Pain Phenotypes in Patients with Fibromyalgia Syndrome

NCT ID: NCT05941780

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-10

Study Completion Date

2025-01-30

Brief Summary

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Fibromyalgia Syndrome (FMS); is a complex syndrome characterized by many symptoms such as chronic widespread pain, fatigue and sleep disorders, cognitive dysfunctions and psychiatric disorders. It has been stated that there is an urgent need for studies examining the clinicimetric and psychometric properties of the pain phenotype criteria in terms of patients receiving the most appropriate treatment, clinicians deciding on the appropriate treatment, and contributing to the research of scientists. Despite all this, no study has yet been found that describes the pain phenotypes in fibromyalgia syndrome and how different types of pain affect patients.

The primary aim of this study is to determine the chronic pain phenotypes in individuals with FMS. The secondary aim of this study to determine the inter-rater and intra-rater reliability of the algorithm used in the determination of pain phenotypes and to assessment the clinical effects of different pain phenotypes on individuals with FMS in terms of pain severity, disease severity, quality of life and catastrophe.

Detailed Description

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Conditions

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Fibromyalgia, Primary Fibromyalgia Chronic Pain Syndrome Pain, Neuropathic Nociceptive Pain Central Sensitisation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Pain classification method

A current clinical algorithm will be used to determine the predominant type of pain in individuals with FMS. The classification to diagnose nociceptive, neuropathic and nociplastic pain will based on a recent method developed by Nijs et al. This method consists of seven steps in total. These steps question the following, respectively: duration of pain, pain distribution, presence of nociceptive pain, presence of neuropathic pain, phenomenon of hypersensitivity, presence of hypersensitization and presence of specific comorbidity. Besides, inter-rater and intra-rater reliability of pain classification algorithm will be determined by two independent researchers.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* being diagnosed with fibromyalgia syndrome according to the criteria of the American Rheumatology Association ,
* not receiving active treatment related to physiotherapy,
* volunteering to participate in the study

Exclusion Criteria

* diagnosed endocrine, neuromuscular, infectious and inflammatory diseases,
* severe mental and psychological disorders, using psychological drugs (SSRIs and SNRIs)
* illiterate
* problems with hearing and vision
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kutahya Health Sciences University

OTHER

Sponsor Role lead

Responsible Party

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Ismail Saracoglu

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ismail Saracoglu, P.hD.

Role: PRINCIPAL_INVESTIGATOR

Kutahya Health Sciences University

Locations

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Pamukkale University Hospitals

Denizli, Denizli, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ismail Saracoglu, P.hD.

Role: CONTACT

+905058414662

Esra AKIN, Msc.

Role: CONTACT

05346984874

Facility Contacts

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Bilge Basak CALIK, Prof. Dr.

Role: primary

+90 258 296 60 00

Esra AKIN, Msc.

Role: backup

Ismail SARACOGLU, P.hD.

Role: backup

Bilge Basakci CALIK, Prof. Dr.

Role: backup

Other Identifiers

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painclassificationFMS

Identifier Type: -

Identifier Source: org_study_id

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