Dataset Information

Responsiveness of Outcome Measures in Nonsurgical Patients with Lumbar Spinal Stenosis: A Secondary Analysis From a Randomized Controlled Trial.

ABSTRACT:

Study design

Secondary analysis from a randomized controlled trial on nonsurgical interventions for patients with lumbar spinal stenosis (LSS).

Objective

The aim of this study was to assess the responsiveness of the Self-Paced Walking Test (SPWT), Swiss Spinal Stenosis Questionnaire (SSS), and Oswestry Disability Index (ODI) and determine their minimal clinically important differences (MCID) in nonsurgical LSS patients.

Summary of background data

Limited information is available about the responsiveness of these tests in nonsurgical LSS population.

Methods

A total of 180 participants completed the SPWT, SSS, and ODI at baseline, 2, and 6 months. Responsiveness was assessed by distribution-based method, including effect size and standardized response mean, and anchor-based method, using the patient global index of change (PGIC) as the external anchor to distinguish responders and non-responders. Areas under the curve (AUC) were calculated along with MCIDs for "minimal" and "moderate improvement" subgroups.

Results

The following values represent 2- and 6-month analyses of each outcome measure, respectively. Standard effect sizes: 0.48 and 0.50 for SPWT, -0.42 and -0.36 for SSS, and -0.29 and -0.25 for ODI. Spearman correlation coefficients between PGIC and outcomes were: 0.44 and 0.39 for SPWT, -0.53 and -0.55 for SSS, and -0.46 and -0.54 for ODI. MCIDs for the "minimal improvement" subgroup were: 375.9 and 319.3 ms for SPWT, -5.3 and -5.8 points for SSS, and -9.3 and -10.8 points for ODI. AUCs was 0.68 to 0.76. MCIDs for the "moderate improvement" subgroup were: 344.2 and 538.2 m for SPWT, -5.5 and -7.5 points for SSS, and -9.1 and -13.6 points for ODI. AUCs ranged from 0.68 to 0.76.

Conclusion

The SPWT, SSS, and ODI are responsive outcome measures to assess nonsurgical patients with LSS. This finding, along with the reported MCIDs, can help clinicians to monitor changes in their patients' walking and physical function over time and make clinical decisions. They also provide researchers with reference for future studies in LSS.Level of Evidence: 2.

SUBMITTER: Carlesso C

PROVIDER: S-EPMC8154167 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:Importance:Lumbar spinal stenosis (LSS) is the most common reason for spine surgery in older US adults. There is an evidence gap about nonsurgical LSS treatment options. Objective:To explore the comparative clinical effectiveness of 3 nonsurgical interventions for patients with LSS. Design, Setting, and Participants:Three-arm randomized clinical trial of 3 years' duration (November 2013 to June 2016). Analysis began in August 2016. All interventions were delivered during 6 weeks with follow-up at 2 months and 6 months at an outpatient research clinic. Patients older than 60 years with LSS were recruited from the general public. Eligibility required anatomical evidence of central canal and/or lateral recess stenosis (magnetic resonance imaging/computed tomography) and clinical symptoms associated with LSS (neurogenic claudication; less symptoms with flexion). Analysis was intention to treat. Interventions:Medical care, group exercise, and manual therapy/individualized exercise. Medical care consisted of medications and/or epidural injections provided by a physiatrist. Group exercise classes were supervised by fitness instructors in senior community centers. Manual therapy/individualized exercise consisted of spinal mobilization, stretches, and strength training provided by chiropractors and physical therapists. Main Outcomes and Measures:Primary outcomes were between-group differences at 2 months in self-reported symptoms and physical function measured by the Swiss Spinal Stenosis questionnaire (score range, 12-55) and a measure of walking capacity using the self-paced walking test (meters walked for 0 to 30 minutes). Results:A total of 259 participants (mean [SD] age, 72.4 [7.8] years; 137 women [52.9%]) were allocated to medical care (88 [34.0%]), group exercise (84 [32.4%]), or manual therapy/individualized exercise (87 [33.6%]). Adjusted between-group analyses at 2 months showed manual therapy/individualized exercise had greater improvement of symptoms and physical function compared with medical care (-2.0; 95% CI, -3.6 to -0.4) or group exercise (-2.4; 95% CI, -4.1 to -0.8). Manual therapy/individualized exercise had a greater proportion of responders (?30% improvement) in symptoms and physical function (20%) and walking capacity (65.3%) at 2 months compared with medical care (7.6% and 48.7%, respectively) or group exercise (3.0% and 46.2%, respectively). At 6 months, there were no between-group differences in mean outcome scores or responder rates. Conclusions and Relevance:A combination of manual therapy/individualized exercise provides greater short-term improvement in symptoms and physical function and walking capacity than medical care or group exercises, although all 3 interventions were associated with improvements in long-term walking capacity. Trial Registration:ClinicalTrials.gov Identifier: NCT01943435.

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:Epidural injections of anesthetic with or without steroids are widely used for treating lumbar spinal stenosis, a common cause of chronic low back pain, but there is a lack of rigorous data comparing the effectiveness of epidural injections of anesthetic with and without steroids. This meta-analysis presents a current, comprehensive picture of how epidural injections of anesthetic with steroids compare with those using local anesthetic alone.PubMed, Embase, Web of Science, and Cochrane Library databases were searched from their inception through February 5, 2015. Weight mean difference, risk ratio, and 95% confidence intervals were calculated. A random effects model or fixed effects model was used to pool the estimates, according to the heterogeneity between the included studies.We included 13 randomized controlled trials, involving 1,465 patients. Significant pain relief (?50%) was demonstrated in 53.7% of patients administered with epidural injections of anesthetic with steroids (group 1) and in 56.4% of those administered with local anesthetic alone (group 2). Patients showed a reduction in numeric rating scale pain score of 3.7 and 3.6 in the two groups, respectively. Significant functional improvement was achieved in 65.2% of patients in group 1 and 63.1% of patients in group 2, with Oswestry Disability Index reductions of 13.8 and 14.5 points, respectively. The overall number of injections per year was 3.2±1.3 and 3.4±1.2 with average total relief per year of 29.3±19.7 and 33.8±19.3 weeks, respectively. The opioid intakes decreased from baseline by 12.4 and 7.8 mg, respectively. Among the outcomes listed, only total relief time differed significantly between the two groups.Both epidural injections with steroids or with local anesthetic alone provide significant pain relief and functional improvement in managing chronic low back pain secondary to lumbar spinal stenosis, and the inclusion of steroids confers no advantage compared to local anesthetic alone.