JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL

Patient Priority Weighting of the Roland Morris Disability Questionnaire Does Not Change Results of the Lumbar Epidural Steroid Injections for Spinal Stenosis Trial

Una E Makris, Todd C Edwards, Danielle C Lavallee, Zoya Bauer, Bryan A Comstock, Jeffrey G Jarvik, Donald L Patrick, Mahshid Lotfi, Janna L Friedly
Spine 2017 January 1, 42 (1): 42-48
27105466

STUDY DESIGN: Secondary analysis of lumbar epidural steroid injections for spinal stenosis randomized controlled trial data.

OBJECTIVE: To reevaluate whether outcomes for older adults receiving epidural steroid injections with or without corticosteroid improve after using patient-prioritized Roland-Morris Disability Questionnaire (RDQ) items.

SUMMARY OF BACKGROUND DATA: Epidural corticosteroid injections are commonly used to treat lumbar spinal stenosis symptoms, despite limited evidence for their effectiveness in clinical trials. It is unclear whether evaluating patient-prioritized outcomes would alter results of a large clinical trial.

METHODS: Outcomes from the trial of lumbar epidural corticosteroid injections for spinal stenosis (LESS) trial were reanalyzed using RDQ, Sickness Impact Profile (SIP) weights assigned to the RDQ items, and patient-prioritized RDQ items. Differences between corticosteroid + lidocaine versus lidocaine-alone groups and 95% confidence intervals (CI) were calculated using analysis of covariance with adjustment for baseline values of the RDQ and recruitment site.

RESULTS: At 6 weeks, both the corticosteroid + lidocaine group and the lidocaine-alone group had improvement in the RDQ scores (RDQ, RDQ using SIP weights, patient-prioritized RDQ) as compared with baseline scores (corticosteroid + lidocaine: -4.2 points, -4.1 points, -4.2; lidocaine-alone: -3.1 points, -2.9 points, and -3.1 points, respectively). However, there was no significant between-group difference in the RDQ or patient-prioritized RDQ (average treatment effect -1.0 points, 95% CI -2.1 to 0.1, P = 0.07; -1.0 points, 95% CI -2.0 to 0.1, P = 0.08, respectively). Although the between-group difference of RDQ using SIP weights was statistically significant (average treatment effect -1.1, 95% CI -2.2 to -0.1, P = 0.04), this was not clinically important.

CONCLUSION: Results of the LESS trial did not substantively differ based on reanalysis of data using RDQ with SIP weights or patient-prioritized RDQ outcomes. This provides additional evidence that epidural injection of corticosteroid + lidocaine offered minimal or no short-term benefit as compared with epidural injection of lidocaine alone for older adults with lumbar spinal stenosis.

LEVEL OF EVIDENCE: 2.

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