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NCT Number: NCT07773766

Prevalence of Fibromyalgia in Patients With Plaque Psoriasis

This observational study aims to determine how common fibromyalgia syndrome and central sensitization are in adults with plaque psoriasis compared to healthy individuals. Plaque psoriasis is a chronic inflammatory skin disease that can affect the entire body, which may increase the risk of developing chronic pain conditions. Fibromyalgia causes widespread musculoskeletal pain, fatigue, and sleep disturbances, while central sensitization involves the central nervous system becoming highly sensitive to pain.

Researchers will evaluate 55 adult patients diagnosed with plaque psoriasis and 55 age- and sex-matched healthy volunteers at the Dermatology Outpatient Clinic at Assiut University Hospital. Participants will undergo a clinical examination to assess their psoriasis severity and will complete standardized questionnaires to evaluate pain intensity, fibromyalgia symptoms, central sensitization, and overall quality of life. The findings of this study may help doctors better understand these overlapping conditions to improve the early identification and management of pain in patients with psoriasis.

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Key information

Who can participate

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

Inclusion criteria

  • Adult patients (≥18 years) with clinically diagnosed plaque psoriasis.
  • Both males and females.
  • Willing to participate and provide written informed consent.
  • For controls: Apparently healthy age- and sex-matched volunteers.
  • For controls: No history of psoriasis, psoriatic arthritis, or other chronic inflammatory or rheumatic diseases.
  • For controls: Willing to participate and provide written informed consent.

Exclusion criteria

  • Patients with psoriatic arthritis or other inflammatory arthritis.
  • Patients with other diagnosed rheumatic diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis).
  • Patients with previously diagnosed major depressive disorder or generalized anxiety disorder.
  • Patients with uncontrolled diabetes mellitus, heart failure, renal failure, or thyroid disorders.
  • Current use of antidepressants, anticonvulsants, or benzodiazepines.
  • History of malignancy.
  • Pregnancy.

Treatment and study plan

Primary outcomes

  1. Percentage of Participants Diagnosed With Fibromyalgia Syndrome

    Time frame: Baseline

    Fibromyalgia will be diagnosed according to the 2016 American College of Rheumatology (ACR) Diagnostic Criteria. This assessment combines two measures: the Widespread Pain Index (WPI), which assesses pain in 19 body regions with scores ranging from 0 to 19, and the Symptom Severity Scale (SSS), which evaluates fatigue, waking unrefreshed, cognitive symptoms, and other somatic symptoms with scores ranging from 0 to 12. For both scales, higher scores indicate worse symptom severity. The combined scores are used to establish a diagnosis of fibromyalgia.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Fibromyalgia in Patients With Plaque Psoriasis - Assiut University Hospital

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 19, 2026
Registry last updated
Aug 19, 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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