Interpreting Change Scores for Pain and Functional Status in Low Back Pain

Ostelo, Raymond; Deyo, R. A.; Stratford, Paul W.; Waddell, Gordon; Croft, Peter; Korff, Michael Von; Bouter, Lex M.; Vet, Henrica C.W. de

doi:10.1097/brs.0b013e31815e3a10

Cited by 1,573 publications

(736 citation statements)

References 27 publications

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“…The primary efficacy endpoint was a responder analysis where a “responder” was defined as a subject with ≥2‐point reduction in the mean NRS pain score 29 from baseline to 90 days postactivation without a clinically meaningful increase in consumption of back pain medications as determined and adjudicated by the CEC. For back pain assessments after 90 days, subjects were asked to report their low back pain NRS on the day of the evaluation (single day NRS).…”

Section: Methodsmentioning

confidence: 99%

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New Therapy for Refractory Chronic Mechanical Low Back Pain—Restorative Neurostimulation to Activate the Lumbar Multifidus: One Year Results of a Prospective Multicenter Clinical Trial

Deckers

Smedt

Mitchell³

et al. 2018

Neuromodulation: Technology at the Neural Interface

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ObjectivesThe purpose of the international multicenter prospective single arm clinical trial was to evaluate restorative neurostimulation eliciting episodic contraction of the lumbar multifidus for treatment of chronic mechanical low back pain (CMLBP) in patients who have failed conventional therapy and are not candidates for surgery or spinal cord stimulation (SCS).Materials and MethodsFifty‐three subjects were implanted with a neurostimulator (ReActiv8, Mainstay Medical Limited, Dublin, Ireland). Leads were positioned bilaterally with electrodes close to the medial branch of the L2 dorsal ramus nerve. The primary outcome measure was low back pain evaluated on a 10‐Point Numerical Rating Scale (NRS). Responders were defined as subjects with an improvement of at least the Minimal Clinically Important Difference (MCID) of ≥2‐point in low back pain NRS without a clinically meaningful increase in LBP medications at 90 days. Secondary outcome measures included Oswestry Disability Index (ODI) and Quality of Life (QoL; EQ‐5D).ResultsFor 53 subjects with an average duration of CLBP of 14 years and average NRS of 7 and for whom no other therapies had provided satisfactory pain relief, the responder rate was 58%. The percentage of subjects at 90 days, six months, and one year with ≥MCID improvement in single day NRS was 63%, 61%, and 57%, respectively. Percentage of subjects with ≥MCID improvement in ODI was 52%, 57%, and 60% while those with ≥MCID improvement in EQ‐5D was 88%, 82%, and 81%. There were no unanticipated adverse events (AEs) or serious AEs related to the device, procedure, or therapy. The initial surgical approach led to a risk of lead fracture, which was mitigated by a modification to the surgical approach.ConclusionsElectrical stimulation to elicit episodic lumbar multifidus contraction is a new treatment option for CMLBP. Results demonstrate clinically important, statistically significant, and lasting improvement in pain, disability, and QoL.

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Section: Methodsmentioning

confidence: 99%

“…QoL was measured with the European Quality of Life Score on Five Dimensions (EQ‐5D, EuroQol Group; https://euroqol.org/). The minimal clinically important difference (MCID) for ODI is a change of 10 points 29 and the MCID for EQ‐5D is a change of at least 0.03 points 31.…”

Section: Methodsmentioning

confidence: 99%

New Therapy for Refractory Chronic Mechanical Low Back Pain—Restorative Neurostimulation to Activate the Lumbar Multifidus: One Year Results of a Prospective Multicenter Clinical Trial

Deckers

Smedt

Mitchell³

et al. 2018

Neuromodulation: Technology at the Neural Interface

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“…1. When a disc problem was suspected (Table 1) and patients met the inclusion and exclusion criteria (New Zealand Low Back Pain Guide, 1997; Table 2), and if the test injection at the ramus communicans with local anaesthetics was positive [decrease in Numerical Rating Scale (NRS) of 2 or more on a 0–10 point scale (Ostelo et al., 2008)], the patient was eligible for the RCT. Each patient received a general brochure containing information concerning scientific research involving human subjects (Ministry of Health, Welfare and Sports) and a brochure (including the questionnaires) explaining the complete procedure.…”

Section: Methodsmentioning

confidence: 99%

Randomized sham‐controlled, double‐blind, multicenter clinical trial on the effect of percutaneous radiofrequency at the ramus communicans for lumbar disc pain

