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Exercise or manual physiotherapy compared with a single session of physiotherapy for osteoporotic vertebral fracture : three-arm PROVE RCT
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Barker, Karen L., Newman, Meredith, Stallard, Nigel, Leal, Jose, Minns Lowe, Catherine, Javaid, Muhammad K., Noufaily, Angela, Adhikari, Anish, Hughes, Tamsin, Smith, David J., Gandhi, Varsha, Cooper, Cyrus and Lamb, Sallie E. (2019) Exercise or manual physiotherapy compared with a single session of physiotherapy for osteoporotic vertebral fracture : three-arm PROVE RCT. Health Technology Assessment, 23 (44). pp. 1-318. doi:10.3310/hta23440 ISSN 1366-5278.
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Official URL: http://dx.doi.org/10.3310/hta23440
Abstract
Background:
A total of 25,000 people in the UK have osteoporotic vertebral fracture (OVF). Evidence suggests that physiotherapy may have an important treatment role.
Objective:
The objective was to investigate the clinical effectiveness and cost-effectiveness of two different physiotherapy programmes for people with OVF compared with a single physiotherapy session.
Design:
This was a prospective, adaptive, multicentre, assessor-blinded randomised controlled trial (RCT) with nested qualitative and health economic studies.
Setting:
This trial was based in 21 NHS physiotherapy departments.
Participants:
The participants were people with symptomatic OVF.
Interventions
Seven sessions of either manual outpatient physiotherapy or exercise outpatient physiotherapy compared with the best practice of a 1-hour single session of physiotherapy (SSPT).
Main outcome measures:
Outcomes were measured at 4 and 12 months. The primary outcomes were quality of life and muscle endurance, which were measured by the disease-specific QUALEFFO-41 (Quality of Life Questionnaire of the European Foundation for Osteoporosis – 41 items) and timed loaded standing (TLS) test, respectively. Secondary outcomes were (1) thoracic kyphosis angle, (2) balance, evaluated via the functional reach test (FRT), and (3) physical function, assessed via the Short Physical Performance Battery (SPPB), 6-minute walk test (6MWT), Physical Activity Scale for the Elderly, a health resource use and falls diary, and the EuroQol-5 Dimensions, five-level version.
Results:
A total of 615 participants were enrolled, with 216, 203 and 196 randomised by a computer-generated program to exercise therapy, manual therapy and a SSPT, respectively. Baseline data were available for 613 participants, 531 (86.6%) of whom were women; the mean age of these participants was 72.14 years (standard deviation 9.09 years). Primary outcome data were obtained for 69% of participants (429/615) at 12 months: 175 in the exercise therapy arm, 181 in the manual therapy arm and 173 in the SSPT arm. Interim analysis met the criteria for all arms to remain in the study. For the primary outcomes at 12 months, there were no significant benefits over SSPT of exercise [QUALEFFO-41, difference –0.23 points, 95% confidence interval (CI) –3.20 to 1.59 points; p = 1.000; and TLS test, difference 5.77 seconds, 95% CI –4.85 to 20.46 seconds; p = 0.437] or of manual therapy (QUALEFFO-41, difference 1.35 points, 95% CI –1.76 to 2.93 points; p = 0.744; TLS test, difference 9.69 seconds (95% CI 0.09 to 24.86 seconds; p = 0.335). At 4 months, there were significant gains for both manual therapy and exercise therapy over SSPT in the TLS test in participants aged < 70 years. Exercise therapy was superior to a SSPT at 4 months in the SPPB, FRT and 6MWT and manual therapy was superior to a SSPT at 4 months in the TLS test and FRT. Neither manual therapy nor exercise therapy was cost-effective relative to a SSPT using the threshold of £20,000 per quality-adjusted life-year. There were no treatment-related serious adverse events.
Conclusions:
This is the largest RCT to date assessing physiotherapy in participants with OVFs. At 1 year, neither treatment intervention conferred more benefit than a single 1-hour physiotherapy advice session. The focus of future work should be on the intensity and duration of interventions to determine if changes to these would demonstrate more sustained effects.
Trial registration:
Current Controlled Trials ISRCTN49117867.
Funding:
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 44. See the NIHR Journals Library website for further project information.
Item Type: | Journal Article | ||||||
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Subjects: | R Medicine > RC Internal medicine | ||||||
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Statistics and Epidemiology Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Library of Congress Subject Headings (LCSH): | Osteoporosis, Osteoporosis -- Treatment, Orthopedics -- Cost effectiveness, Exercise therapy -- Evaluation, Physical therapy -- Evaluation, Clinical trials -- Cost effectiveness | ||||||
Journal or Publication Title: | Health Technology Assessment | ||||||
Publisher: | NIHR Health Technology Assessment programme | ||||||
ISSN: | 1366-5278 | ||||||
Official Date: | August 2019 | ||||||
Dates: |
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Volume: | 23 | ||||||
Number: | 44 | ||||||
Page Range: | pp. 1-318 | ||||||
DOI: | 10.3310/hta23440 | ||||||
Status: | Peer Reviewed | ||||||
Publication Status: | Published | ||||||
Reuse Statement (publisher, data, author rights): | © Queen’s Printer and Controller of HMSO 2019. This work was produced by Barker et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. | ||||||
Access rights to Published version: | Open Access (Creative Commons) | ||||||
Date of first compliant deposit: | 6 February 2020 | ||||||
Date of first compliant Open Access: | 6 February 2020 | ||||||
RIOXX Funder/Project Grant: |
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Contributors: |
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