Investigation of Pain Modulation Phenotypes in Female Patients With Fibromyalgia

NCT07640607 | Not Yet Recruiting

• 1 other identifier: 2026-94
• Study Type: observational
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief 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. This cross-sectional study aims to investigate whether central sensitization symptoms mediate the relationship between conditioned pain modulation and fibromyalgia impact.

Conditions

Fibromyalgia (FM); Quantitative Sensory Testing; Central Sensitization; PRESSURE PAIN THRESHOLD; Pain Perception

Keywords

Fibromyalgia; Pain sensitization; Conditioned pain modulation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (9)

• Pressure Pain Threshold

  Baseline

• Slowly Repeated Evoked Pain Assessment Protocol

  Baseline

• Central Sensitization Inventory

  Baseline

• Revised Fibromyalgia Impact Questionnaire

  Baseline

• Self-administered Leeds Assessment of Neuropathic Symptoms and Signs

  Baseline

Study Arms (1)

Patient

Women with Fibromyalgia

Other: Quantitative Sensory Tests(QST) protocol; Other: Clinical Scales

Interventions

Quantitative Sensory Tests(QST) protocol OTHER

including PPT Measurement with an Algometer, CPM and the Slow-Repeated Stimulated Pain Assessment Protocol

Patient

Clinical Scales OTHER

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

Patient

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• Presence of an active infection
• Pregnancy
• Presence of cognitive impairment, hearing loss, or communication difficulties that would prevent understanding of questionnaires and protocols

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Related Publications (9)

• 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.

  PMID: 33918736 BACKGROUND

• Ruschak 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.

  PMID: 36673591 BACKGROUND

• Vincent 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.

  PMID: 23203795 BACKGROUND

• Wolfe 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.

  PMID: 27916278 BACKGROUND

• Nijs 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.

  PMID: 38279393 BACKGROUND

• Jurado-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.

  PMID: 39062116 BACKGROUND

• Maquet 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.

  PMID: 14987620 BACKGROUND

• Yarnitsky 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.

  PMID: 25330039 BACKGROUND

• de 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.

  PMID: 32022855 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Feyza Nur Yücel, Assoc. Prof.

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feyza Nur Yücel, Assoc. Prof.

CONTACT

(0216) 542 20 00; dr.fny28@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 11, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share