Tilburg

Stronks

Groeneweg

et al. 2016

European Journal of Pain

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BackgroundInvestigate the effect of percutaneous radiofrequency compared to a sham procedure, applied to the ramus communicans for treatment of lumbar disc pain.MethodsRandomized sham‐controlled, double‐blind, crossover, multicenter clinical trial. Multidisciplinary pain centres of two general hospitals. Sixty patients aged 18 or more with medical history and physical examination suggestive for lumbar disc pain and a reduction of two or more on a numerical rating scale (0–10) after a diagnostic ramus communicans test block. Treatment group: percutaneous radiofrequency treatment applied to the ramus communicans; sham: same procedure except radiofrequency treatment. Primary outcome measure: pain reduction. Secondary outcome measure: Global Perceived Effect.ResultsNo statistically significant difference in pain level over time between the groups, as well as in the group was found; however, the factor period yielded a statistically significant result. In the crossover group, 11 out of 16 patients experienced a reduction in NRS of 2 or more at 1 month (no significant deviation from chance). No statistically significant difference in satisfaction over time between the groups was found. The independent factors group and period also showed no statistically significant effects. The same applies to recovery: no statistically significant effects were found.ConclusionsThe null hypothesis of no difference in pain reduction and in Global Perceived Effect between the treatment and sham group cannot be rejected. Post hoc analysis revealed that none of the investigated parameters contributed to the prediction of a significant pain reduction.SignificanceInterrupting signalling through the ramus communicans may interfere with the transition of painful information from the discs to the central nervous system. Methodological differences exist in studies evaluating the efficacy of radiofrequency treatment for lumbar disc pain. A randomized, sham‐controlled, double‐blind, multicenter clinical trial on the effect of radiofrequency at the ramus communicans for lumbar disc pain was conducted. The null hypothesis of no difference in pain reduction and in Global Perceived Effect between the treatment and sham group cannot be rejected.

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“…We analysed outcomes of included studies using a randomeffects model. We adopted the definition of a minimal clinically important difference [20]. We defined the minimal clinically important difference of the primary outcome measures (i.e.…”

Section: Measures Of Treatment Effectmentioning

confidence: 99%

Effectiveness of posterior decompression techniques compared with conventional laminectomy for lumbar stenosis

et al. 2015

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Purpose To compare the effectiveness of techniques of posterior decompression that limit the extent of bony decompression or to avoid removal of posterior midline structures of the lumbar spine versus conventional facetpreserving laminectomy for the treatment of patients with degenerative lumbar stenosis. Methods A comprehensive electronic search of the Cochrane Central Register of Controlled Trials, MED-LINE, EMBASE, Web of Science, and the clinical trials registries ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform was conducted for relevant literature up to June 2014. Results A total of four high-quality RCTs and six lowquality RCTs met the search criteria of this review. These studies included a total of 733 participants. Three different techniques that avoid removal of posterior midline structures are compared to conventional laminectomy; unilateral laminotomy for bilateral decompression, bilateral laminotomy and split-spinous process laminotomy. Evidence of low or very low quality suggests that different techniques of posterior decompression and conventional laminectomy have similar effects on functional disability and leg pain. Only perceived recovery at final follow-up was better in patients that underwent bilateral laminotomy compared with conventional laminectomy. Unilateral laminotomy for bilateral decompression and bilateral laminotomy resulted in numerically fewer cases of iatrogenic instability, although in both cases, the incidence of instability was low. The difference in severity of postoperative low back pain following bilateral laminotomy and split-spinous process laminotomy was significantly less, but was too small to be clinically important. We found no evidence to show that the incidence of complications, length of the procedure, length of hospital stay and postoperative walking distance differed between techniques of posterior decompression. Conclusion The evidence provided by this systematic review for the effects of unilateral laminotomy for bilateral decompression, bilateral laminotomy and split-spinous process laminotomy compared with conventional laminectomy on functional disability, perceived recovery and leg pain is of low or very low quality. Therefore, further research is necessary to establish whether these techniques provide a safe and effective alternative for conventional laminectomy. Proposed advantages of these techniques regarding the incidence of iatrogenic instability and postoperative back pain are plausible, but definitive conclusions are limited by poor methodology and poor reporting of outcome measures among included studies.

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Interpreting Change Scores for Pain and Functional Status in Low Back Pain

Cited by 1,573 publications

References 27 publications

New Therapy for Refractory Chronic Mechanical Low Back Pain—Restorative Neurostimulation to Activate the Lumbar Multifidus: One Year Results of a Prospective Multicenter Clinical Trial

New Therapy for Refractory Chronic Mechanical Low Back Pain—Restorative Neurostimulation to Activate the Lumbar Multifidus: One Year Results of a Prospective Multicenter Clinical Trial

Randomized sham‐controlled, double‐blind, multicenter clinical trial on the effect of percutaneous radiofrequency at the ramus communicans for lumbar disc pain

Effectiveness of posterior decompression techniques compared with conventional laminectomy for lumbar stenosis

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