Fibromyalgia (FM)NCT07640607
Investigation of Pain Modulation Phenotypes in Female Patients With Fibromyalgia
An observational study of Fibromyalgia (FM) and Quantitative Sensory Testing, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey.
Trial summary
Fibromyalgia is characterized by altered pain processing, including impaired descending pain inhibition and central sensitization. While both mechanisms have been independently associated with disease severity, their interrelationship remains unclear. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia (FM), Quantitative Sensory Testing, Central Sensitization
- What is being tested?
- Quantitative Sensory Tests(QST) protocol and Clinical Scales
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of female patients who presented to the Physical Medicine and Rehabilitation Clinic and received a diagnosis of FM.
Who may be able to join
- Having received a diagnosis of fibromyalgia according to the 2016 ACR diagnostic criteria
- Female patients aged 18-65
- Being literate
- Having signed the informed consent form upon agreeing to participate in the study
Who cannot join
- Being under 18 or over 65 years of age
- Having any condition that may lower the pain threshold or cause chronic pain (Rheumatoid Arthritis, Ankylosing Spondylitis, systemic inflammatory diseases, malignancies, etc.)
- Any neurological condition (stroke, traumatic brain injury, multiple sclerosis, Parkinson's disease, central nervous system malignancies…)
- Peripheral artery disease
- Severe cardiopulmonary insufficiency (stage 3-4)
- Uncontrolled systemic diseases such as hypertension and diabetes
Show all 9Show fewer
- Presence of an active infection
- Pregnancy
- Presence of cognitive impairment, hearing loss, or communication difficulties that would prevent understanding of questionnaires and protocols
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Fibromyalgia is characterized by altered pain processing, including impaired descending pain inhibition and central sensitization. While both mechanisms have been independently associated with disease severity, their interrelationship remains unclear. This cross-sectional study aims to investigate whether central sensitization symptoms mediate the relationship between conditioned pain modulation and fibromyalgia impact.
Read the detailed description
Fibromyalgia is characterized by altered pain processing mechanisms, including impaired descending pain inhibition and central sensitization. Although both mechanisms have been independently associated with symptom severity and functional impairment, their interrelationship and relative contributions to disease impact are not fully understood.
This study aims to examine the associations between conditioned pain modulation, central sensitization symptoms, and fibromyalgia impact. In particular, the study evaluates whether central sensitization symptoms act as a mediator in the relationship between impaired pain modulation and clinical disease burden. Participants with fibromyalgia are assessed using standardized clinical and psychological measures, including the Fibromyalgia Impact Questionnaire, Central Sensitization Inventory, and Hospital Anxiety and Depression Scale. Quantitative sensory testing is performed to evaluate conditioned pain modulation, pressure pain threshold, and temporal summation.Statistical analyses are conducted to explore bivariate associations and to identify independent predictors of fibromyalgia impact. A mediation framework is applied to assess whether central sensitization symptoms explain the relationship between pain modulation and clinical outcomes.
- Conditions
- Fibromyalgia (FM), Quantitative Sensory Testing, Central Sensitization, PRESSURE PAIN THRESHOLD, Pain Perception
- Being tested
- Quantitative Sensory Tests(QST) protocol, Clinical Scales
- Keywords
- Fibromyalgia, Pain sensitization, Conditioned pain modulation
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Sensory Tests(QST) protocolOther
including PPT Measurement with an Algometer, CPM and the Slow-Repeated Stimulated Pain Assessment Protocol
Clinical ScalesOther
Central Sensitization Inventory, Revised Fibromyalgia Impact Questionnaire, S-LANSS, Tampa Kinesiophobia Scale, Hospital Anxiety and Depression Scale, SF-12 Quality of Life Scale and Fatigue Severity Scale
| Study group | Role | What they receive |
|---|---|---|
| Patient | Women with Fibromyalgia Receives: Other: Quantitative Sensory Tests(QST) protocol; Other: Clinical Scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conditioned Pain Modulation
Objective determination of the pain modulation phenotype and the severity of central sensitization. Scores above 100 are considered a normal CPM response; higher scores indicate greater pain inhibition.
Measured: Baseline
Secondary outcomes (9)
Pressure Pain Threshold
Lower values are associated with pain sensitization
Measured: Baseline
Slowly Repeated Evoked Pain Assessment Protocol
The SREP protocol consists of 9 painful stimuli above the pain threshold, each applied to the nail for 5 seconds at approximately 30-second intervals.
