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

ABSTRACT: Secondary analysis of lumbar epidural steroid injections for spinal stenosis randomized controlled trial data.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.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.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.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.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.2.

SUBMITTER: Makris UE

PROVIDER: S-EPMC5071103 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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

Makris Una E UE Edwards Todd C TC Lavallee Danielle C DC Bauer Zoya Z Comstock Bryan A BA Jarvik Jeffrey G JG Patrick Donald L DL Lotfi Mahshid M Friedly Janna L JL

Spine 20170101 1

<h4>Study design</h4>Secondary analysis of lumbar epidural steroid injections for spinal stenosis randomized controlled trial data.<h4>Objective</h4>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.<h4>Summary of background data</h4>Epidural corticosteroid injections are commonly used to treat lumbar spinal stenosis symptoms, despite limit ...[more]

PMID: 27105466

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Project description:BackgroundLumbar spinal stenosis is one of the most common causes of low back pain among older adults and can cause significant disability. Despite its prevalence, treatment of spinal stenosis symptoms remains controversial. Epidural steroid injections are used with increasing frequency as a less invasive, potentially safer, and more cost-effective treatment than surgery. However, there is a lack of data to judge the effectiveness and safety of epidural steroid injections for spinal stenosis. We describe our prospective, double-blind, randomized controlled trial that tests the hypothesis that epidural injections with steroids plus local anesthetic are more effective than epidural injections of local anesthetic alone in improving pain and function among older adults with lumbar spinal stenosis.MethodsWe will recruit up to 400 patients with lumbar central canal spinal stenosis from at least 9 clinical sites over 2 years. Patients with spinal instability who require surgical fusion, a history of prior lumbar surgery, or prior epidural steroid injection within the past 6 months are excluded. Participants are randomly assigned to receive either ESI with local anesthetic or the control intervention (epidural injections with local anesthetic alone). Subjects receive up to 2 injections prior to the primary endpoint at 6 weeks, at which time they may choose to crossover to the other intervention.Participants complete validated, standardized measures of pain, functional disability, and health-related quality of life at baseline and at 3 weeks, 6 weeks, and 3, 6, and 12 months after randomization. The primary outcomes are Roland-Morris Disability Questionnaire and a numerical rating scale measure of pain intensity at 6 weeks. In order to better understand their safety, we also measure cortisol, HbA1c, fasting blood glucose, weight, and blood pressure at baseline, and at 3 and 6 weeks post-injection. We also obtain data on resource utilization and costs to assess cost-effectiveness of epidural steroid injection.DiscussionThis study is the first multi-center, double-blind RCT to evaluate the effectiveness of epidural steroid injections in improving pain and function among older adults with lumbar spinal stenosis. The study will also yield data on the safety and cost-effectiveness of this procedure for older adults.Trial registrationClinicaltrials.gov NCT01238536.

Project description:Among the multiple causes of chronic low back pain, axial and discogenic pain are common. Various modalities of treatments are utilized in managing discogenic and axial low back pain including epidural injections. However, there is a paucity of evidence regarding the effectiveness, indications, and medical necessity of any treatment modality utilized for managing axial or discogenic pain, including epidural injections. In an interventional pain management practice in the US, a randomized, double-blind, active control trial was conducted. The objective was to assess the effectiveness of lumbar interlaminar epidural injections of local anesthetic with or without steroids for managing chronic low back pain of discogenic origin. However, disc herniation, radiculitis, facet joint pain, or sacroiliac joint pain were excluded. Two groups of patients were studied, with 60 patients in each group receiving either local anesthetic only or local anesthetic mixed with non-particulate betamethasone. Primary outcome measures included the pain relief-assessed by numeric rating scale of pain and functional status assessed by the, Oswestry Disability Index, Secondary outcome measurements included employment status, and opioid intake. Significant improvement or success was defined as at least a 50% decrease in pain and disability. Significant improvement was seen in 77% of the patients in Group I and 67% of the patients in Group II. In the successful groups (those with at least 3 weeks of relief with the first two procedures), the improvement was 84% in Group I and 71% in Group II. For those with chronic function-limiting low back pain refractory to conservative management, it is concluded that lumbar interlaminar epidural injections of local anesthetic with or without steroids may be an effective modality for managing chronic axial or discogenic pain. This treatment appears to be effective for those who have had facet joints as well as sacroiliac joints eliminated as the pain source.

