Fibromyalgia SyndromeNCT07840963
COMT and IL6 Genotype-Phenotype Associations in Fibromyalgia and Myofascial Pain Syndrome
An observational study of Fibromyalgia Syndrome and Myofascial Pain Syndrome (MPS), run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia Syndrome, Myofascial Pain Syndrome (MPS)
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Mar 2026to 20 Jul 2026
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of adults diagnosed with fibromyalgia (FM) or myofascial pain syndrome (MPS). The study included 50 participants, with 25 participants in each diagnostic group. FM was diagnosed according to the 2016 revised American College of Rheumatology criteria. MPS was diagnosed based on standardized clinical examination, followed by musculoskeletal ultrasonography in all participants with MPS as an adjunct to clinical assessment.
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: INTEGRATING ULTRASOUND-SUPPORTED PHENOTYPING WITH COMT RS4680 AND IL6 RS1800795 GENOTYPE-PHENOTYPE ASSOCIATIONS İN FIBROMYALGIA AND MYOFASCIAL PAIN SYNDROME
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.
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.
Read more
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.
Read the detailed description
This comparative observational study will include 50 participants, comprising 25 individuals with fibromyalgia (FM) and 25 individuals with myofascial pain syndrome (MPS).
FM will be diagnosed according to the 2016 revised American College of Rheumatology diagnostic criteria. MPS classification will be based on a standardized sequential assessment consisting of clinical examination followed by musculoskeletal ultrasonography. Clinical examination will be performed to identify the symptomatic muscle, palpable taut band, and clinically relevant myofascial trigger point. Ultrasonography will subsequently be performed in all participants classified as having MPS and will be used as an adjunct to clinical examination rather than as a standalone diagnostic test.
Clinical assessment will include the Revised Fibromyalgia Impact Questionnaire (FIQR), Symptom Severity Scale (SSS), and the Physical Functioning and Energy/Fatigue domains of the 36-Item Short Form Health Survey (SF-36).
Peripheral venous blood samples will be obtained for DNA extraction. COMT rs4680 and IL6 rs1800795 polymorphisms will be genotyped using TaqMan probe-based real-time PCR. Genotype distributions will be compared between FM and MPS, and associations between genotype categories and clinical measures will be explored.
The study is designed as a hypothesis-driven candidate-gene association study and does not aim to establish either polymorphism as a diagnostic genetic marker.
- Keywords
- fibromyalgia, myofascial Pain Syndrome, COMT, IL-6, Polymorphism, nociplastic pain, chronic pain, musculoskeletal ultrasonography, genotype-phenotype association
- Medical subject headings
- Fibromyalgia, Myofascial Pain Syndromes, Nociplastic Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
COMT rs4680
Genotype frequencies of COMT rs4680 (AA, AG, and GG) will be determined by TaqMan probe-based real-time PCR and compared between participants with fibromyalgia and myofascial pain syndrome.
Measured: At study enrollment/baseline assessment
IL6 rs1800795 Genotype Distributions
Genotype frequencies of IL6 rs1800795 (CC, CG, and GG) will be determined by TaqMan probe-based real-time PCR and compared between participants with fibromyalgia and myofascial pain syndrome.
Measured: At study enrollment/baseline assessment
Secondary outcomes (4)
FIQR Score
The Revised Fibromyalgia Impact Questionnaire will be used to assess symptom and functional burden. Scores will be compared between diagnostic groups and explored across genotype categories.
Measured: At baseline assessment
Symptom Severity Scale Score
Symptom Severity Scale scores will be assessed and compared between diagnostic and genotype groups.
Measured: At baseline assessment
SF-36 Physical Functioning Score
Physical functioning will be assessed using the Physical Functioning domain of the SF-36.
Measured: At baseline assessment
SF-36 Energy/Fatigue Score
Energy/fatigue will be assessed using the Energy/Fatigue domain of the SF-36.