Measured: Baseline
Central Sensitization Inventory
It is preferred for investigating pain sensitivity through symptoms associated with CS and related comorbidities. CS severity can be classified into 5 different groups based on the score obtained from Section A of the scale: scores of 0-21 indicate a subclinical level, 22-30 indicate a mild level, 31-37 indicate a moderate level, 38-51 indicate a severe level, and scores above 51 indicate a very severe level of CS .
Measured: Baseline
Revised Fibromyalgia Impact Questionnaire
It consists of three sections-daily physical activities, general condition, and symptoms-and a total of 21 questions. It assesses limitations and functional disability in patients with fibromyalgia. All questions are rated on a 0-10-point Visual Analog Scale (VAS). A higher total score indicates an increase in disability associated with fibromyalgia.
Measured: Baseline
Self-administered Leeds Assessment of Neuropathic Symptoms and Signs
The Neuropathic Symptoms and Signs Questionnaire is a 7-item self-report questionnaire completed by the individual, scored on a scale of 0 to 24. A score of 12 or higher indicates the likelihood of neuropathic pain .
Measured: Baseline
Tampa Kinesiophobia Scale
A 17-item questionnaire developed to measure the fear of movement and re-injury . The total score ranges from 17 to 68. Higher scores are associated with an increase in kinesiophobia.
Measured: Baseline
Hospital Anxiety and Depression Scale
It consists of a total of 14 items, with 7 items each for anxiety and depression. Scores for the anxiety and depression subscales range from 0 to 21. Scores between 8 and 10 indicate moderate symptom presence, while a score greater than 11 indicates anxiety and depression symptoms that likely correspond to a clinical diagnosis.
Measured: Baseline
SF-12 Quality of Life Scale
It was developed to assess health-related quality of life. Two separate scores are obtained: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The physical score reflects the individual's perception of overall health, physical limitations, and pain levels. The mental score, on the other hand, reflects the individual's emotional problems, energy levels, and social activities.
Measured: Baseline
Fatigue Severity Scale
This is a 9-item questionnaire in which each item is rated on a scale of 1 to 7; it assesses the severity, frequency, and impact of fatigue on daily life. The total score ranges from 7 to 63. As the score decreases, fatigue decreases.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Fibromyalgia (FM)Studies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feyza Nur Yucel, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Investigators
- Feyza Nur Yücel, Assoc. Prof., Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640607
- Sponsor's protocol ID
- 2026-94
- Status last verified
- Jul 2026
- First submitted
- 1 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during this study will not be made available to other researchers.
Publications
Siracusa R, Paola RD, Cuzzocrea S, Impellizzeri D. Fibromyalgia: Pathogenesis, Mechanisms, Diagnosis and Treatment Options Update. Int J Mol Sci. 2021 Apr 9;22(8):3891. doi: 10.3390/ijms22083891.
PubMed 33918736Ruschak I, Monteso-Curto P, Rossello L, Aguilar Martin C, Sanchez-Monteso L, Toussaint L. Fibromyalgia Syndrome Pain in Men and Women: A Scoping Review. Healthcare (Basel). 2023 Jan 11;11(2):223. doi: 10.3390/healthcare11020223.
PubMed 36673591Vincent A, Lahr BD, Wolfe F, Clauw DJ, Whipple MO, Oh TH, Barton DL, St Sauver J. Prevalence of fibromyalgia: a population-based study in Olmsted County, Minnesota, utilizing the Rochester Epidemiology Project. Arthritis Care Res (Hoboken). 2013 May;65(5):786-92. doi: 10.1002/acr.21896.
PubMed 23203795Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016 Dec;46(3):319-329. doi: 10.1016/j.semarthrit.2016.08.012. Epub 2016 Aug 30.
PubMed 27916278Nijs J, George SZ, Clauw DJ, Fernandez-de-Las-Penas C, Kosek E, Ickmans K, Fernandez-Carnero J, Polli A, Kapreli E, Huysmans E, Cuesta-Vargas AI, Mani R, Lundberg M, Leysen L, Rice D, Sterling M, Curatolo M. Central sensitisation in chronic pain conditions: latest discoveries and their potential for precision medicine. Lancet Rheumatol. 2021 May;3(5):e383-e392. doi: 10.1016/S2665-9913(21)00032-1. Epub 2021 Mar 30.
PubMed 38279393Jurado-Priego LN, Cueto-Urena C, Ramirez-Exposito MJ, Martinez-Martos JM. Fibromyalgia: A Review of the Pathophysiological Mechanisms and Multidisciplinary Treatment Strategies. Biomedicines. 2024 Jul 11;12(7):1543. doi: 10.3390/biomedicines12071543.
