Title: Physiotherapy Rehabilitation for Osteoporotic VErtebral fracture trial (PROVE)
Funder: Department of Health and Social Care

Abstract: Uncertainty exists regarding the best physiotherapeutic interventions to use with patients with vertebral osteoporotic fracture. Design: a prospective, multi-centred adaptive randomised controlled trial with three arms and blinded outcome assessment. Measures at baseline (0 months), post intervention (week 12) and 12 months. Participants will be randomised to control (A), manual (B) or exercise (C) interventions. An interim analysis at 3 months will be completed and if one intervention is clearly ineffective the trial will then be adapted to a two arm trial. A qualitative study using an interpretative phenomenological analysis (IPA) approach will be incorporated to explore experiences and views regarding the interventions. The trial will be preceded by an intervention development phase that includes a systematic review and pilot study. Settings: 10 centres Measurement of costs and outcomes: We will confirm diagnosis of osteoporosis and fracture through either radiographs, MRI or DXA. The primary outcome will be quality of life (QoL) as measured by the disease specific QUALEFFO 41 questionnaire. Pain will be measured using a 10 point VAS and the EQ5D will be used to evaluate health economics. We will measure kyphosis using a flexicurve ruler, strength with the Timed Loaded Standing (TLS) test, balance (proprioception) with the Short Physical Performance Battery (SPPB) and Functional Reach Tests (FRT), functional mobility and activity with the SPPB, a 6 minute walk and the Physical Activity Scale for the Elderly (PASE) questionnaire. Sample size: The initial sample size calculation is based on a traditional approach to a 3 arm trial. We wish to detect a standardised effect of 0.4 in the QUALEFFO; at 80% power and an alpha of 0.05 we would require 600 patients to be recruited

Lay abstract: Introduction: 25,000 people in the UK have vertebral (spine) fractures related to their osteoporosis each year and many of these are referred for physiotherapy to help them recover after their fracture/s. Physiotherapy includes a variety of treatment options, such as exercise programmes or ‘hands on’ treatments like massage and mobilisations. At the moment there is some research evidence which suggests that physiotherapy may help to ease pain and help patients get back to their normal activities of daily life as soon as possible. However, we do not know which type of physiotherapy is most helpful to people, how much this treatment is costing the NHS, or what patients’ think of their treatment. The research question: Which type of physiotherapy helps patients with osteoporosis recover most after vertebral fracture? The study will test exercise and manual treatments and compare patients who have had these treatments to patients who have usual care with no physiotherapy treatment. The research will also provide information about treatment costs, safety and about what patients think about their treatment. How the research will take place: Men and women with vertebral osteoporosis meeting the entry criteria for the study and who would like to take part will be asked to attend for three assessments, the first before any treatment happens, the second 12 weeks later and the third twelve months after the study starts. After the first assessment a computer programme will decide which study group the person will join: no physiotherapy treatment as usual, manual physiotherapy or exercise physiotherapy groups. The computer uses a randomisation process, using chance and similar to the toss of a coin, to place people in different groups. Every participant will continue taking any osteoporosis medication according to NICE guidelines, and will be offered education about osteoporosis and support through the trial with telephone calls every 2 months. In addition, the treatment groups will be offered 6 sessions of physiotherapy and asked to carry out some activities and exercises at home. The manual treatments used will include massage and back mobilisation, the exercise treatments will include strengthening of back and leg muscles, stretches, walking and balance exercises. The study includes a planned early assessment of the response to these treatments. If this early assessment indicates that one type of treatment is much better than the other then we will adapt our study, using a process called "adaptive design" so that we may then only have two study groups: no physiotherapy treatment as usual versus the best performing physiotherapy treatment group. People who join the study from this point on will join either of these two groups. If no physiotherapy group is superior at this stage we will continue with the original three groups until the study ends. Where the research will take place: Ten physiotherapy clinics in general practices and hospital outpatient departments, across the South Central region; this mix of settings will make the results more representative for the UK and also help to recruit the number of patients we need to answer the research question. The outcomes for the study: The main measure is a questionnaire asking about how much osteoporosis and back pain affects people’s lives. A further questionnaire will find out about everyday activity and exercise levels. A physical examination will assess peoples’ posture, balance, strength, walking and endurance. We will also give people a study diary and ask them to note any healthcare they use such as visits to their GP or practice nurse, any medication or other exercises. We will give people a calendar and ask them to note down if they have any falls or further fractures each month. A small number of people will be asked to talk about their experiences of the treatments to help us explore their experiences and views regarding treatment in greater depth. The ethical issues involved in this study: This study tests treatments already widely used within the NHS and will provide further information regarding safety. No new treatments are involved. All patient recruitment and data protection procedures will follow existing (previously approved) procedures and will be approved by the Research Ethics Committee before the study starts. Patients’ travel expenses will be reimbursed. The research team brings together a wealth of proven clinical, academic and research expertise. Importantly, a National Osteoporosis Society and Age UK representative will provide a lay perspective throughout.

Research activity codes: 6.7 PHYSICAL
Health categories: MUSCULOSKELETAL