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

Abstract

Study Design Secondary analysis of Lumbar Epidural steroid injections for Spinal Stenosis randomized controlled trial data. Objective To re-evaluate 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 LESS trial were re-analyzed 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). While 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. Conclusions Results of the LESS trial did not substantively differ based on re-analysis 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.

Epidural Steroid Injections for Low Back Pain: A Narrative Review

“…Moreover, some other studies did not find any significant improvement in symptoms or quality of life after an ESI for the treatment of LSS [ 67 , 68 , 69 , 70 ]. Tran et al wrote a review regarding the nonsurgical treatment of LSS and concluded that the literature could provide only limited evidence to formulate recommendations pertaining to the nonsurgical treatment of LSS [ 71 ].…”

Global Trends of Researches on Lumbar Spinal Stenosis

“…Old age was an independent risk factor for LSS and its relevant surgery, and cardiopulmonary insufficiency had always been the biggest obstacle to the operation of elderly patients. Most of the elderly patients are accompanied by chronic diseases such as hypertension, coronary heart disease and diabetes, which made the treatment situation complicated 19–21. The elderly’s energy status was gradually applied in clinical practice as an independent factor to predict the risk of surgery while the research on it was increasingly deep.…”

“…Most of the elderly patients are accompanied by chronic diseases such as hypertension, coronary heart disease and diabetes, which made the treatment situation complicated. [19][20][21] The elderly's energy status was gradually applied in clinical practice as an independent factor to predict the risk of surgery while the research on it was increasingly deep. Although increasing decompression and fusion surgeries were applied to the treatment of LSS to minimize the potential risk of future spinal instability and deformity, the merits of various decompression methods were still controversial, and there was no evidence to show that a certain decompression method or range was the most effective.…”

Non-operative treatment for lumbar spinal stenosis with neurogenic claudication: an updated systematic review

“…The improved outcomes at 3 weeks were statistically significant but not considered to be of clinical importance. 63 A follow-up subgroup analysis 64 using patient-prioritised Roland-Morris Disability Questionnaire items did not change the results. A total 21.5% of patients in the glucocorticoid-lidocaine group and 15.5% in the lidocaine alone group reported one or more adverse events (p=0.08).…”