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

• Published in: Osteoporosis international Vol. 31; no. 2; pp. 277 - 289
• Main Authors: Barker, K.L., Newman, M., Stallard, N., Leal, J., Lowe, C.M., Javaid, M.K., Noufaily, A., Hughes, T., Smith, D., Gandhi, V., Cooper, C., Lamb, S.E.
• Format: Journal Article
• Language: English
• Published: London Springer London 01.02.2020; Springer Nature B.V
• Subjects: Aged; Aged, 80 and over; Balance; Cost-Benefit Analysis; Endocrinology; Exercise Therapy - economics; Female; Humans; Male; Manipulative therapy; Medicine; Medicine & Public Health; Middle Aged; Original Article; Orthopedics; Osteoporosis; Osteoporosis - complications; Physical therapy; Physical Therapy Modalities - economics; Prospective Studies; Quality of Life; Rehabilitation; Rheumatology; Spinal Fractures - economics; Spinal Fractures - therapy; Statistical analysis; Vertebrae; Walking; Spinal fracture; Osteoporosis; Manual therapy; Rehabilitation; Physical therapy; Exercise therapy
• ISSN: 0937-941X; 1433-2965
• DOI: 10.1007/s00198-019-05133-0

Summary The trial compared three physiotherapy approaches: manual or exercise therapy compared with a single session of physiotherapy education (SSPT) for people with osteoporotic vertebral fracture(s). At 1 year, there were no statistically significant differences between the groups meaning there is inadequate evidence to support manual or exercise therapy. Introduction To evaluate the clinical and cost-effectiveness of different physiotherapy approaches for people with osteoporotic vertebral fracture(s) (OVF). Methods >Prospective, multicentre, adaptive, three-arm randomised controlled trial. Six hundred fifteen adults with back pain, osteoporosis, and at least 1 OVF participated. Interventions: 7 individual physiotherapy sessions over 12 weeks 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 12 months. Results At 12 months, 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: 9.8 s (exercise), 13.6 s (manual), and 4.2 s (SSPT), a mean increase of 5.8 s (95% CI, − 4.8 to 20.5) for exercise and 9.7 s (95% CI, 0.1 to 24.9) for manual therapy. Exercise provided more quality-adjusted life years than SSPT but was more expensive. At 4 months, significant changes above SSPT occurred in endurance and balance in manual therapy, and in endurance for those ≤ 70 years, in balance, mobility, and walking in exercise. Conclusions Adherence was problematic. Benefits at 4 months did not persist and at 12 months, 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. Trial registration ISRCTN 49117867.