Functional Capacity Determinants in Fibromyalgia

NCT ID: NCT07318441

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-15
• Study Completion Date: 2025-12-15

Brief Summary

Fibromyalgia is a chronic pain disorder characterized by widespread pain and multiple systemic symptoms that negatively affect functional capacity. Although common symptoms and clinical features of fibromyalgia have been well described, the factors influencing functional capacity remain unclear. Therefore, this study aims to identify the determinants of functional capacity in patients with fibromyalgia.

Detailed Description

Fibromyalgia is a chronic pain disorder characterized by widespread pain, fatigue, sleep disturbances, cognitive problems, and mood disorders, affecting 5% of the population, predominantly women. This condition lacks objective diagnostic markers and relies on subjective symptoms and tender points for diagnosis. The etiology of fibromyalgia, which involves biological, genetic, and environmental factors, remains unclear, making diagnosis difficult due to symptom variability and comorbidities. Pathophysiological mechanisms are not fully understood, leading to difficulties in diagnosis and treatment. Historically, fibromyalgia has evolved from terms such as 'neurasthenia' to 'fibrositis', and understanding has shifted from muscle inflammation to central nervous system dysfunction. The American College of Rheumatology criteria play a crucial role in diagnosing fibromyalgia, helping to reduce patient anxiety and unnecessary testing. In the literature, pain, fatigue, sleep problems, and trigger point sensitivity are among the symptoms frequently seen in fibromyalgia patients. Studies conducted on these symptoms indicate that patients particularly experience anxiety, depression, decreased functional capacity, decreased functional mobility, postural abnormalities, decreased respiratory and peripheral muscle strength, decreased physical activity, and difficulties in daily living activities.

Although surveys conducted with fibromyalgia patients have identified symptoms, no studies have been found that examine the factors affecting functional capacity. Therefore, the aim of this study is to determine the factors affecting functional capacity in patients with fibromyalgia.

Conditions

Fibromyalgia; Fatigue

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Fibromyalgia Group

Patients diagnosed with fibromyalgia who attend the Physical Medicine and Rehabilitation Outpatient Clinic will undergo comprehensive assessments of functional capacity, pain, fatigue, mobility, muscle strength, posture, psychosocial factors, physical activity level, circadian rhythm, and sleep quality. No intervention will be applied.

Group Type: OTHER

Assessment Only

Intervention Type: OTHER

No therapeutic intervention will be applied. Participants will undergo standardized clinical, functional, and self-reported assessments, including functional capacity tests, pain and fatigue evaluation, mobility and muscle strength assessments, posture analysis, psychosocial questionnaires, physical activity level, circadian rhythm, and sleep quality evaluation

Interventions

Assessment Only

No therapeutic intervention will be applied. Participants will undergo standardized clinical, functional, and self-reported assessments, including functional capacity tests, pain and fatigue evaluation, mobility and muscle strength assessments, posture analysis, psychosocial questionnaires, physical activity level, circadian rhythm, and sleep quality evaluation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Individuals diagnosed with fibromyalgia according to the American College of Rheumatology criteria
• Be 18 years of age or older
• Be a volunteer
• Be able to read and write

Exclusion Criteria

• Having a condition that prevents communication,
• Having undergone surgery within the last 6 months
• Being an elite athlete
• Having an active infection
• Having a neurological or orthopedic problem that prevents movement
• Being a cancer patient

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Izmir Democracy University

OTHER

Sponsor Role: lead

Responsible Party

Betül Taşpınar

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Beyzanur Beğenen Şavlı, Msc.Pt.

Role: PRINCIPAL_INVESTIGATOR

Izmir Democracy University

Betül Taspinar, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Izmir Democracy University

Ferruh Taspinar, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Izmir Democracy University

Locations

Betül TAŞPINAR

Konak, İ̇zmi̇r, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

FMS-35

Identifier Type: -

Identifier Source: org_study_id