Plaque PsoriasisNCT07773766
Prevalence of Fibromyalgia in Patients With Plaque Psoriasis
An observational study of Plaque Psoriasis and Fibromyalgia, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis, Fibromyalgia
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Fibromyalgia in Patients With Plaque Psoriasis - Assiut University Hospital
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.
- Conditions
- Plaque Psoriasis, Fibromyalgia
- Keywords
- Plaque Psoriasis, Fibromyalgia, Central Sensitization, Quality of Life, Chronic Pain
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Salah Eldin Hassan Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773766
- Sponsor's protocol ID
- Fibromyalgia in Psoriasis
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibromyalgia in Patients With Plaque Psoriasis - Assiut University Hospital
- ClinicalTrials.gov ID
- NCT07773766
- Acronym / sponsor ID
- Fibromyalgia in Psoriasis
- Conditions
- Plaque Psoriasis, Fibromyalgia
- Keywords
- Plaque Psoriasis, Fibromyalgia, Central Sensitization, Quality of Life, Chronic Pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Plaque Psoriasis and Fibromyalgia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Diagnosed With Fibromyalgia Syndrome (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.