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

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.

Affiliations

¹Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), Botnar Research Centre, University of Oxford, Oxford, UK

²Physiotherapy Research Unit, Physiotherapy Department, Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK

³Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK

⁴Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK

Abstract and keywords

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.

Keywords: Exercise therapy; Manual therapy; Osteoporosis; Physical therapy; Rehabilitation; Spinal fracture

Links

DOI: 10.1007/s00198-019-05133-0

PubMed: 31720722

WoS: 000495937900001

History

Received: 2019-06-03

Accepted: 2019-08-14

Online: 2019-11-12

Cited Works (4)

Year	Entry
2017	Compston J, Cooper A, Cooper C, Gittoes N, Gregson C, Harvey N, Hope S, Kanis JA, McCloskey EV, Poole KES, Reid DM, Selby P, Thompson F, Thurston A, Vine N; The National Osteoporosis Guideline Group (NOGG). UK clinical guideline for the prevention and treatment of osteoporosis. Arch Osteoporos. December 2017;12(1):1-24.
2019	Kanis JA, Cooper C, Rizzoli R, Reginster J-Y; Scientific Advisory Board of the European Society for Clinical and Economic Aspects of Osteoporosis (ESCEO); Committees of Scientific Advisors and National Societies of the International Osteoporosis Foundation (IOF). European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporos Int. January 2019;30(1):3-44.
2017	Ballane G, Cauley JA, Luckey MM, Fuleihan GE-H. Worldwide prevalence and incidence of osteoporotic vertebral fractures. Osteoporos Int. May 2017;28(5):1531-1542.
2013	Svedbom A, Hernlund E, Ivergård M, Compston J, Cooper C, Stenmark J, McCloskey EV, Jönsson B, Kanis JA; EU review panel of the IOF. Osteoporosis in the European Union: a compendium of country-specific reports. Arch Osteoporos. December 2013;8(1):137.

Cited By (1)

Year	Entry
2022	Ponzano M. Risk Assessment and Interventions for Individuals At Risk of Osteoporotic Fractures [PhD thesis]. University of Waterloo; 2022.