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Not yet recruiting NCT07640607

Investigation of Pain Modulation Phenotypes in Female Patients With Fibromyalgia

— Observational Fibromyalgia (FM) Quantitative Sensory Testing Central Sensitization PRESSURE PAIN THRESHOLD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Quantitative Sensory Tests(QST) protocol, Clinical Scales.
Who it may be relevant to
Registry conditions: Fibromyalgia (FM), Quantitative Sensory Testing, Central Sensitization, PRESSURE PAIN THRESHOLD. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Quantitative Sensory Tests(QST) protocol
    including PPT Measurement with an Algometer, CPM and the Slow-Repeated Stimulated Pain Assessment Protocol
  • Other Clinical Scales
    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

Primary outcome measures

  • Conditioned Pain Modulation [Time frame: Baseline]
Secondary outcome measures (9)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 33918736
  • 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
  • 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
  • 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
  • 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. PMID 38279393
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07640607 · 2026-94

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