Skip to content

Factors Associated With Cognitive Skills in Patients With Fibromyalgia

Identifying Factors Associated With Cognitive Skills in Female Patients With Fibromyalgia

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07662993
Enrollment
41
Registered
2026-06-23
Start date
2026-05-12
Completion date
2027-09-12
Last updated
2026-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognition, Fibromyalgia

Brief summary

The aim of this study was to identify factors associated with cognitive skills in female patients with fibromyalgia.

Interventions

None listed

Sponsors

Zülal TATAR
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years

Inclusion criteria

* Being between 18-65 years of age * Being female * Having been diagnosed with fibromyalgia for at least 6 months, with the appearance of a range of somatic and cognitive symptoms in addition to widespread pain.

Exclusion criteria

* Having another illness that affects their physical condition * Having cognitive impairment to the extent that they cannot cooperate * Being pregnant * Impaired Turkish language comprehension or speech * Concurrent autoimmune or inflammatory disease * Diseases affecting the central nervous system (e.g., multiple sclerosis, Parkinson's disease) * Serious psychiatric conditions that prevent participation (e.g., psychotic disorders).

Design outcomes

Primary

MeasureTime frameDescription
Dynamic Loewenstein Occupational Therapy Cognitive Assessment (DLOTCA)At baseline (Day 1)DLOTCA assesses the basic cognitive skills of individuals aged 18-69 years using 28 subtests across 7 cognitive domains (Awareness, Orientation, Spatial Perception, Visual Perception, Visual-Motor Structuring, Application, and Thinking Processes) (13). Each subtest has 3 scoring stages: First stage: Pre-mediation scoring (1 point indicates the worst performance). Second stage: Mediation score (a high score (4 or 5) indicates poor performance). Third stage: Post-mediation scoring (1 point indicates the worst performance).

Secondary

MeasureTime frameDescription
Fibromyalgia Impact QuestionnaireAt Baseline (Day 1)This physical impact scale, administered to patients, was developed by Burchardt et al. to measure functional status in fibromyalgia patients. The scale primarily measures 10 separate characteristics: physical function, well-being, inability to work, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety, and depression. Except for well-being, lower scores indicate improvement or less severe impact from the disease. Each subcategory can have a maximum score of 10, resulting in a total maximum score of 100.
Pressure Pain Threshold MeasurementsAt baseline (Day 1)Pressure pain threshold measurements will be assessed using a pressure algometer, a gun-shaped apparatus with a 1-cm² rigid rubber probe held at a 90-degree angle to the body and then applying pressure at a constant rate of increasing pressure (30 kPa/s) until the patient's pain threshold is reached. The assessment will be performed bilaterally in 4 different regions, one assessment per anatomical region: trapezius muscle, elbows (lateral epicondyle), quadriceps femoris muscle, and knees (in the medial fat pad near the joint line). For each participant, the total mean pressure pain threshold measurements will be calculated and used for analysis. Sensitive points will be determined according to the guidelines of Okifuji et al. Previous studies have shown that assessing pressure pain threshold measurements in a limited number of regions provides a good estimate of overall sensitivity.
Cognitive Exercise Therapy Approach ScaleAt baseline (Day 1)The Cognitive Exercise Therapy Approach Scale assesses the biopsychosocial status of patients with rheumatic diseases. The total score ranges from 0 to 120. Higher scores indicate a worse biopsychosocial status.
Tampa Kinesiophobia ScaleAt Baseline (Day 1)The original Tampa Kinesiophobia Scale was developed by Miller, Kopri and Todd in 1991, but was not published. Vlaeyen et al. republished the original scale, consisting of 17 questions, in 1995, with the permission of the researchers who developed it. TAS is a 17-question scale developed to measure fear of movement/re-injury. The scale includes injury/re-injury and fear-avoidance parameters in work-related activities.
Pain Catastrophizing Scale:At baseline (Day 1)Developed to identify patients' catastrophic thoughts or feelings about the pain they experience and their ineffective coping strategies, this scale is a thirteen-item Likert-type self-assessment scale. Each item is scored between 0 and 4. The total score ranges from 0 to 52. Higher scores indicate a high level of catastrophizing.
The Short Pain InventoryAt baseline (Day 1)The Short Pain Inventory is a short, easy-to-administer assessment method that can be used to evaluate pain. It includes numerical rating scales from 0 to 10. In the Short Pain Inventory, the worst pain is defined as mild (1-4), moderate (5-6), and severe (7-10). It assesses the severity of pain, its localization, medical treatments for pain, and its impact on daily functions, and asks how much pain has decreased in the last 24 hours or the past week. Answering all questions takes a short time, approximately 5-10 minutes.
Generalized Pain Index and Symptom Severity ScaleAt baseline (Day 1)The Generalized Pain Index is an index that assesses a patient's pain in 19 regions over the past week. The Symptom Severity Scale consists of 3 questions: fatigue, difficulty thinking and remembering, and sleeplessness. The severity of each of these 3 complaints over the past week is scored using a scale from 0: no problem, 1: mild problem, 2: moderate problem, 3: severe problem.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 24, 2026