappropriate uses of postpublication commentary on original research findings, (3) the use of inappropriate commentary (and related means) to alter clinical practice in the presence of contradictory research findings, and (4) potential conflicts of interest related to the authors’ and Journal’s publication of the unopposed MINT trials criticism.

2007 ◽  
Vol 2;10 (3;2) ◽  
pp. 291-299
Author(s):  
Michael Gofeld

Background: Evidence for the efficacy of zygapophysial joint nerve radiofrequency neurotomy has remained controversial. Two randomized controlled trials showed positive results, but two others demonstrated no benefit. One carefully performed prospective trial confirmed high efficacy and lasting pain relief after the procedure; however, selection criteria for this study were superfluous, which resulted in a small number of patients available for follow up. Objectives: A large clinical audit with routine patient selection and use of appropriate technique was undertaken to determine the effect of radiofrequency neurotomy of the lumbar facet joints for relief of chronic low back pain. Design: Prospective clinical audit for quality was conducted in the pain clinic affiliated with a tertiary care teaching hospital. Setting: An interventional pain management setting in Canada. Methods: All patients with low back pain of more than 6 months’ duration, with or without non-radicular radiation to the buttock, hip, and leg were included. From January 1991 to December 2000, eligible patients underwent standardized diagnostic work-up, which included a self-reported pain questionnaire, physical examination, review of imaging studies, and diagnostic blockades. Those with an appropriate response to comparative double diagnostic blocks underwent standardized radiofrequency denervation of the lumbar zygapophysial joints. Patients were asked to estimate total perceived pain reduction (on a scale from 0% to 100%) at 6 weeks and at 6, 12, and 24 months after the procedure. Results: Of the 209 patients, 174 completed the study, and 35 were lost to follow-up or did not provide complete data for assessment. Of the 174 patients with complete data, 55 (31.6%) experienced no benefit from the procedure. One hundred and nineteen patients (68.4%) had good (> 50%) to excellent (> 80%) pain relief lasting from 6 to 24 months. Conclusion: This large, prospective clinical audit indicates that proper patient selection and anatomically correct radiofrequency denervation of the lumbar zygapophysial joints provide long-term pain relief in a routine clinical setting. Key words: low back pain, lumbar zygapophysial joint, radiofrequency denervation, clinical audit


2019 ◽  
Vol 54 (21) ◽  
pp. 1277-1278 ◽  
Author(s):  
Jill A Hayden ◽  
Maria N Wilson ◽  
Samuel Stewart ◽  
Jennifer L Cartwright ◽  
Andrea O Smith ◽  
...  

BackgroundLow back pain is one of the leading causes of disability worldwide. Exercise therapy is widely recommended to treat persistent non-specific low back pain. While evidence suggests exercise is, on average, moderately effective, there remains uncertainty about which individuals might benefit the most from exercise.MethodsIn parallel with a Cochrane review update, we requested individual participant data (IPD) from high-quality randomised clinical trials of adults with our two primary outcomes of interest, pain and functional limitations, and calculated global recovery. We compiled a master data set including baseline participant characteristics, exercise and comparison characteristics, and outcomes at short-term, moderate-term and long-term follow-up. We conducted descriptive analyses and one-stage IPD meta-analysis using multilevel mixed-effects regression of the overall treatment effect and prespecified potential treatment effect modifiers.ResultsWe received IPD for 27 trials (3514 participants). For studies included in this analysis, compared with no treatment/usual care, exercise therapy on average reduced pain (mean effect/100 (95% CI) −10.7 (−14.1 to –7.4)), a result compatible with a clinically important 20% smallest worthwhile effect. Exercise therapy reduced functional limitations with a clinically important 23% improvement (mean effect/100 (95% CI) −10.2 (−13.2 to –7.3)) at short-term follow-up. Not having heavy physical demands at work and medication use for low back pain were potential treatment effect modifiers—these were associated with superior exercise outcomes relative to non-exercise comparisons. Lower body mass index was also associated with better outcomes in exercise compared with no treatment/usual care. This study was limited by inconsistent availability and measurement of participant characteristics.ConclusionsThis study provides potentially useful information to help treat patients and design future studies of exercise interventions that are better matched to specific subgroups.Protocol publicationhttps://doi.org/10.1186/2046-4053-1-64


2018 ◽  
Vol 1 (1) ◽  
pp. 1
Author(s):  
Wawan Mulyawan ◽  
Yudi Yuwono Wiwoho ◽  
Syaiful Ichwan