PubMed 39062116Maquet D, Croisier JL, Demoulin C, Crielaard JM. Pressure pain thresholds of tender point sites in patients with fibromyalgia and in healthy controls. Eur J Pain. 2004 Apr;8(2):111-7. doi: 10.1016/S1090-3801(03)00082-X.
PubMed 14987620Yarnitsky D, Bouhassira D, Drewes AM, Fillingim RB, Granot M, Hansson P, Landau R, Marchand S, Matre D, Nilsen KB, Stubhaug A, Treede RD, Wilder-Smith OH. Recommendations on practice of conditioned pain modulation (CPM) testing. Eur J Pain. 2015 Jul;19(6):805-6. doi: 10.1002/ejp.605. Epub 2014 Oct 20.
PubMed 25330039de la Coba P, Bruehl S, Del Paso GAR. Addition of Slowly Repeated Evoked Pain Responses to Clinical Symptoms Enhances Fibromyalgia Diagnostic Accuracy. Pain Med. 2020 Dec 25;21(12):3479-3487. doi: 10.1093/pm/pnz346.
PubMed 32022855
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pain Modulation Phenotypes in Female Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT07640607
- Acronym / sponsor ID
- 2026-94
- Conditions
- Fibromyalgia (FM), Quantitative Sensory Testing, Central Sensitization, PRESSURE PAIN THRESHOLD, Pain Perception
- Keywords
- Fibromyalgia, Pain sensitization, Conditioned pain modulation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 11 Jun 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 is characterized by altered pain processing, including impaired descending pain inhibition and central sensitization. While both mechanisms have been independently associated with disease severity, their interrelationship remains unclear. This cross-sectional study aims to investigate whether central sensitization symptoms mediate the relationship between conditioned pain modulation and fibromyalgia impact.
Detailed description
Fibromyalgia is characterized by altered pain processing mechanisms, including impaired descending pain inhibition and central sensitization. Although both mechanisms have been independently associated with symptom severity and functional impairment, their interrelationship and relative contributions to disease impact are not fully understood.
This study aims to examine the associations between conditioned pain modulation, central sensitization symptoms, and fibromyalgia impact. In particular, the study evaluates whether central sensitization symptoms act as a mediator in the relationship between impaired pain modulation and clinical disease burden. Participants with fibromyalgia are assessed using standardized clinical and psychological measures, including the Fibromyalgia Impact Questionnaire, Central Sensitization Inventory, and Hospital Anxiety and Depression Scale. Quantitative sensory testing is performed to evaluate conditioned pain modulation, pressure pain threshold, and temporal summation.Statistical analyses are conducted to explore bivariate associations and to identify independent predictors of fibromyalgia impact. A mediation framework is applied to assess whether central sensitization symptoms explain the relationship between pain modulation and clinical outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: Quantitative Sensory Tests(QST) protocol, Other: Clinical ScalesWomen with Fibromyalgia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of female patients who presented to the Physical Medicine and Rehabilitation Clinic and received a diagnosis of FM.
Key inclusion criteria (4 listed)
- Having received a diagnosis of fibromyalgia according to the 2016 ACR diagnostic criteria
- Female patients aged 18-65
- Being literate
- Having signed the informed consent form upon agreeing to participate in the study
Key exclusion criteria (9 listed)
- Being under 18 or over 65 years of age
- Having any condition that may lower the pain threshold or cause chronic pain (Rheumatoid Arthritis, Ankylosing Spondylitis, systemic inflammatory diseases, malignancies, etc.)
- Any neurological condition (stroke, traumatic brain injury, multiple sclerosis, Parkinson's disease, central nervous system malignancies…)
- Peripheral artery disease
- Severe cardiopulmonary insufficiency (stage 3-4)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative Sensory Tests(QST) protocolincluding PPT Measurement with an Algometer, CPM and the Slow-Repeated Stimulated Pain Assessment Protocol | Other | Patient |
| Clinical ScalesCentral Sensitization Inventory, Revised Fibromyalgia Impact Questionnaire, S-LANSS, Tampa Kinesiophobia Scale, Hospital Anxiety and Depression Scale, SF-12 Quality of Life Scale and Fatigue Severity Scale | Other | Patient |
Primary outcome
Conditioned Pain Modulation
Time frame: Baseline
Objective determination of the pain modulation phenotype and the severity of central sensitization. Scores above 100 are considered a normal CPM response; higher scores indicate greater pain inhibition.