Project description:Background and purposeThe Patient Reported Outcomes Measurement Information System is a newly developed outcomes measure promulgated by the National Institutes of Health. This study compares changes in pain and physical function-related measures of this system with changes on the Numeric Rating Pain Scale, Roland Morris Disability Index, and the European Quality of Life scale 5D questionnaire in patients undergoing transformational epidural steroid injections for radicular pain.Materials and methodsOne hundred ninety-nine patients undergoing transforaminal epidural steroid injections for radicular pain were enrolled in the study. Before the procedure, they rated the intensity of their pain by using the 0-10 Numeric Rating Pain Scale, Roland Morris Disability Index, and European Quality of Life scale 5D questionnaire. Patients completed the Patient Reported Outcomes Measurement Information System Physical Function, Pain Behavior, and Pain Interference short forms before transforaminal epidural steroid injections and at 3 and 6 months. Seventy and 43 subjects replied at 3- and 6-month follow-up. Spearman rank correlations were used to assess the correlation between the instruments. The minimally important differences were calculated for each measurement tool as an indicator of meaningful change.ResultsAll instruments were responsive in detecting changes at 3- and 6-month follow-up (P < .0001). There was significant correlation between changes in Patient Reported Outcomes Measurement Information System scores and legacy questionnaires from baseline to 3 months (P < .05). There were, however, no significant correlations in changes from 3 to 6 months with any of the instruments.ConclusionsThe studied Patient Reported Outcomes Measurement Information System domains offered responsive and correlative psychometric properties compared with legacy instruments in a population of patients undergoing transforaminal epidural steroid injections for radicular pain.

Project description:Importance:Endoscopic dilation is the mainstay treatment strategy for subglottic and proximal tracheal stenosis (SGS/PTS). Its major limitation is restenosis requiring repeated surgery. Intralesional steroid injection (ISI) is a promising adjunctive treatment aimed at prolonging the effects of dilation. Objective:To evaluate the association of serial in-office ISI after endoscopic dilation with surgery-free interval (SFI) in adults with SGS/PTS. Design, Setting, and Participants:A retrospective study of adults with SGS/PTS who underwent at least 2 consecutive in-office ISI at the University of Southern California, Keck School of Medicine, over a 3-year period was conducted. Exposure:Serial ISI with triamcinolone 40 mg/mL using topical anesthesia, spaced 3 to 6 weeks apart. Main Outcomes and Measures:Surgery-free interval, number of dilations, need for open airway surgery, decannulation rate, and adverse events. Patients with previous dilations and sufficient follow-up time were included in a comparative analysis of SFI before and after ISI. The Mann-Whitney U test was applied for comparisons. Results:Twenty-four patients met eligibility criteria. Mean (SD) age was 50.1 (15.1) years; 18 (75%) were female. Ten (42%) patients had idiopathic, 8 (33%) had traumatic, and 6 (25%) had rheumatologic-related SGS/PTS. Mean (SD) follow-up time was 32.3 (33.4) months. Patients underwent mean (SD) 4.08 (1.91) injections. Seventeen (71%) patients have not undergone further surgery after ISI. Mean (SD) SFI was 17.8 (12.8) months overall and was 15.7 (10.6) months for idiopathic, 13.8 (9.9) for traumatic, and 26.7 (16.9) for rheumatologic-related SGS/PTS. Twenty-one (88%) patients underwent dilation(s) prior to ISI. Among patients who fulfilled eligibility criteria for comparison of SFI before and after ISI, SFI improved from 10.1 months before, to 22.6 months after ISI (mean difference, 12.5 months; 95% CI, -2.1 to 27.2 months). Three of 6 patients (all with traumatic SGS/PTS) presenting with a tracheotomy were decannulated. No patients required open airway surgery after ISI. There were no adverse events associated with ISI. Conclusions and Relevance:Serial in-office ISI are safe and well-tolerated in adults with SGS/PTS. This technique can reduce the surgical burden on these patients and may obviate the need for future airway intervention.

Dataset Information

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

Publications

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

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