Format

Send to

Choose Destination
Health Technol Assess. 2019 Aug;23(44):1-318. doi: 10.3310/hta23440.

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

Author information

1
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
2
Physiotherapy Research Unit, Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
3
Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.
4
Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.

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.

plain-language-summary:

Osteoporosis is a condition in which bones lose their strength and are more likely to break. It affects around 3 million people in the UK. Fractures of the spine are very common in people with osteoporosis. They can cause a change in body shape, back pain and difficulty with carrying out daily tasks. A treatment that may help people is physiotherapy. There is evidence that several different types of physiotherapy, such as exercise or manual (hands-on) therapy, may help. This was the largest trial of physiotherapy for people with osteoporotic vertebral fracture to date. Seven sessions of physiotherapy treatment based on either exercise or manual therapy were compared with a single 1-hour session of individualised advice from a physiotherapist. The outcome of these treatments was assessed using recognised measures of quality of life, back muscle strength, pain, function and activity at 4 months and 1 year after treatment. How safe the treatments were and whether or not they had any impact on falls or the costs of health and social care were also examined. Interviews were conducted with some of the participants in the trial to seek their opinion about the treatment that they had received. The results show that the participants tolerated all the treatments well, with no significant safety issues, and perceived treatment to be beneficial. The study did not find significant differences between the three treatments in terms of clinical effectiveness or cost-effectiveness at 1 year, although there were benefits in some areas at 4 months.

KEYWORDS:

COST–BENEFIT ANALYSIS; EXERCISE THERAPY; KYPHOSIS; OSTEOPOROSIS; OSTEOPOROTIC FRACTURES; PHYSICAL THERAPY; PHYSICAL THERAPY MODALITIES; PHYSIOTHERAPY; REHABILITATION; VERTEBRAL FRACTURE

PMID:
31456562
PMCID:
PMC6732718
DOI:
10.3310/hta23440
Free full text

Conflict of interest statement

Sarah E Lamb reports grants from the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme during the conduct of the study and was a member of the following boards: HTA Additional Capacity Funding Board (2012–15), HTA Clinical Trials Board (2010–15), HTA End of Life Care and Add on Studies (2015), HTA Funding Boards Policy Group (previously Commissioning Strategy Group) (2010–15), HTA Maternal, Neonatal and Child Health Methods Group (2013–15), HTA Post-board funding teleconference (Prioritisation Group members to attend) (2010–15), HTA Primary Care Themed Call board (2013–14), HTA Prioritisation Group (2010–15) and NIHR Clinical Trials Unit Standing Advisory Committee (2012–16). Muhammad K Javaid reports personal fees from Optasia Medical Ltd (Cheadle, UK) and Zebra Medical Vision, Inc. (Shefayim, Israel) outside the submitted work. Cyrus Cooper reports personal fees from Alliance for Better Health (Troy, NY, USA), Amgen Inc. (Thousand Oaks, CA, USA), Eli Lilly and Company (Indianapolis, IN, USA), GlaxoSmithKline plc (Middlesex, UK), Medtronic (Watford, UK), Merck & Co. Inc. (Kenilworth, NJ, USA), Novartis Pharmaceuticals UK Ltd (Frimley, UK), Pfizer Inc. (New York, NY, USA), F. Hoffman-La Roche Ltd (Basel, Switzerland), Servier Laboratories Limited (Stoke Poges, UK), Takeda UK Ltd (Wooburn Green, UK) and UCB Pharma (Brussels, Belgium).

Supplemental Content

Full text links

Icon for National Institute for Health Research Journals Library Icon for NCBI Bookshelf
Loading ...
Support Center