COMT and IL6 Genotype-Phenotype Associations in Fibromyalgia and Myofascial Pain Syndrome
Key facts
- Who runs it
- Istanbul Aydın University
- Where
- Türkiye1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 50 people enrolled
- Started
- 19 Mar 2026
- Ended
- 20 Jul 2026
- Type of study
- Observational, 2 groups
- Record updated
- 25 September 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Adults diagnosed with fibromyalgia (FM) according to the 2016 revised American College of Rheumatology (ACR) diagnostic criteria; or
- Adults diagnosed with myofascial pain syndrome (MPS) based on standardized clinical examination, including identification of a symptomatic muscle, palpable taut band, and clinically relevant myofascial trigger point. Musculoskeletal ultrasonography was additionally performed in all participants with MPS as a supportive phenotyping method
- Ability to understand and complete the clinical assessment questionnaires
- Provision of written informed consent for participation and genetic analysis
Who cannot take part
- Presence of both fibromyalgia and myofascial pain syndrome or fulfillment of the 2016 revised ACR criteria for fibromyalgia in participants considered for the MPS group
- Presence of another medical, neurological, rheumatological, or musculoskeletal condition that could substantially interfere with pain assessment or clinical phenotyping
- Inability to complete the study assessments
- Insufficient or unsuitable blood sample for genetic analysis
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Fibromyalgia (FM) and myofascial pain syndrome (MPS) are chronic pain conditions that may share some clinical features but differ in the distribution and extent of pain and associated symptoms. The biological factors contributing to these differences remain incompletely understood.
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This observational study aims to compare the distribution of two pain-related genetic variants, COMT rs4680 and IL6 rs1800795, between individuals with FM and MPS and to investigate their associations with clinical characteristics. Participants will undergo standardized clinical assessment, including measures of symptom burden, physical functioning, and energy/fatigue. In participants with MPS, musculoskeletal ultrasonography will be used as an adjunct to clinical examination to support phenotypic characterization.
Genetic analysis will be performed using DNA obtained from peripheral venous blood. COMT rs4680 and IL6 rs1800795 will be genotyped using a TaqMan probe-based real-time polymerase chain reaction method.
The study is intended to explore genotype-phenotype associations in two clinically characterized chronic pain conditions. The investigated genetic variants are not being evaluated as diagnostic tests, and no intervention is assigned as part of the study.
The 2 groups in the trial
- Fibromyalgia
Participants diagnosed with fibromyalgia according to the 2016 revised American College of Rheumatology diagnostic criteria. Participants will undergo clinical assessment and genotyping of COMT rs4680 and IL6 rs1800795.
- Myofascial Pain Syndrome
Participants with myofascial pain syndrome identified through standardized clinical examination. Musculoskeletal ultrasonography will be performed in all participants in this group as an adjunct to clinical examination to support phenotypic characterization. Participants will undergo the same clinical assessment and genotyping of COMT rs4680 and IL6 rs1800795.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- INTEGRATING ULTRASOUND-SUPPORTED PHENOTYPING WITH COMT RS4680 AND IL6 RS1800795 GENOTYPE-PHENOTYPE ASSOCIATIONS İN FIBROMYALGIA AND MYOFASCIAL PAIN SYNDROME
- Record updated
- 25 September 2026