The Clinical Effectiveness of a Physiotherapy Delivered Physical and Psychological Group Intervention for Older Adults With Neurogenic Claudication: The BOOST Randomized Controlled Trial
Esther Williamson, Graham Boniface, Ioana R. Marian, Susan Dutton, Angela Garrett, Alana Morris, Zara Hansen, Lesley Ward, Philippa Nicolson, David Rogers, Karen Barker, Jeremy Fairbank, Judith Fitch, David French, Christine Comer, Christian Mallen, Sarah E Lamb, Mandy Maredza, Stavros Petrou, Julie Bruce, Frances Griffith, Gary S. Collins, Charles Hutchinson, Richard Gagen, Mandy Slack, Oliver Conway, Judith Fitch, Eileen Turner, John Arden, David Torgerson, Catherine Sackley, Candy McCabe, Stephanie Taylor, Catherine Hewitt, Anne Förster, Lindsey Bearne, Jim Watson
Abstract
BACKGROUND: Neurogenic claudication (NC) is a debilitating spinal condition affecting older adults' mobility and quality of life. METHODS: A randomized controlled trial of 438 participants evaluated the effectiveness of a physical and psychological group intervention (BOOST program) 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 randomized 2:1 to the BOOST program or BPA. The primary outcome was the Oswestry Disability Index (ODI) at 12 months. Data were 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 (standard deviation [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, 1.17]), but, at 6 months, ODI scores favored the BOOST program (adjusted MD: -3.7 [95% CI -6.27, -1.06]). At 12 months, the BOOST program resulted in greater improvements in walking capacity (6MWT MD: 21.7m [95% CI 5.96, 37.38]) and ODI walking item (MD: -0.2 [95% CI -0.45, -0.01]) and reduced falls risk (odds ratio: 0.6 [95% CI 0.40, 0.98]) compared to BPA. No serious adverse events were related to either treatment. CONCLUSIONS: The BOOST program substantially improved mobility for older adults with NC. Future iterations of the program will consider ways to improve long-term pain-related disability. Clinical Trials Registration Number: ISRCTN12698674.