Physiotherapy Rehabilitation for Osteoporotic Vertebral fracture (PROVe)

Not Applicable

Completed

• Conditions: Osteoporosis; Musculoskeletal Diseases; Osteoporosis, unspecified

• Registration Number: ISRCTN49117867
• Lead Sponsor: Oxford University Hospitals NHS Trust (UK)

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31456562 (added 29/08/2019) 2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24422876

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-15
• Study Completion: 2018-03-31
• Last Update Posted: 16 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 615

Inclusion Criteria

1. Men and women
2. A diagnosis of primary osteoporosis confirmed by radiograph or by DEXA scan of <= -2.5 at lowest lumbar level
3. At least 1 painful vertebral fracture sustained previously.
4. At different times post vertebral fracture and with different numbers and sites of fractures
5. Female participants will need to be postmenopausal as defined by the date of their last period which should be more than 2 years previously.
6. All participants will have had appropriate fracture prevention therapy under NICE TA 161, be able to walk independently with or without an aid at least 10 metres and be able to participate in a physiotherapy programme.

Exclusion Criteria

1. Have any condition which might make participating in physiotherapy unsafe, including severe unstable cardiovascular or pulmonary disease, osteoporosis secondary to metabolic bone disorders or other disease and neurological disorders.
2. Those whose primary problem is back pain with radiating pain into the lower limb will be excluded as will individuals who have had vertebroplasty, facet joint injection or physical therapy e.g. chiropractic, osteopathy or physiotherapy treatment for back pain in the previous 12 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> QUALEFFO 41 Quality of Life questionnaire<br><br> Sub study- Inclinometer, tragus to wall, flexicurve measures for relaibility<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Timed load stand test<br> 2. Spinal posture<br> 3. Short performance physical battery<br> 4. Functional reach test, 6 minute walk, PASE questionnaire, EQ5D, pain VAS<br>