A prospective observational preliminary study of Korean medicine treatment for patients with fibromyalgia
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0007457
- Lead Sponsor
- Kyung Hee University Oriental Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Patients with fibromyalgia(M79.7) registered as the main diagnosis
- Patients who satisfy 'Widespread pain index(WPI) = 7 and symptom severity scale (SSS) score = 5' or 'WPI 4-6 and SSS score = 9' in the modified 2016 ACR criteria for fibromyalgia.
- Patients who have had general pain(at least 4-5 sites) for more than 3 months.
- Patients over the age of 19 who voluntarily deciede to participate in this clinical study and signed the consent form.
- Patients participating in other clinical studies.
- Patients receiving Korean medicine treatment through other clinics for the purpose of treating fibromyalgia.
- Patients who are expected to have difficulty complying with the clinical study schedule.
- Patients who are expected to have difficulties in understanding and responding to research questionnaires such as illiteracy and mental and physical weakness.
- Patients judged to be difficult to participate in clinical reseach based on the opinion of the researcher.
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umeric rating scale(NRS) (average and most severe pain of the day)
- Secondary Outcome Measures
Name Time Method Revised Fibromyalgia Impact Questionnaire(FIQR), Pain Catastrophizing Scale(PCS), Pain Pressure Threshold(PPT);Beck Depression Inventory(BDI-?), Beck Anxiety inventory(BAI);Emotional response test, Empathy Quotient, Social network survey;Daily Sleep Interference Scale(DSIS), Fatigue Severity Scale(FSS), EuroQol Five dimension scale(EA-5D-5L);Patients’ Global Impression of Change(PGIC)