K L Barker1,2, M Newman3, N Stallard4, J Leal5, C M Lowe3, M K Javaid6, A Noufaily4, T Hughes3, D Smith6, V Gandhi6, C Cooper6, S E Lamb6. 1. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), Botnar Research Centre, University of Oxford, Oxford, OX3 7LD, UK. karen.barker@ouh.nhs.uk. 2. Physiotherapy Research Unit, Physiotherapy Department, Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Windmill Road, Oxford, OX3 7LD, UK. karen.barker@ouh.nhs.uk. 3. Physiotherapy Research Unit, Physiotherapy Department, Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Windmill Road, Oxford, OX3 7LD, UK. 4. Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK. 5. Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK. 6. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), Botnar Research Centre, University of Oxford, Oxford, OX3 7LD, UK.
Abstract
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.
RCT Entities:
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.
Authors: Teresa Y L Liu-Ambrose; Karim M Khan; Janice J Eng; Stephen R Lord; Brian Lentle; Heather A McKay Journal: Osteoporos Int Date: 2005-02-09 Impact factor: 4.507
Authors: A Svedbom; F Borgstöm; E Hernlund; O Ström; V Alekna; M L Bianchi; P Clark; M D Curiel; H P Dimai; M Jürisson; R Kallikorm; M Lember; O Lesnyak; E McCloskey; K M Sanders; S Silverman; A Solodovnikov; M Tamulaitiene; T Thomas; N Toroptsova; A Uusküla; A N A Tosteson; B Jönsson; J A Kanis Journal: Osteoporos Int Date: 2017-12-11 Impact factor: 4.507
Authors: W B Katzman; E Vittinghoff; F Lin; A Schafer; R K Long; S Wong; A Gladin; B Fan; B Allaire; D M Kado; N E Lane Journal: Osteoporos Int Date: 2017-07-08 Impact factor: 4.507
Authors: D L Kendler; D C Bauer; K S Davison; L Dian; D A Hanley; S T Harris; M R McClung; P D Miller; J T Schousboe; C K Yuen; E M Lewiecki Journal: Am J Med Date: 2015-10-30 Impact factor: 4.965
Authors: D Pinto; M Alshahrani; R Chapurlat; T Chevalley; E Dennison; B M Camargos; A Papaioannou; S Silverman; J-F Kaux; N E Lane; J Morales Torres; J Paccou; R Rizzoli; O Bruyere Journal: Osteoporos Int Date: 2022-01-20 Impact factor: 4.507