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Exercise or manual physiotherapy compared with a single session of physiotherapy for osteoporotic vertebral fracture: three-arm PROVE RCT

Exercise or manual physiotherapy compared with a single session of physiotherapy for osteoporotic vertebral fracture: three-arm PROVE RCT
Exercise or manual physiotherapy compared with a single session of physiotherapy for osteoporotic vertebral fracture: three-arm PROVE RCT

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.

Aged, Cost-Benefit Analysis/economics, Exercise Therapy, Female, Humans, Male, Osteoporotic Fractures/therapy, Physical Therapy Modalities, Quality of Life/psychology, Spinal Fractures/therapy, Surveys and Questionnaires, Technology Assessment, Biomedical, United Kingdom
1366-5278
Barker, Karen L.
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Newman, Meredith
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Stallard, Nigel
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Leal, Jose
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Minns Lowe, Catherine
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Javaid, Muhammad K.
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Noufaily, Angela
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Adhikari, Anish
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Hughes, Tamsin
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Smith, David J.
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Gandhi, Varsha
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Cooper, Cyrus
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Lamb, Sarah E.
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Barker, Karen L.
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Newman, Meredith
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Stallard, Nigel
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Leal, Jose
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Minns Lowe, Catherine
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Javaid, Muhammad K.
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Noufaily, Angela
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Adhikari, Anish
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Hughes, Tamsin
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Smith, David J.
9ebe6cfe-d1c7-46eb-bc1d-11a5ff49243e
Gandhi, Varsha
56ea1011-9986-4ce1-8c65-83c63e033572
Cooper, Cyrus
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Lamb, Sarah E.
10720635-b8c7-4450-9f1f-22509fed6db8

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, Sarah 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). (doi:10.3310/hta23440).

Record type: Article

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.

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Published date: August 2019
Keywords: Aged, Cost-Benefit Analysis/economics, Exercise Therapy, Female, Humans, Male, Osteoporotic Fractures/therapy, Physical Therapy Modalities, Quality of Life/psychology, Spinal Fractures/therapy, Surveys and Questionnaires, Technology Assessment, Biomedical, United Kingdom

Identifiers

Local EPrints ID: 488733
URI: http://eprints.soton.ac.uk/id/eprint/488733
ISSN: 1366-5278
PURE UUID: 843a062f-84a5-4b3c-a878-30bc6da10466
ORCID for Cyrus Cooper: ORCID iD orcid.org/0000-0003-3510-0709

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Date deposited: 04 Apr 2024 17:13
Last modified: 13 Apr 2024 01:35

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Contributors

Author: Karen L. Barker
Author: Meredith Newman
Author: Nigel Stallard
Author: Jose Leal
Author: Catherine Minns Lowe
Author: Muhammad K. Javaid
Author: Angela Noufaily
Author: Anish Adhikari
Author: Tamsin Hughes
Author: David J. Smith
Author: Varsha Gandhi
Author: Cyrus Cooper ORCID iD
Author: Sarah E. Lamb

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