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The clinical effectiveness of a physiotherapy delivered physical and psychological group intervention for older adults with neurogenic claudication: the BOOST randomised controlled trial |
Williamson E, Boniface G, Marian IR, Dutton SJ, Garrett A, Morris A, Hansen Z, Ward L, Nicolson PJA, Rogers D, Barker KL, Fairbank J, Fitch J, French DP, Comer C, Mallen CD, Lamb SE, on behalf of the BOOST Research Group |
The Journals of Gerontology. Series A, Biological Sciences and Medical Sciences 2022 Aug;77(8):1654-1664 |
clinical trial |
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; 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* |
BACKGROUND: Neurogenic claudication (NC) is a debilitating spinal condition affecting older adults' mobility and quality of life. METHODS: A randomised controlled trial of 438 participants evaluated the effectiveness of a physical and psychological group intervention (BOOST programme) compared to physiotherapy assessment and tailored advice (best practice advice (BPA)) for older adults with NC. Participants were identified from spinal clinics (community and secondary care) and general practice records and randomised 2:1 to the BOOST programme or BPA. The primary outcome was the Oswestry Disability Index (ODI) at 12 months. Data was also collected at 6 months. Other outcomes included ODI walking item, 6-minute walk test (6MWT) and falls. The primary analysis was intention-to-treat. RESULTS: The average age of participants was 74.9 years (SD 6.0) and 57% (246/435) were female. There was no significant difference in ODI scores between treatment groups at 12 months (adjusted mean difference (MD) -1.4 (95% confidence Intervals (CI) -4.03 to 1.17)), but, at 6 months, ODI scores favoured the BOOST programme (adjusted MD -3.7 (95% CI -6.27 to -1.06)). At 12 months, the BOOST programme resulted in greater improvements in walking capacity (6MWT MD 21.7m (95% CI 5.96 to 37.38)) and ODI walking item (MD -0.2 (95% CI -0.45 to -0.01)) and reduced falls risk (odds ratio 0.6 (95% CI 0.40 to 0.98)) compared to BPA. No serious adverse events were related to either treatment. CONCLUSIONS: The BOOST programme substantially improved mobility for older adults with NC. Future iterations of the programme will consider ways to improve long-term pain related disability. CLINICAL TRIALS REGISTRATION NUMBER: ISRCTN12698674.
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