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

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.

Neuromuscular Electrical Stimulation Compared to Volitional Exercise for Improving Muscle Function in Rheumatoid Arthritis: A Randomized Pilot Study.

OBJECTIVE: The aim of this study was to compare the feasibility and effectiveness of neuromuscular electrical stimulation (NMES) with that of high-intensity volitional resistance training for improving muscle structure and function and physical function in patients with rheumatoid arthritis (RA). We also compared pre-intervention and post-intervention values of myocyte characteristics. METHODS: In this 2-group, single-blind, randomized pilot study, adult patients with RA were assigned to 36 sessions of NMES (n = 31 patients) or volitional training (n = 28 patients) over 16 weeks. Outcome measures included muscle structure and function (quadriceps muscle area, density, and strength), physical function (performance-based and patient-reported), feasibility (increased pain, increased disease activity, attrition, and adherence), and myocyte characteristics (area, proportion of type I or II muscle fibers, and intramyocellular lipid content). Analysis of covariance was used to compare groups. RESULTS: The intervention intensity in the NMES group was less than half that in the volitional exercise group (31% versus 77% of maximum effort). Both groups experienced significant improvements in muscle structure and function (P < 0.001 to 0.019). Improvements in muscle characteristics and physical function were not different between groups. Exercise did not result in serious adverse events or increases in pain and disease activity. Attrition was 29% in the NMES group and 7% in the volitional exercise group. CONCLUSION: Both NMES and high-intensity volitional resistance training can be used as effective approaches to improving muscle structure and function in patients with RA. NMES may be a viable alternative for improving muscle function in patients in whom high-intensity resistance exercise may not be tolerated or is contraindicated, but attrition must be considered when using this approach.