An observational cohort study to produce and evaluate an improved tool to screen older women with back pain for osteoporotic vertebral fractures (Vfrac): study protocol

Purpose: People with osteoporotic vertebral fractures are important to identify as they are at relatively high risk of further fractures. Despite this, less than a third of people with osteoporotic vertebral fractures come to clinical attention, due to various reasons including lack of clear triggers to identify who should have diagnostic spinal radiographs. This study aims to produce and evaluate a novel screening tool (Vfrac) for use in older women presenting with back pain in primary care, based on clinical triggers and predictors identified previously. This tool will generate a binary output to determine if a radiograph is required.

Methods: The Vfrac study is a two-site, pragmatic, observational cohort study recruiting 1633 women aged over 65 years with self-reported back pain. Participants will be recruited from primary care in two sites. The Vfrac study will use data from two self-completed questionnaires, a simple physical examination, a lateral thoracolumbar radiograph and information contained in medical records.

Results: The primary objective is to develop an easy to use clinical screening tool for identifying older women who are likely to have vertebral fractures.

Conclusions: This article describes the protocol of the Vfrac study; ISRCTN16550671.