Measured: At baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start19 Mar 2026
- Primary completion20 Jul 2026
- Study completion20 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gökhan ÖZKOÇAK, Istanbul Aydın University
- Investigators
- Gökhan Özkoçak, Principal investigator, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840963
- Sponsor's protocol ID
- E-10840098-50.04.2129
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available because the dataset includes sensitive genetic information and the informed consent obtained from participants did not include provisions for public sharing of individual-level genetic data. Aggregated and de-identified study results will be reported in scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTEGRATING ULTRASOUND-SUPPORTED PHENOTYPING WITH COMT RS4680 AND IL6 RS1800795 GENOTYPE-PHENOTYPE ASSOCIATIONS İN FIBROMYALGIA AND MYOFASCIAL PAIN SYNDROME
- ClinicalTrials.gov ID
- NCT07840963
- Acronym / sponsor ID
- E-10840098-50.04.2129
- Keywords
- fibromyalgia, myofascial Pain Syndrome, COMT, IL-6, Polymorphism, nociplastic pain, chronic pain, musculoskeletal ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 20 Jul 2026 (actual)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Detailed description
This comparative observational study will include 50 participants, comprising 25 individuals with fibromyalgia (FM) and 25 individuals with myofascial pain syndrome (MPS).
FM will be diagnosed according to the 2016 revised American College of Rheumatology diagnostic criteria. MPS classification will be based on a standardized sequential assessment consisting of clinical examination followed by musculoskeletal ultrasonography. Clinical examination will be performed to identify the symptomatic muscle, palpable taut band, and clinically relevant myofascial trigger point. Ultrasonography will subsequently be performed in all participants classified as having MPS and will be used as an adjunct to clinical examination rather than as a standalone diagnostic test.
Clinical assessment will include the Revised Fibromyalgia Impact Questionnaire (FIQR), Symptom Severity Scale (SSS), and the Physical Functioning and Energy/Fatigue domains of the 36-Item Short Form Health Survey (SF-36).
Peripheral venous blood samples will be obtained for DNA extraction. COMT rs4680 and IL6 rs1800795 polymorphisms will be genotyped using TaqMan probe-based real-time PCR. Genotype distributions will be compared between FM and MPS, and associations between genotype categories and clinical measures will be explored.
The study is designed as a hypothesis-driven candidate-gene association study and does not aim to establish either polymorphism as a diagnostic genetic marker.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adults diagnosed with fibromyalgia (FM) or myofascial pain syndrome (MPS). The study included 50 participants, with 25 participants in each diagnostic group. FM was diagnosed according to the 2016 revised American College of Rheumatology criteria. MPS was diagnosed based on standardized clinical examination, followed by musculoskeletal ultrasonography in all participants with MPS as an adjunct to clinical assessment.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
COMT rs4680
Time frame: At study enrollment/baseline assessment
Genotype frequencies of COMT rs4680 (AA, AG, and GG) will be determined by TaqMan probe-based real-time PCR and compared between participants with fibromyalgia and myofascial pain syndrome.
IL6 rs1800795 Genotype Distributions
Time frame: At study enrollment/baseline assessment
Genotype frequencies of IL6 rs1800795 (CC, CG, and GG) will be determined by TaqMan probe-based real-time PCR and compared between participants with fibromyalgia and myofascial pain syndrome.
4 secondary outcomes
FIQR Score
Time frame: At baseline assessment
Symptom Severity Scale Score
Time frame: At baseline assessment
SF-36 Physical Functioning Score
Time frame: At baseline assessment
SF-36 Energy/Fatigue Score
Time frame: At baseline assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available because the dataset includes sensitive genetic information and the informed consent obtained from participants did not include provisions for public sharing of individual-level genetic data. Aggregated and de-identified study results will be reported in scientific publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gökhan Özkoçak principal investigator
Istanbul Aydın University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia Syndrome and Myofascial Pain Syndrome (MPS), run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COMT rs4680 (time frame: At study enrollment/baseline assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.