PROVE

Botnar

The NIHR Health Technology Assessment programme identified a need for a high quality research study to answer the question "Does a physiotherapy package improve clinical outcomes after osteoporotic vertebral fracture and is it cost-effective?" and funded the PROVE trial.

HTA Project Reference: 10/99/01

The Physiotherapy Rehabilitation for Osteoporotic Vertebral Fracture (PROVE) study is a clinical trial planning to compare usual care versus an exercise based intervention versus a manual therapy based intervention. It aims to recruit 600 patients from centres across the UK.

SITES

Background

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.

Objectives

To complete a definitive randomised controlled trial to assess the clinical outcomes of patients treated by two physiotherapy management strategies: manual therapy and exercise therapy, each compared to normal care
To assess the safety of and any side effects associated with the treatment programmes
To assess the acceptability and adherence to the physiotherapy programmes for patients and therapists through both the RCT and a nested qualitative study
To conduct a health economic analyses to assess the cost effectiveness of the different treatment strategies

Trial design

PROVE is a prospective, multi-centred adaptive randomised controlled trial with three arms and blinded outcome assessment. Measures at baseline (0 months), post intervention (16 weeks) 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. The trial aims to recruit 600 patients over three years from centres within the UK.

Outcome measures

Primary outcome: Quality of life measured by the QUALEFFO 41questionnaire.

Secondary outcome measures: Pain will be measured using a 10 point VAS; 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.