Physiotherapy rehabilitation for osteoporotic vertebral fracture—a randomised controlled trial and economic evaluation (PROVE trial)

Abstract

To evaluate the clinical and cost-effectiveness of different physiotherapy approaches for people with osteoporotic vertebral fracture(s) (OVF). >Prospective, multicentre, adaptive, three-arm randomised controlled trial. Six hundred fifteen adults with back pain, osteoporosis, and at least 1 OVF participated. 7 individual physiotherapy sessions over 12weeks focused on either manual therapy or home exercise compared with a single session of physiotherapy education (SSPT). The co-primary outcomes were quality of life and back muscle endurance measured by the QUALEFFO-41 and timed loaded standing (TLS) test at 12months. At 12months, there were no statistically significant differences between groups. Mean QUALEFFO-41: -1.3 (exercise), -0.15 (manual), and -1.2 (SSPT), a mean difference of -0.2 (95% CI, -3.2 to 1.6) for exercise and 1.3 (95% CI, -1.8 to 2.9) for manual therapy. Mean TLS: 9.8s (exercise), 13.6s (manual), and 4.2s (SSPT), a mean increase of 5.8s (95% CI, -4.8 to 20.5) for exercise and 9.7s (95% CI, 0.1 to 24.9) for manual therapy. Exercise provided more quality-adjusted life years than SSPT but was more expensive. At 4months, significant changes above SSPT occurred in endurance and balance in manual therapy, and in endurance for those ≤70years, in balance, mobility, and walking in exercise. Adherence was problematic. Benefits at 4months did not persist and at 12months, we found no significant differences between treatments. There is inadequate evidence a short physiotherapy intervention of either manual therapy or home exercise provides long-term benefits, but arguably short-term benefits are valuable. ISRCTN 49117867.