Trial Summary

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).


  1. 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
  2. To assess the safety of and any side effects associated with the treatment programmes
  3. To assess the acceptability and adherence to the physiotherapy programmes for patients and therapists through both the RCT and a nested qualitative study
  4. 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.

Inclusion Criteria

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.

Exclusion Criteria

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.

Trial interventions

On randomisation, patients will be allocated to one of 3 possible arms

  1. Will receive a single education session and attention control by scheduled telephone calls.
  2. Manual therapies will include low velocity spinal mobilisations, soft tissue massage, postural taping and a passive extension stretch.
  3. Exercise therapies will include a programme of active stretches, walking, balance activities and strength training involving lumbar stabilisation,trunk extension, upper and lower limb exercises.

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.

Follow up

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.