Comparative Clinical Effectiveness of Nonsurgical Treatment Methods in Patients With Lumbar Spinal Stenosis: A Randomized Clinical Trial

Abstract

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.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Schneider reported grants from Patient-Centered Outcomes Research Institute (PCORI) during the conduct of the study. Dr Ammendolia reported grants from PCORI and Canadian Chiropractic Research Foundation during the conduct of the study and other support from Spinemobility outside the submitted work. Dr Murphy reported personal fees from CRISP Education and Research LLC and other support from Spine Care Partners outside the submitted work. Dr Hile reported grants from PCORI during the conduct of the study; grants from Presbyterian Health Foundation, Komen Central & Western Oklahoma, and Rehabilitation Nursing Foundation outside the submitted work; personal fees from Academy of Nutrition and Dietetics outside the submitted work; and had a patent to portable device for measuring toe strength and a patent to HI-FiVVE: bolus-dosed prehabilitation for cancer survivors. Dr Tudorascu reported grants from PCORI during the conduct of the study. Dr Patterson reported grants from PCORI during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.. Enrollment of Participants and Study Flow

aPrimary analysis was comparison of outcome measures from baseline to 2 months. To follow the intention-to-treat principle as closely as possible, data from all participants who were randomized (including dropouts with baseline data but missing follow-up data) were included in the analysis using linear mixed models.

Figure 2.. Responder Analyses (≥30% Improvement From Baseline) by Group and Time

Logistic regression models were used to compare the between-group proportions, controlling for baseline SSS, SPWT, and age. Only the 4 significant 2-way contrasts at 2 months are depicted by the gray lines and P values. All other contrasts at 2 months and 6 months were not significant. SenseWear indicates physical activity; SPWT, self-paced walking test; SSS, Swiss Spinal Stenosis questionnaire.