Investigation of Pain Modulation Phenotypes in Female Patients With Fibromyalgia
6 juli 2026 bijgewerkt door: Feyza Nur Yucel, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Geschat)
82
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Feyza Nur Yücel, Assoc. Prof.
- Telefoonnummer: +90 (0216) 542 20 00
- E-mail: dr.fny28@gmail.com
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
The study population will consist of female patients who presented to the Physical Medicine and Rehabilitation Clinic and received a diagnosis of FM.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Patient
Women with Fibromyalgia
|
including PPT Measurement with an Algometer, CPM and the Slow-Repeated Stimulated Pain Assessment Protocol
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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Conditioned Pain Modulation
Tijdsspanne: 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.
|
Baseline
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Pressure Pain Threshold
Tijdsspanne: Baseline
|
Lower values are associated with pain sensitization
|
Baseline
|
|
Slowly Repeated Evoked Pain Assessment Protocol
Tijdsspanne: Baseline
|
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.
|
Baseline
|
|
Central Sensitization Inventory
Tijdsspanne: Baseline
|
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 .
|
Baseline
|
|
Revised Fibromyalgia Impact Questionnaire
Tijdsspanne: Baseline
|
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.
|
Baseline
|
|
Self-administered Leeds Assessment of Neuropathic Symptoms and Signs
Tijdsspanne: Baseline
|
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 .
|
Baseline
|
|
Tampa Kinesiophobia Scale
Tijdsspanne: Baseline
|
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.
|
Baseline
|
|
Hospital Anxiety and Depression Scale
Tijdsspanne: Baseline
|
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.
|
Baseline
|
|
SF-12 Quality of Life Scale
Tijdsspanne: Baseline
|
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.
|
Baseline
|
|
Fatigue Severity Scale
Tijdsspanne: Baseline
|
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.
|
Baseline
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Feyza Nur Yücel, Assoc. Prof., Saglik Bilimleri Universitesi
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 juli 2026
Primaire voltooiing (Geschat)
30 augustus 2026
Studie voltooiing (Geschat)
1 september 2026
Studieregistratiedata
Eerst ingediend
1 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
5 juni 2026
Eerst geplaatst (Werkelijk)
11 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
7 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
6 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Musculoskeletale aandoeningen
- Ziekten van het zenuwstelsel
- Spierziekten
- Neuromusculaire aandoeningen
- Reumatische aandoeningen
- Fibromyalgie
- Kwaliteit, toegang en evaluatie van de gezondheidszorg
- Therapeutica
- Evaluatiemechanismen voor gezondheidszorg
- Kwaliteit van de gezondheidszorg
- Epidemiologische studie -kenmerken
- Klinische protocollen
Andere studie-ID-nummers
- 2026-94
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
Individual participant data collected during this study will not be made available to other researchers.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .