A back pain checklist (Vfrac) for use in primary care to identify older women with back pain due to un-diagnosed broken bones in the back

Not Applicable

Completed

• Conditions: Osteoporotic vertebral fracture; Musculoskeletal Diseases; Osteoporosis

• Registration Number: ISRCTN16550671
• Lead Sponsor: niversity of Bristol

Brief Summary

2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/30684069/ protocol (added 25/03/2019) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35284926/ results (added 19/06/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-24
• Study Completion: 2020-10-01
• Last Update Posted: 4 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1635

Inclusion Criteria

1. Willing and able to give informed consent for participation in the study
2. Self-reported back pain in the previous 4 months
3. Aged over 65 years

Exclusion Criteria

Current exclusion criteria as of 23/01/2019:
1. Aged 65 years or under
2. No self-reported back pain reported in the previous 4 months
3. Has already had a full spinal x-ray in the previous 4 months that is not available to the research team
4. Considered unsuitable to take part by their GP (e.g. cognitive impairment or near end of life)

Previous exclusion criteria:
1. Aged 65 years or under
2. No self-reported back pain reported in the previous 4 months
3. Has already had a full spinal x-ray in the previous 4 months
4. Considered unsuitable to take part by their GP (e.g. cognitive impairment or near end of life)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure will be the accuracy of the Vfrac tool as estimated by the sensitivity and specificity. We are aiming for a sensitivity and specificity of greater than 80% to justify subsequent exploration in a definitive trial. The method of measurement will be self-reported questionnaire data at recruitment followed by data collection in research clinic plus spinal radiograph as soon as possible after recruitment.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Cost effectiveness of Vfrac based upon follow-up of women from the primary outcome cohort to identify if a future definitive cluster randomised controlled trial is appropriate<br> 2. Sources of variance that can be tested in a pilot as part of a future bid<br> 3. Stopping rules for a future trial. The output of this will be a decision on whether a future definitive trial is warranted.<br>