Physiotherapy Rehabilitation for Osteoporotic Vertebral Fracture - A randomised controlled trial and economic evaluation (PROVE trial): ISRCTN 49117867
Barker K., Newman M., Stallard N., Leal J., Lowe CM., Javaid M., Noufaily A., Adhikari A., Smith D., Gandhi V., Cooper C., Lamb S.
Physiotherapy Rehabilitation for Osteoporotic Vertebral Fracture - A randomised controlled trial and economic evaluation (PROVE trial): ISRCTN 49117867 Karen Barker*1, Meredith Newman2, Nigel Stallard3, Jose Leal1, Catherine Minns Lowe2, Muhammad Javaid1, Angela Noufaily3, Anish Adhikari 1, David Smith1, Varsha Gandhi1, Cyrus Cooper1, Sarah Lamb1. 1University of Oxford, United Kingdom, 2Oxford University Hospitals Foundation Trust, United Kingdom, 3University of Warwick, United Kingdom. Purpose: Vertebral fragility fractures are associated with significant pain an reduction in quality of life. Physical therapy is often recommended for patients and typically includes manual vs. exercise therapy. There is little evidence to support either approach. We investigated the clinical and cost-effectiveness of two different physiotherapy programmes for people with symptomatic osteoporotic vertebral fractures compared with a single session of physiotherapy. Methods: We performed a multicentre, assessor blinded, three-arm randomised trial of 7 sessions of manual therapy vs. exercise therapy delivered over 12 weeks compared to a single one hour session with a specialist physiotherapist in patients with symptomatic vertebral fractures. The co-primary outcomes were quality of life (QUALLEFO 41) and muscle endurance (Timed Loaded Standing (TLS) test) at 12 months. Secondary out-comes were: thoracic kyphosis measured with a Flexicurve ruler, balance evaluated via the Functional Reach (FR) test and physical function by the Short Performance Physical Battery (SPPB), 6 minute walk test and Physical Activity Scale for the Elderly (PACE), a health resource use diary and the EQ-5D-5L at 4 and 12 months. Results: 615 patients were enrolled with 216 patients randomised to the exercise therapy arm, 203 patients to manual therapy arm and 197 to usual care arm. The mean age was 72 .1 years and 87% were female. At 12 months, there were no significant benefits of either a course of exercise or manual therapy over a single hour session of physiotherapy. For the secondary outcomes, relative to a single session, there is significant improvement from exercise therapy at 4 months in the SPPB, the FR test and the six minute walk test and from manual therapy at four months in TLS and FR. The treatment differences for TLS were significant in those patients under 70 years old, but not older. Neither the manual or exercise physiotherapy interventions were cost-effective relative to a single physiotherapy session using the £20,000 per QALY threshold. Conclusions: In the largest trial assessing physiotherapy in patients with osteoporotic fragility fractures, benefits were seen at 4 months but neither intervention was superior to a single one-hour advice session with a specialist physiotherapist at 12 months. Future research should focus on improving adherence to therapy recommendations. Disclosures: Karen Barker, None