PROVE: Physiotherapy Rehabilitation for Osteoporotic Vertebral Fracture

Each year in the UK, 25,000 people suffer from vertebral (spine) fractures related to their osteoporosis. Research evidence exists to suggest that physiotherapy may help to ease pain, aid recovery, and help patients get back to their normal activities of daily life as soon as possible. There is uncertainty however as to which type of physiotherapy (manual, exercise etc.) is most helpful to people, how much the treatment costs the NHS, and what patient’s think of their treatment. This RCT will randomise patients with osteoporotic vertebral fracture to one of three trial arms: manual physiotherapy (e.g. massage and back manipulation), exercise physiotherapy (e.g. stretches, walking and balance exercises) or standard practice with no physiotherapy. The primary outcome for the trial is quality of life, as measured using the QUALEFFO41 questionnaire. The trial will follow patients until 12 months, however an interim analysis is planned for 3 months, and if one treatment is shown to be clearly superior at this point, the trial will be adapted to a two arm design.

A cost-effectiveness analysis is planned as an integral part of the trial. Conducted from an NHS perspective, data will be collected on resources required to implement the trial interventions, and on patients’ primary and secondary care NHS contacts out to 12 months. Patients will also be asked about any unpaid informal care they have received and any costs they themselves had had to incur.  Patients will complete the EuroQol EQ-5D at baseline, 3, 6, and 12 months, and responses combined with survival data to generate Quality Adjusted Life Years (QALYs).  Cost-effectiveness will be computed and supplementary analyses will utilise data from the trial as well as from other sources to extrapolate costs, QALYs and cost-effectiveness beyond the 12-month trial follow-up.