Daily Symptom Fluctuations and Functional Impact in Fibromyalgia

NCT07826520 | Recruiting

• 1 other identifier: MTRH-PMR-TYY3
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Fibromyalgia is a chronic condition that commonly causes widespread pain, fatigue, and difficulty in daily activities. These symptoms may change from day to day, even when their average severity is similar. This study aims to examine whether daily changes in pain and fatigue are related to functional impact in adults with fibromyalgia. Participants will complete clinical questionnaires at the first visit and record their pain and fatigue levels for seven days. Sleep quality and perceived control over symptoms will also be recorded. No treatment or additional medical procedure will be given as part of the study.

Conditions

Fibromyalgia

Keywords

Symptom Fluctuation; Fibromyalgia Impact Questionnaire; Central Sensitization; Sleep Quality; Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Functional Impact Assessed by the Fibromyalgia Impact Questionnaire

  Functional impact will be assessed using the Fibromyalgia Impact Questionnaire (FIQ). The total score ranges from 0 to 100, with higher scores indicating greater impact of fibromyalgia. The main analysis will examine whether within-person variability in pain and fatigue over seven days is associated with the FIQ score independently of average pain and fatigue levels.

  At the initial visit

Secondary Outcomes (4)

• Within-Person Association Between Pain and Fatigue

  During the 7-day monitoring period

• Maximum Pain and Fatigue Levels

  During the 7-day monitoring period

• Perceived Symptom Control

  During the 7-day monitoring period

• Sleep Quality

  During the 7-day monitoring period

Study Arms (1)

Adults With Fibromyalgia

Adults aged 18-65 years who meet the 2016 American College of Rheumatology criteria for fibromyalgia will be included. Participants will complete clinical questionnaires at the initial visit and record pain and fatigue levels for seven days. Sleep quality and perceived symptom control will also be recorded. No treatment or experimental intervention will be administered as part of the study.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adults aged 18-65 years who attend the Physical Medicine and Rehabilitation outpatient clinic of Mardin Training and Research Hospital and meet the 2016 American College of Rheumatology criteria for fibromyalgia. Both female and male participants will be included. All participants must be able to complete the seven-day symptom records and provide written informed consent. No healthy control group will be included.

You may qualify if:

• Diagnosis of fibromyalgia according to the 2016 American College of Rheumatology criteria
• Age between 18 and 65 years
• Ability to understand and complete the daily symptom records
• Ability and willingness to provide written informed consent

You may not qualify if:

• Active inflammatory rheumatic disease
• Major neurological disease
• Major change in fibromyalgia treatment within the previous three months
• Pregnancy, postpartum period, or breastfeeding
• Cognitive impairment or inability to provide informed consent
• Completion of less than 70% of the required daily symptom records
• Major change in fibromyalgia treatment during the seven-day monitoring period

Sponsors & Collaborators

• Mardin Artuklu University: lead

Study Sites (1)

Mardin Training and Research Hospital

Mardin, 47100, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Bartley EJ, Robinson ME, Staud R. Pain and Fatigue Variability Patterns Distinguish Subgroups of Fibromyalgia Patients. J Pain. 2018 Apr;19(4):372-381. doi: 10.1016/j.jpain.2017.11.014. Epub 2017 Dec 15.

  PMID: 29253551 BACKGROUND

• Affleck G, Urrows S, Tennen H, Higgins P, Abeles M. Sequential daily relations of sleep, pain intensity, and attention to pain among women with fibromyalgia. Pain. 1996 Dec;68(2-3):363-8. doi: 10.1016/s0304-3959(96)03226-5.

  PMID: 9121825 BACKGROUND

• Harris RE, Williams DA, McLean SA, Sen A, Hufford M, Gendreau RM, Gracely RH, Clauw DJ. Characterization and consequences of pain variability in individuals with fibromyalgia. Arthritis Rheum. 2005 Nov;52(11):3670-4. doi: 10.1002/art.21407.

  PMID: 16258905 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Central Study Contacts

Taha Yasin YILDIRIM, M.D.

CONTACT

+90 534 220 77 17; tyasinyildirim.ftr@gmail.com

Hatice Gözde Sümer, M.D.

CONTACT

+90 532 157 72 99; gzdsmr@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: September 12, 2026
• First Posted: September 17, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): February 15, 2027
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)