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| Comparative clinical effectiveness of nonsurgical treatment methods in patients with lumbar spinal stenosis: a randomized clinical trial [with consumer summary] |
| Schneider MJ, Ammendolia C, Murphy DR, Glick RM, Hile E, Tudorascu DL, Morton SC, Smith C, Patterson CG, Piva SR |
| JAMA Network Open 2019 Jan;2(1):e186828 |
| clinical trial |
| 6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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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 to 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.
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