NCT07773766

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
12mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Sep 2026Oct 2027

First Submitted

Initial submission to the registry

August 14, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

August 19, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 14, 2026

Last Update Submit

August 14, 2026

Conditions

Keywords

Plaque PsoriasisFibromyalgiaCentral SensitizationQuality of LifeChronic Pain

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Diagnosed With Fibromyalgia Syndrome

    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.

    Baseline

Study Arms (2)

Patients with Plaque Psoriasis

Adult male and female patients (18 years of age and older) who have been clinically diagnosed with plaque psoriasis.

Healthy Controls

Apparently healthy, age- and sex-matched volunteers with no history of psoriasis, psoriatic arthritis, or other chronic inflammatory or rheumatic diseases.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of adult male and female patients (18 years of age and older) clinically diagnosed with plaque psoriasis who are attending the Dermatology Outpatient Clinic at Assiut University Hospital. It also includes a control group of apparently healthy, age- and sex-matched volunteers.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

FibromyalgiaChronic Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Family Medicine

Study Record Dates

First Submitted

August 14, 2026

First Posted

August 19, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

August 19, 2026

Record last verified: 2026-08