Dynamic change and influence of osteoporotic back pain with vertebral fracture on related activities and social participation: evaluating reliability and validity of a newly developed outcome measure.

The objective of this study was to record the clinical course of osteoporosis over time in Japanese women. We hypothesized that successful control of acute pain associated with osteoporosis will allow better treatment for health-related problems. To confirm this working hypothesis, we developed the Japan Questionnaire for Osteoporotic Pain (JQ22) to measure health status associated with osteoporosis. We examined the validity and reliability of the JQ22 compared with the current gold standard scale for back pain, the Roland Morris questionnaire (RDQ). A total of 125 women who were more than 65 years old, had an acute back pain episode, and had a fragile vertebral fracture confirmed by X-ray and clinical signs, participated in this study. The psychometric analyses for validity and reliability were tested for the JQ22 and the RDQ. The time course up to 6 weeks was observed by investigating both changes in pain characteristics and its influence on related activities and social participation. Cronbach's alpha coefficient was 0.979 and 0.919 for the JQ22 and RDQ, respectively. The Akaike Information Criterion (AIC) indicated that the JQ22 items were separated into four domains, which were sequentially arranged at the baseline and subsequently changed. This structure reflected osteoporotic back characteristics covering a range from pain to social activities. The JQ22 was shown to be a valid and reliable scale for patient-based measurement of osteoporotic back pain. It also revealed both changes in pain characteristics and the influence of pain on related activities and participation.