Background: Following surgical treatments for low back pain, lower extremity pain or neurologic symptoms would last or recur, this is defined as failed sack surgery syndrome (FBSS). FBSS usually occurs in 5-40% of these surgical patients. The most common cause is an epidural scar adhesion. Percutaneous epidural neuroplasty is the non-mechanical treatment for this condition. Previously, the use of hyaluronidase and hypertonic saline separately is commonly used for epidurolysis but the combination of hyaluronidase and hypertonic saline 3% has not been explored.Objective: To investigate the two-year outcomes of percutaneous epidural neuroplasty using a combination of hyaluronidase and hypertonic saline 3% in patients with FBSS.Methods: Twelve patients who experience low back pain, with or without radiculopathy, who have underwent lumbar spine surgery previously were assigned to the study. Parameters, such as the visual analogue scale scores for the back (VAS-B) and legs (VAS-L), and the Oswestry disability index (ODI), were recorded and compared between pretreatment, 1 week, 1 month, 3 months, 1 year and 2 years follow-up.Results: For all 12 patients, the postoperative VAS-B, VAS-L, and ODI were significantly different from the preoperative values in all follow-up periods: 1 month, 3 months, 1 year, and 2 years.Conclusion: Based off this study group, percutaneous epidural neuroplasty using a combination of hyaluronidase and hypertonic saline 3% has a favourable outcome in the 2 years follow-up


Author(s):  
Le Ge ◽  
Chuhuai Wang ◽  
Haohan Zhou ◽  
Qiuhua Yu ◽  
Xin Li

Abstract Background Research suggests that individuals with low back pain (LBP) may have poorer motor control compared to their healthy counterparts. However, the sample population of almost 90% of related articles are young and middle-aged people. There is still a lack of a systematic review about the balance performance of elderly people with low back pain. This study aimed to conduct a systematic review and meta-analysis to understand the effects of LBP on balance performance in elderly people. Methods This systematic review and meta-analysis included a comprehensive search of PubMed, Embase, and Cochrane Library databases for full-text articles published before January 2020. We included the articles that 1) investigated the elderly people with LBP; 2) assessed balance performance with any quantifiable clinical assessment or measurement tool and during static or dynamic activity; 3) were original research. Two independent reviewers screened the relevant articles, and disagreements were resolved by a third reviewer. Results Thirteen case-control studies comparing balance performance parameters between LBP and healthy subjects were included. The experimental group (LBP group) was associated with significantly larger area of centre of pressure movement (P < 0.001), higher velocity of centre of pressure sway in the anteroposterior and mediolateral directions (P = 0.01 and P = 0.02, respectively), longer path length in the anteroposterior direction (P < 0.001), slower walking speed (P = 0.05), and longer timed up and go test time (P = 0.004) than the control group. Conclusion The results showed that balance performance was impaired in elderly people with LBP. We should pay more attention to the balance control of elderly people with LBP.


2013 ◽  
Vol 93 (12) ◽  
pp. 1603-1614 ◽  
Author(s):  
Karin Verkerk ◽  
Pim A.J. Luijsterburg ◽  
Martijn W. Heymans ◽  
Inge Ronchetti ◽  
Annelies L. Pool-Goudzwaard ◽  
...  

Background Few data are available on the course of and predictors for disability in patients with chronic nonspecific low back pain (CNSLBP). Objective The purpose of this study was to describe the course of disability and identify clinically important prognostic factors of low-back-pain–specific disability in patients with CNSLBP receiving multidisciplinary therapy. Design A prospective cohort study was conducted. Methods A total of 1,760 patients with CNSLBP who received multidisciplinary therapy were evaluated for their course of disability and prognostic factors at baseline and at 2-, 5-, and 12-month follow-ups. Recovery was defined as 30% reduction in low back pain–specific disability at follow-up compared with baseline and as absolute recovery if the score on the Quebec Back Pain Disability Scale (QBPDS) was ≤20 points at follow-up. Potential prognostic factors were identified using multivariable logistic regression analysis. Results Mean patient-reported disability scores on the QBPDS ranged from 51.7 (SD=15.6) at baseline to 31.7 (SD=15.2), 31.1 (SD=18.2), and 29.1 (SD=20.0) at 2, 5, and 12 months, respectively. The prognostic factors identified for recovery at 5 and 12 months were younger age and high scores on disability and on the 36-Item Short-Form Health Survey (SF-36) (Physical and Mental Component Summaries) at baseline. In addition, at 5-month follow-up, a shorter duration of complaints was a positive predictor, and having no comorbidity and less pain at baseline were additional predictors at 12-month follow-up. Limitations Missing values at 5- and 12-month follow-ups were 11.1% and 45.2%, respectively. Conclusion After multidisciplinary treatment, the course of disability in patients with CNSLBP continued to decline over a 12-month period. At 5- and 12-month follow-ups, prognostic factors were identified for a clinically relevant decrease in disability scores on the QBPDS.


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