ClinicalTrials.gg
CompletedNCT07840963Updated Sep 25, 2026

COMT and IL6 Genotype-Phenotype Associations in Fibromyalgia and Myofascial Pain Syndrome

An observational study in Fibromyalgia Syndrome and Myofascial Pain Syndrome (MPS), sponsored by Istanbul Aydın University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Istanbul Aydın University · Observational

Updated Sep 25, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
50
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 195 studies in Fibromyalgia with a site in Turkey — 51 open to participants now, 55 under way, none of them phase 3. Fibromyalgia · Turkey.

Enrollment
77th of 91
50 · median 100
Started
2026
with 24 others
Observational
91 of 195
25 open now
Registered
190th of 195
by date

Among the 195 studies in Fibromyalgia with a site in Turkey, this one is the 77th largest by enrollment of the 91 observational ones, is one of 25 that started in 2026, is one of 91 observational ones, and was the 190th registered.

By phase

195 studies; the count open now beside each. This study's row is marked.

No phase102 · 25 open
Observationalthis study91 · 25 open
Phase 11 · 1 open
Phase 2/31 · 0 open

By the year they started

First in 2003; this study’s year is marked. 25 started in 2026.

Size and results

Median enrollment 52 across the 104 interventional studies, 100 across the 91 observational. Of the 126 that completed or were terminated, 3 (2%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 195 studies in Fibromyalgia with a site in Turkey, or all of them as a file.
02

Study 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.

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.

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.

03

Conditions studied

  • Fibromyalgia Syndrome
  • Myofascial Pain Syndrome (MPS)

Keywords

  • fibromyalgia
  • myofascial Pain Syndrome
  • COMT
  • IL-6
  • Polymorphism
  • nociplastic pain
  • chronic pain
  • musculoskeletal ultrasonography
  • genotype-phenotype association
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 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 for participation and genetic analysis.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
50 participants (actual)
Target follow-up
2 Weeks
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At study enrollment/baseline assessment

  2. 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.

    Time frame: At study enrollment/baseline assessment

Secondary outcomes

  1. 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.

    Time frame: At baseline assessment

  2. Symptom Severity Scale Score

    Symptom Severity Scale scores will be assessed and compared between diagnostic and genotype groups.

    Time frame: At baseline assessment

  3. SF-36 Physical Functioning Score

    Physical functioning will be assessed using the Physical Functioning domain of the SF-36.

    Time frame: At baseline assessment

  4. SF-36 Energy/Fatigue Score

    Energy/fatigue will be assessed using the Energy/Fatigue domain of the SF-36.

    Time frame: At baseline assessment

07

Study locations

1 site
  • Istanbul Aydın University
    Istanbul, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2026 to primary completion in Jul 2026, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2026
First posted
Sep 25, 2026
StartActual
Mar 19, 2026
Primary completionActual
Jul 20, 2026
CompletionActual
Jul 20, 2026
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07840963
Lead sponsor
Istanbul Aydın University
Responsible party
Gökhan ÖZKOÇAK (Gökhan Özkoçak, Asst. Prof. M.D., Istanbul Aydın University) — Principal investigator
First posted
Sep 25, 2026
Start date
Mar 19, 2026
Primary completion
Jul 20, 2026
Completion
Jul 20, 2026
Last update
Sep 25, 2026

Study contacts

Gökhan Özkoçak
principal investigator · Istanbul Aydın University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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