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? (HTA 10/99).
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.
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.
Diagnosis of primary osteoporosis confirmed by radiograph or by DEXA scan of SD; -2.5 at lowest lumbar level.
At least 1 painful vertebral fracture sustained previously defined as patient reported back pain that has lasted for 24 hours or longer during the previous 12 months
Female participants will need to be postmenopausal as defined by the date of their last period which should be more than 2 years previously.
All participants will have had appropriate fracture prevention therapy under NICE TA 161
Able to walk independently with or without an aid for at least 10 metres
Able to participate in a physiotherapy programme.
Severe unstable cardiovascular or pulmonary disease
Back pain with radiating pain into the lower limb
Previous vertebroplasty, facet joint injection or physical therapy e.g.; chiropractic, osteopathy or physiotherapy treatment for back pain in the previous 12 weeks.
On randomisation, patients will be allocated to one of 3 possible arms
Groups B & C will be offered 7 physiotherapy sessions over 12 weeks and a home programme.
All groups will receive osteoporosis medication according to NICE TA161 and education about osteoporosis in line with information provided by the National Osteoporosis Society.
The patient will remain in the trial for 52 weeks post randomisation. Assessment visits will be held at week 0, 16 and 52.
The trial is funded by the National Institute for Health Research and is sponsored by the University of Oxford. The trial is based within the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science (NDORMS) at the University of Oxford. Study data is managed by the Clinical Trials Unit at the University of Warwick.