Daily Symptom Fluctuations and Functional Impact in Fibromyalgia
ConditionFibromyalgia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorMardin Artuklu University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Active inflammatory rheumatic disease
Major neurological disease
Major change in fibromyalgia treatment within the previous three months
Pregnancy, postpartum period, or breastfeeding
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 1 trial groupGroup A: Adults With Fibromyalgia
Trial outcomes
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.
Time frame
At the initial visitSecondary outcomes
1
Within-Person Association Between Pain and Fatigue
Participants will rate pain and fatigue every morning and evening for seven days using 0-10 numerical rating scales. The within-person correlation between paired pain and fatigue ratings will be calculated for each participant. The relationship between this correlation and the FIQ total score will be examined.
Time frame
During the 7-day monitoring period2
Maximum Pain and Fatigue Levels
The highest pain rating and the highest fatigue rating reported by each participant during the seven-day monitoring period will be identified separately. Both are measured on scales from 0 to 10, with higher scores indicating greater symptom severity. Their relationships with the FIQ total score will be examined.
Time frame
During the 7-day monitoring period3
Perceived Symptom Control
Participants will rate their perceived control over their symptoms once daily for seven days using a scale from 0 to 10. The relationship between perceived symptom control and the FIQ total score will be examined.
Time frame
During the 7-day monitoring period4
Sleep Quality
Participants will rate the quality of the previous night's sleep each morning for seven days using a scale from 0 to 10. The relationships of sleep quality with pain, fatigue, and the FIQ total score will be examined.
Time frame
During the 7-day monitoring periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov