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Supervised physical therapy versus unsupervised exercise for patients with lumbar spinal stenosis: 1-year follow-up of a randomized controlled trial [with consumer summary] |
Minetama M, Kawakami M, Teraguchi M, Kagotani R, Mera Y, Sumiya T, Nakagawa M, Yamamoto Y, Matsuo S, Sakon N, Nakatani T, Kitano T, Nakagawa Y |
Clinical Rehabilitation 2021 Jul;35(7):964-975 |
clinical trial |
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; 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* |
OBJECTIVE: To compare the 1-year outcomes of patients with lumbar spinal stenosis treated with supervised physical therapy or unsupervised exercise. DESIGN: A single-center randomized controlled trial with concealed allocation, blinded assessor and intention-to-treat analysis. SETTING: Spine care center. SUBJECTS: A total of 86 patients presenting with symptoms of neurogenic claudication caused by lumbar spinal stenosis. INTERVENTIONS: The physical therapy group received supervised physical therapy sessions twice a week for 6 weeks and home exercise program. The home exercise group received 6-week home exercise program only. MAIN MEASURES: The primary outcome was symptom severity on the Zurich claudication questionnaire at 1 year. Secondary outcomes included physical function, pain, health-related quality of life and the surgery rate after 1 year. RESULTS: At 1 year, more patients in the physical therapy group than in the home exercise group achieved minimum clinically important differences in Zurich claudication questionnaire symptom severity (60.5% versus 32.6%; adjusted odds ratio (AOR) 4.3 (95% CI 1.5 to 12.3), p = 0.01); Zurich claudication questionnaire physical function (55.8% versus 32.6%; AOR 3.0 (1.1 to 8.1), p = 0.03); SF-36 bodily pain (48.8% versus 25.6%; AOR 2.8 (1.1 to 7.3), p = 0.03), and SF-36 general health (20.9% versus 7.0%; AOR 6.1 (1.1 to 33.0), p = 0.04). The surgery rate at 1 year was lower in the physical therapy than in the home exercise group (7.0% versus 23.3%; AOR 0.2 (0.04 to 0.9) p = 0.04). CONCLUSIONS: Supervised physical therapy produced greater improvements in symptom severity and physical function than unsupervised exercise and was associated with lower likelihood of receiving surgery within 1 year.
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