Fibromyalgia (FM) is a chronic widespread pain condition accompanied by fatigue, sleep disturbance, mood disorders, and impaired quality of life. Traditional Chinese Medicine (TCM) interventions are widely used for FM, but outcome measures in clinical trials are highly inconsistent, limiting evidence synthesis and clinical application.
Several core outcome sets (COS) for fibromyalgia have been developed and registered in the COMET database, providing consensus based western medicine oriented core outcomes for fibromyalgia clinical trials. Nevertheless, these existing COS lack outcome domains reflecting the clinical characteristics of traditional Chinese medicine (TCM), which limits comprehensive effect evaluation for trials of TCM physical interventions. This study aims to develop a TCM add on COS for fibromyalgia trials of acupuncture, tuina and other traditional Chinese physical manipulations. The existing published fibromyalgia COS from the COMET database will be adopted as the foundational reference. Rather than duplicating previously consensus reached outcomes, this add on COS will identify supplementary TCM specific outcome domains and assessment items that are not captured by current fibromyalgia COS. A multi stage modified Delphi method combined with consensus meeting will be implemented. Potential TCM specific outcomes will be extracted from systematic reviews, clinical guidelines and semi structured interviews with patients, TCM clinicians and methodologists. Stakeholders including patients, acupuncturists, tuina practitioners, rheumatologists and trial methodologists will participate in two round Delphi surveys to rate the importance of candidate outcomes. Outcomes reaching pre defined consensus criteria will constitute the final TCM add on COS. This add on COS will complement existing fibromyalgia COS and facilitate complete, standardised outcome reporting for clinical trials assessing acupuncture, tuina and other Chinese physical manipulations for fibromyalgia.
Zhang Yuling Beichen TCM Hospital Affiliated to Tianjin University of Traditional Chinese Medicine
Disease Category: Rheumatology
Disease Name: Fibromyalgia
Age Range: 18 - 85
Sex: Either
Nature of Intervention: Traditional Chinese Medicine
- Clinical experts
- Conference participants
- Epidemiologists
- Ethicists
- Journal editors
- Patient/ support group representatives
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Interview
- Literature review
- Semi structured discussion
- Survey
- Systematic review