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

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.


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