Dataset Information

Surgery versus nonsurgical treatment of lumbar spinal stenosis: a randomized trial.

ABSTRACT:

Background

Primary care management decisions for patients with symptomatic lumbar spinal stenosis (LSS) are challenging, and nonsurgical guidance is limited by lack of evidence.

Objective

To compare surgical decompression with physical therapy (PT) for LSS and evaluate sex differences.

Design

Multisite randomized, controlled trial. (ClinicalTrials.gov: NCT00022776).

Setting

Neurologic and orthopedic surgery departments and PT clinics.

Participants

Surgical candidates with LSS aged 50 years or older who consented to surgery.

Intervention

Surgical decompression or PT.

Measurements

Primary outcome was physical function score on the Short Form-36 Health Survey at 2 years assessed by masked testers.

Results

The study took place from November 2000 to September 2007. A total of 169 participants were randomly assigned and stratified by surgeon and sex (87 to surgery and 82 to PT), with 24-month follow-up completed by 74 and 73 participants in the surgery and PT groups, respectively. Mean improvement in physical function for the surgery and PT groups was 22.4 (95% CI, 16.9 to 27.9) and 19.2 (CI, 13.6 to 24.8), respectively. Intention-to-treat analyses revealed no difference between groups (24-month difference, 0.9 [CI, -7.9 to 9.6]). Sensitivity analyses using causal-effects methods to account for the high proportion of crossovers from PT to surgery (57%) showed no significant differences in physical function between groups.

Limitation

Without a control group, it is not possible to judge success attributable to either intervention.

Conclusion

Surgical decompression yielded similar effects to a PT regimen among patients with LSS who were surgical candidates. Patients and health care providers should engage in shared decision-making conversations that include full disclosure of evidence involving surgical and nonsurgical treatments for LSS.

Primary funding source

National Institutes of Health and National Institute of Arthritis and Musculoskeletal and Skin Diseases.

SUBMITTER: Delitto A

PROVIDER: S-EPMC6252248 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Surgery versus nonsurgical treatment of lumbar spinal stenosis: a randomized trial.

Delitto Anthony A Piva Sara R SR Moore Charity G CG Fritz Julie M JM Wisniewski Stephen R SR Josbeno Deborah A DA Fye Mark M Welch William C WC

Annals of internal medicine 20150401 7

<h4>Background</h4>Primary care management decisions for patients with symptomatic lumbar spinal stenosis (LSS) are challenging, and nonsurgical guidance is limited by lack of evidence.<h4>Objective</h4>To compare surgical decompression with physical therapy (PT) for LSS and evaluate sex differences.<h4>Design</h4>Multisite randomized, controlled trial. (ClinicalTrials.gov: NCT00022776).<h4>Setting</h4>Neurologic and orthopedic surgery departments and PT clinics.<h4>Participants</h4>Surgical can ...[more]

PMID: 25844995

Similar Datasets

Project description:ImportanceLumbar 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.ObjectiveTo explore the comparative clinical effectiveness of 3 nonsurgical interventions for patients with LSS.Design, setting, and participantsThree-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.InterventionsMedical 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 measuresPrimary 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).ResultsA 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 relevanceA 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 registrationClinicalTrials.gov Identifier: NCT01943435.

Project description:Study designSecondary analysis from a randomized controlled trial on nonsurgical interventions for patients with lumbar spinal stenosis (LSS).ObjectiveThe 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 dataLimited information is available about the responsiveness of these tests in nonsurgical LSS population.MethodsA 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.ResultsThe 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.ConclusionThe 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.

Project description:BackgroundManagement of degenerative spondylolisthesis with spinal stenosis is controversial. Surgery is widely used, but its effectiveness in comparison with that of nonsurgical treatment has not been demonstrated in controlled trials.MethodsSurgical candidates from 13 centers in 11 U.S. states who had at least 12 weeks of symptoms and image-confirmed degenerative spondylolisthesis were offered enrollment in a randomized cohort or an observational cohort. Treatment was standard decompressive laminectomy (with or without fusion) or usual nonsurgical care. The primary outcome measures were the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36) bodily pain and physical function scores (100-point scales, with higher scores indicating less severe symptoms) and the modified Oswestry Disability Index (100-point scale, with lower scores indicating less severe symptoms) at 6 weeks, 3 months, 6 months, 1 year, and 2 years.ResultsWe enrolled 304 patients in the randomized cohort and 303 in the observational cohort. The baseline characteristics of the two cohorts were similar. The one-year crossover rates were high in the randomized cohort (approximately 40% in each direction) but moderate in the observational cohort (17% crossover to surgery and 3% crossover to nonsurgical care). The intention-to-treat analysis for the randomized cohort showed no statistically significant effects for the primary outcomes. The as-treated analysis for both cohorts combined showed a significant advantage for surgery at 3 months that increased at 1 year and diminished only slightly at 2 years. The treatment effects at 2 years were 18.1 for bodily pain (95% confidence interval [CI], 14.5 to 21.7), 18.3 for physical function (95% CI, 14.6 to 21.9), and -16.7 for the Oswestry Disability Index (95% CI, -19.5 to -13.9). There was little evidence of harm from either treatment.ConclusionsIn nonrandomized as-treated comparisons with careful control for potentially confounding baseline factors, patients with degenerative spondylolisthesis and spinal stenosis treated surgically showed substantially greater improvement in pain and function during a period of 2 years than patients treated nonsurgically. (ClinicalTrials.gov number, NCT00000409 [ClinicalTrials.gov].).

Dataset Information

Surgery versus nonsurgical treatment of lumbar spinal stenosis: a randomized trial.

Background

Objective

Design

Setting

Participants

Intervention

Measurements

Results

Limitation

Conclusion

Primary funding source

Publications

Surgery versus nonsurgical treatment of lumbar spinal stenosis: a randomized trial.

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