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

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Abstract

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.

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Funding

This research was funded by the National Institute for Health Research (NIHR Health Technology Assessment Programme—HTA 10.99.01). NIHR funded the study. It developed a commissioning brief but had no role in the study design, data acquisition, analysis, or manuscript preparation. The chief investigator (KLB) assumes overall responsibility for the data in the manuscript. All named investigators had full access to the trial dataset. The views expressed are those of the authors and are not an official view of the institutions or funders.

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Authors and Affiliations

  1. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), Botnar Research Centre, University of Oxford, Oxford, OX3 7LD, UK

    K.L. Barker, M.K. Javaid, D. Smith, V. Gandhi, C. Cooper & S.E. Lamb

  2. Physiotherapy Research Unit, Physiotherapy Department, Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Windmill Road, Oxford, OX3 7LD, UK

    K.L. Barker, M. Newman, C.M. Lowe & T. Hughes

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

    N. Stallard & A. Noufaily

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

    J. Leal

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  1. K.L. Barker
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on behalf of the PROVE trial group

Corresponding author

Correspondence to K.L. Barker.

Ethics declarations

The trial was approved by the UK South Central Research Ethics Committee (REC: 12/SC/0411) and site-specific approvals were obtained.

Competing interests

Karen Barker, Meredith Newman, Nigel Stallard, Jose Leal, Catherine Minns Lowe, Angela Noufaily, Tamsin Hughes, David Smith, Sarah Lamb, and Varsha Gandhi declare no competing interests.

Dr. Javaid reports personal fees from Optasia and personal fees from Zebra Medical Vision, outside the submitted work.

Professor Cooper reports personal fees from Alliance for Better Health, Amgen, Eli Lilly, GSK, Medtronic, Merck, Novartis, Pfizer, Roche, Servier, Takeda, and UCB.

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The lead author (KLB) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported.

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Barker, K., Newman, M., Stallard, N. et al. Physiotherapy rehabilitation for osteoporotic vertebral fracture—a randomised controlled trial and economic evaluation (PROVE trial). Osteoporos Int 31, 277–289 (2020). https://doi.org/10.1007/s00198-019-05133-0

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