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Enrolling by Invitation

NCT Number: NCT07662993

Factors Associated With Cognitive Skills in Patients With Fibromyalgia

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

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Pamukkale University

Denizli, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Dynamic Loewenstein Occupational Therapy Cognitive Assessment (DLOTCA)

    Time frame: 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 outcomes

  1. Fibromyalgia Impact Questionnaire

    Time frame: At 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.

  2. Pressure Pain Threshold Measurements

    Time frame: At 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.

  3. Cognitive Exercise Therapy Approach Scale

    Time frame: At 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.

  4. Tampa Kinesiophobia Scale

    Time frame: At 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.

  5. Pain Catastrophizing Scale:

    Time frame: 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.

  6. The Short Pain Inventory

    Time frame: At 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.

  7. Generalized Pain Index and Symptom Severity Scale

    Time frame: At 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.

Sponsors and collaborators

Lead sponsor

Zülal TATAR

Other

Registry information

Official study title

Identifying Factors Associated With Cognitive Skills in Female Patients With Fibromyalgia

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 23, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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