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Barker K1,2, Newman M1, Stallard N3, Leal J4, Minns Lowe C1, Javaid MK2, Noufaily A3, Hughes T1, Smith D2, Gandhi V2, Lamb S2
1Oxford University Hospitals NHS Foundation Trust, Physiotherapy Research Unit, Oxford, United Kingdom, 2University of Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, United Kingdom, 3University of Warwick, Division of Health Sciences, Warwick Medical School, Warwick, United Kingdom, 4University of Oxford, Health Economics Research Centre, Department Population Health, Oxford, United Kingdom
Background: 25,000 people in the UK have osteoporosis related vertebral fracture (OVF). There is increasing evidence that physiotherapy may have an important treatment role.
Purpose: To investigate the clinical and cost-effectiveness of two different physiotherapy programmes for people with osteoporosis and vertebral fracture, in comparison to a single session of physiotherapy.
Methods:
Design: Prospective, adaptive, multicentre, assessor blinded, RCT with nested qualitative and health economic studies.
Setting: 21 NHS Physiotherapy Departments
Participants: People with osteoporosis and a clinically diagnosed vertebral fracture
Interventions: 7 sessions of either manual therapy or exercise therapy out-patient physiotherapy delivered over 12 weeks compared to best practice of a single 1 hour session with a specialist physiotherapist.
Main outcome measures: Outcomes were measured at 4 and 12 months. The primary outcomes were quality of life and muscle endurance measured by the disease specific QUALLEFO 41 and Timed Loaded Standing (TLS) test respectively. Secondary outcomes were: thoracic kyphosis measured with a Flexicurve ruler, balance evaluated via the Functional Reach (FR) test and physical function assessed via the Short Performance Physical Battery (SPPB), 6 minute walk test (6MWT) and Physical Activity Scale for the Elderly (PASE), a health resource use and falls diary and the EQ-5D-5L.
Results: 615 participants, 531 (86.6%) female, were enrolled with 216, 203 and 196 randomised by computer generated programme to exercise therapy, manual therapy arm and usual care. Baseline data were available for 613 participants with mean age 72.14 (SD 9.09) years. Primary outcome data were obtained for 69% (429/615). Interim analysis met the criteria to continue all arms. For primary outcomes there were no significant benefits over usual care or exercise (difference and 95% ci: -0.23 (-3.20, 1.59), p = 1.000 for QUALEFFO 41, 5.77 (-4.85, 20.46), p = 0.437 for TLS) or manual therapy (difference and 95% ci: 1.35 (-1.76, 2.93), p = 0.744 for QUALEFFO 41, 9.69 (0.09, 24.86), p = 0.335 for TLS). At 4 months there were significant gains between usual care and both manual and exercise therapy in TLS in participants under 70 years old. There were significant improvements over usual care due to exercise therapy at four months in SPPB, FR and 6MWT and for manual therapy at four months in TLS and FR.
Neither manual nor exercise therapy was cost-effective relative to usual care a single physiotherapy session using the £20,000/QALY threshold. There were no treatment related serious adverse events.
Conclusion(s): This is the largest RCT assessing physiotherapy in participants with OVFs to date. At one year neither of the new interventions conferred more benefit than a single 1-hour advice session with a specialist physiotherapist.
Implications: Benefits were short lived, future work should focus on the intensity and duration of interventions to determine if changes to these would demonstrate more sustained effects of the interventions.
Keywords: osteoporosis, vertebral facture, physiotherapy
Funding acknowledgements: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme: HTA 10/99/01
Purpose: To investigate the clinical and cost-effectiveness of two different physiotherapy programmes for people with osteoporosis and vertebral fracture, in comparison to a single session of physiotherapy.
Methods:
Design: Prospective, adaptive, multicentre, assessor blinded, RCT with nested qualitative and health economic studies.
Setting: 21 NHS Physiotherapy Departments
Participants: People with osteoporosis and a clinically diagnosed vertebral fracture
Interventions: 7 sessions of either manual therapy or exercise therapy out-patient physiotherapy delivered over 12 weeks compared to best practice of a single 1 hour session with a specialist physiotherapist.
Main outcome measures: Outcomes were measured at 4 and 12 months. The primary outcomes were quality of life and muscle endurance measured by the disease specific QUALLEFO 41 and Timed Loaded Standing (TLS) test respectively. Secondary outcomes were: thoracic kyphosis measured with a Flexicurve ruler, balance evaluated via the Functional Reach (FR) test and physical function assessed via the Short Performance Physical Battery (SPPB), 6 minute walk test (6MWT) and Physical Activity Scale for the Elderly (PASE), a health resource use and falls diary and the EQ-5D-5L.
Results: 615 participants, 531 (86.6%) female, were enrolled with 216, 203 and 196 randomised by computer generated programme to exercise therapy, manual therapy arm and usual care. Baseline data were available for 613 participants with mean age 72.14 (SD 9.09) years. Primary outcome data were obtained for 69% (429/615). Interim analysis met the criteria to continue all arms. For primary outcomes there were no significant benefits over usual care or exercise (difference and 95% ci: -0.23 (-3.20, 1.59), p = 1.000 for QUALEFFO 41, 5.77 (-4.85, 20.46), p = 0.437 for TLS) or manual therapy (difference and 95% ci: 1.35 (-1.76, 2.93), p = 0.744 for QUALEFFO 41, 9.69 (0.09, 24.86), p = 0.335 for TLS). At 4 months there were significant gains between usual care and both manual and exercise therapy in TLS in participants under 70 years old. There were significant improvements over usual care due to exercise therapy at four months in SPPB, FR and 6MWT and for manual therapy at four months in TLS and FR.
Neither manual nor exercise therapy was cost-effective relative to usual care a single physiotherapy session using the £20,000/QALY threshold. There were no treatment related serious adverse events.
Conclusion(s): This is the largest RCT assessing physiotherapy in participants with OVFs to date. At one year neither of the new interventions conferred more benefit than a single 1-hour advice session with a specialist physiotherapist.
Implications: Benefits were short lived, future work should focus on the intensity and duration of interventions to determine if changes to these would demonstrate more sustained effects of the interventions.
Keywords: osteoporosis, vertebral facture, physiotherapy
Funding acknowledgements: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme: HTA 10/99/01
Topic: Musculoskeletal; Older people; Rheumatology
Ethics approval required: Yes
Institution: NHS Health Research Authority
Ethics committee: NRES South Central
Ethics number: 12/SC/0411
All authors, affiliations and abstracts have been published as submitted.
