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Investigation of Pain Modulation Phenotypes in Female Patients With Fibromyalgia

5. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

82

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Feyza Nur Yücel, Assoc. Prof.
  • Telefonnummer: +90 (0216) 542 20 00
  • E-mail: dr.fny28@gmail.com

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study population will consist of female patients who presented to the Physical Medicine and Rehabilitation Clinic and received a diagnosis of FM.

Beskrivelse

Inclusion Criteria:

  1. Having received a diagnosis of fibromyalgia according to the 2016 ACR diagnostic criteria
  2. Female patients aged 18-65
  3. Being literate
  4. Having signed the informed consent form upon agreeing to participate in the study

Exclusion Criteria:

  1. Being under 18 or over 65 years of age
  2. Having any condition that may lower the pain threshold or cause chronic pain (Rheumatoid Arthritis, Ankylosing Spondylitis, systemic inflammatory diseases, malignancies, etc.)
  3. Any neurological condition (stroke, traumatic brain injury, multiple sclerosis, Parkinson's disease, central nervous system malignancies…)
  4. Peripheral artery disease
  5. Severe cardiopulmonary insufficiency (stage 3-4)
  6. Uncontrolled systemic diseases such as hypertension and diabetes
  7. Presence of an active infection
  8. Pregnancy
  9. Presence of cognitive impairment, hearing loss, or communication difficulties that would prevent understanding of questionnaires and protocols

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Patient
Women with Fibromyalgia
Andet: Quantitative Sensory Tests(QST) protocol
including PPT Measurement with an Algometer, CPM and the Slow-Repeated Stimulated Pain Assessment Protocol
Andet: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Conditioned Pain Modulation
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pressure Pain Threshold
Tidsramme: Baseline
Lower values are associated with pain sensitization
Baseline
Slowly Repeated Evoked Pain Assessment Protocol
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Efterforskere

  • Ledende efterforsker: Feyza Nur Yücel, Assoc. Prof., Saglik Bilimleri Universitesi

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

30. august 2026

Studieafslutning (Anslået)

1. september 2026

Datoer for studieregistrering

Først indsendt

1. juni 2026

Først indsendt, der opfyldte QC-kriterier

5. juni 2026

Først opslået (Faktiske)

11. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 222222

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data collected during this study will not be made available to other researchers.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Central sensibilisering

Kliniske forsøg med Quantitative Sensory Tests(QST) protocol

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