Last updated: November 6, 2023
Sponsor: Chinese University of Hong Kong
Overall Status: Active - Recruiting
Phase
N/A
Condition
Chronic Pain
Fibromyalgia
Pain
Treatment
N/AClinical Study ID
NCT05678387
2022.469
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participants with Chronic Widespread pain Participants will be asked, "In the past 3 months, have you had pain in your muscles,bones and joints lasting at least 1 week?", as a screening question for CWP. To meetthe criteria for CWP, subjects have to report musculoskeletal pain in at least 4 of 5body regions and in at least 3 or more body quadrants (as defined byupper-lower/left-right side of the body) and axial skeleton (neck, back, chest, andabdomen), with pain duration of more than 3 months. A Widespread Pain Index (WPI) willbe generated based on the number of pain sites. Subgroup of patients with fibromyalgiawill be identified according to The American College of Rheumatology 2016 whensubjects WPI of ≥ 7 and a symptom severity scale (SSS) score of ≥ 5 or a WPI between 4and 6 and an SSS score of ≥ 9.
- Healthy Participants Healthy participants will be those without chronic pain and depression. A screeningquestion 'In the past 3 months, have you had pain in your muscles, bones and joints lastingat least 1 week?' will be asked to determine whether participant has chronic pain.Depression status will be determined by the questionnaire "Patient Health Questionnaire-9"
Exclusion
Exclusion Criteria:
- Participants with major chronic illnesses, such as malignancy, active inflammatorydiseases, autoimmune diseases and metabolic diseases such as diabetes mellitus andthyroid diseases etc.; use of antibiotics, probiotics or prebiotics in the preceding 2months, any acute illness in the preceding month, change in regularly taken medicationin the preceding month, and substantial dietary alterations in the preceding month.
Study Design
Total Participants: 240
Study Start date:
May 01, 2023
Estimated Completion Date:
May 01, 2025
Study Description
Connect with a study center
Chinese University of Hong Kong
Sha Tin,
Hong KongActive - Recruiting
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