9 secondary outcomes
Pressure Pain Threshold
Time frame: Baseline
Slowly Repeated Evoked Pain Assessment Protocol
Time frame: Baseline
Central Sensitization Inventory
Time frame: Baseline
Revised Fibromyalgia Impact Questionnaire
Time frame: Baseline
Self-administered Leeds Assessment of Neuropathic Symptoms and Signs
Time frame: Baseline
Tampa Kinesiophobia Scale
Time frame: Baseline
Hospital Anxiety and Depression Scale
Time frame: Baseline
SF-12 Quality of Life Scale
Time frame: Baseline
Fatigue Severity Scale
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 33918736Siracusa R, Paola RD, Cuzzocrea S, Impellizzeri D. Fibromyalgia: Pathogenesis, Mechanisms, Diagnosis and Treatment Options Update. Int J Mol Sci. 2021 Apr 9;22(8):3891. doi: 10.3390/ijms22083891.
- Background: PubMed 36673591Ruschak I, Monteso-Curto P, Rossello L, Aguilar Martin C, Sanchez-Monteso L, Toussaint L. Fibromyalgia Syndrome Pain in Men and Women: A Scoping Review. Healthcare (Basel). 2023 Jan 11;11(2):223. doi: 10.3390/healthcare11020223.
- Background: PubMed 23203795Vincent A, Lahr BD, Wolfe F, Clauw DJ, Whipple MO, Oh TH, Barton DL, St Sauver J. Prevalence of fibromyalgia: a population-based study in Olmsted County, Minnesota, utilizing the Rochester Epidemiology Project. Arthritis Care Res (Hoboken). 2013 May;65(5):786-92. doi: 10.1002/acr.21896.
- Background: PubMed 27916278Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016 Dec;46(3):319-329. doi: 10.1016/j.semarthrit.2016.08.012. Epub 2016 Aug 30.
- Background: PubMed 38279393Nijs J, George SZ, Clauw DJ, Fernandez-de-Las-Penas C, Kosek E, Ickmans K, Fernandez-Carnero J, Polli A, Kapreli E, Huysmans E, Cuesta-Vargas AI, Mani R, Lundberg M, Leysen L, Rice D, Sterling M, Curatolo M. Central sensitisation in chronic pain conditions: latest discoveries and their potential for precision medicine. Lancet Rheumatol. 2021 May;3(5):e383-e392. doi: 10.1016/S2665-9913(21)00032-1. Epub 2021 Mar 30.
- Background: PubMed 39062116Jurado-Priego LN, Cueto-Urena C, Ramirez-Exposito MJ, Martinez-Martos JM. Fibromyalgia: A Review of the Pathophysiological Mechanisms and Multidisciplinary Treatment Strategies. Biomedicines. 2024 Jul 11;12(7):1543. doi: 10.3390/biomedicines12071543.
- Background: PubMed 14987620Maquet D, Croisier JL, Demoulin C, Crielaard JM. Pressure pain thresholds of tender point sites in patients with fibromyalgia and in healthy controls. Eur J Pain. 2004 Apr;8(2):111-7. doi: 10.1016/S1090-3801(03)00082-X.
- Background: PubMed 25330039Yarnitsky D, Bouhassira D, Drewes AM, Fillingim RB, Granot M, Hansson P, Landau R, Marchand S, Matre D, Nilsen KB, Stubhaug A, Treede RD, Wilder-Smith OH. Recommendations on practice of conditioned pain modulation (CPM) testing. Eur J Pain. 2015 Jul;19(6):805-6. doi: 10.1002/ejp.605. Epub 2014 Oct 20.
- Background: PubMed 32022855de la Coba P, Bruehl S, Del Paso GAR. Addition of Slowly Repeated Evoked Pain Responses to Clinical Symptoms Enhances Fibromyalgia Diagnostic Accuracy. Pain Med. 2020 Dec 25;21(12):3479-3487. doi: 10.1093/pm/pnz346.
- Individual participant dataSharing planned: No. Individual participant data collected during this study will not be made available to other researchers.
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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.
Feyza Nur Yücel, Assoc. Prof. principal investigator
Saglik Bilimleri Universitesi
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia (FM) and Quantitative Sensory Testing, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey.
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 9 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: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feyza Nur Yücel, Assoc. Prof. ((0216) 542 20 00 ext. +90, dr.fny28@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conditioned Pain Modulation (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07640607, which also lists 9 linked publications.
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 7 Jul 2026.