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Effectiveness of physical therapy combined with epidural steroid injection for patients with lumbar spinal stenosis: a randomized parallel-group trial |
Hammerich A, Whitman J, Mintkin P, Denninger T, Akuthota V, Sawyer EE, Hofmann M, Childs JD, Cleland J |
Archives of Physical Medicine and Rehabilitation 2019 May;100(5):797-810 |
clinical trial |
6/10 [Eligibility criteria: No; 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* |
OBJECTIVE: To examine the effectiveness of epidural steroid injection (ESI) and back education with and without physical therapy (PT) in patients with lumbar spinal stenosis (LSS). DESIGN: Randomized clinical trial. SETTING: Orthopaedic spine clinics. PARTICIPANTS: 390 patients were screened with 60 eligible and randomly selected to receive ESI and education with or without PT. INTERVENTIONS: 54 patients received 1 to 3 injections and education in a 10 week intervention period with 31 receiving injections and education only (ESI) and 23 additionally receiving 8 to 10 sessions of multi-modal PT (ESI+PT). MAIN OUTCOME MEASURES: Disability, pain, quality of life, and global rating of change were collected at 10 weeks, 6 months, and 1 year and analyzed using linear mixed model analysis. RESULTS: No significant difference was found between ESI and ESI+PT in the Oswestry Disability Index at any time point although the sample had significant improvements at 10 weeks (p < 0.001; 95% CI -18.01 to -5.51) and 1 year (p = 0.01; 95% CI -14.57 to -2.03) above MCID. Significant differences in SF36 were found for ESI+PT at 10 weeks with higher emotional role function (p = 0.03; 95% CI -49.05 to -8.01), emotional well-being (p = 0.02; 95% CI -19.52 to 2.99), and general health perception (p = 0.05; 95% CI -17.20 to -.78). CONCLUSIONS: ESI+PT was not superior to ESI alone for reducing disability in people with LSS. Significant benefit was found for the addition of PT related to quality of life factors of emotional function, emotional well-being, and perception of general health.
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