The Diagnostic Ultrasound Enthesitis Tool (DUET) Study
- Conditions
- Psoriatic ArthritisPsoriasisNon-Inflammatory Rheumatic Conditions
- Interventions
- Diagnostic Test: Musculoskeletal Ultrasound
- Registration Number
- NCT04587362
- Lead Sponsor
- Women's College Hospital
- Brief Summary
Psoriatic arthritis (PsA) is a type of joint disease that can lead to severe joint damage and disability within the first few years of the disease. This is why early detection and treatment of the disease is essential to prevent serious joint damage and improve long-term outcomes in these patients. However, there is currently no reliable way to tell the difference between PsA and other types of joint disease. This makes it difficult to detect PsA early. Enthesitis is an inflammation of the area where muscle tendons and ligaments attach to bones. Enthesitis is a key feature in PsA and can be easily detected using ultrasonography. The aim of this research study is to develop a system to evaluate enthesitis using ultrasonography, which can be used as an effective tool in the early detection of PsA. This will help in providing patients with early treatment to prevent further joint damage.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 419
- Age ≥18
- Able to provide an informed consent
Specific Inclusion Criteria for PsA:
- Meets the CASPAR criteria for PsA
- Early PsA - Less than 5 years from a rheumatologist diagnosis of PsA
Specific Inclusion Criteria for Psoriasis:
- Dermatologist confirmed diagnosis of psoriasis
- No prior diagnosis of PsA or signs of PsA on physical examination
- Psoriasis Epidemiology Screening Tool (PEST) score < 3
Specific Inclusion Criteria for non-inflammatory rheumatic disease:
- Referred to rheumatology for musculoskeletal symptoms such as joint pain, stiffness, back pain
- No evidence of inflammatory rheumatic condition including rheumatoid arthritis, spondyloarthritis, systemic lupus erythematosus, scleroderma, gout, septic arthritis or recent joint trauma/surgery
- No psoriasis
- No inflammatory bowel disease
- Using any biologic medications including Tumor Necrosis Factor (TNF) inhibitors, Interleukin (IL)-17 inhibitors, IL-23 inhibitors, IL-12/23 inhibitors, Janus Kinase (JAK) inhibitors
- Prednisone ≥ 7.5 mg/day
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non-Inflammatory Rheumatic conditions Musculoskeletal Ultrasound Patients with non-inflammatory rheumatic conditions such as osteoarthritis, non-specific back pain, soft tissue rheumatism, degenerative tendinopathy and fibromyalgia. Patients with present or past history of psoriasis, psoriatic arthritis, known or suspected rheumatic inflammatory conditions (e.g. rheumatoid arthritis, spondyloarthritis and gout), and/or inflammatory bowel disease will be excluded. Psoriatic Arthritis Musculoskeletal Ultrasound Subjects newly diagnosed with psoriatic arthritis (\< 5 years), confirmed by a rheumatologist and fulfilling the ClASsification for Psoriatic ARthritis (CASPAR) criteria. Psoriasis without musculoskeletal symptoms Musculoskeletal Ultrasound Patients with dermatologist confirmed psoriasis, without any history of Psoriatic Arthritis, and musculoskeletal symptoms.
- Primary Outcome Measures
Name Time Method DUET scoring system for early diagnosis of PsA From beginning to end of physical & ultrasound assessment, up to 1.5 hours To derive the DUET scoring system for distinguishing PsA from non-inflammatory disease using musculoskeletal ultrasound. The investigators will report the optimal set of weighted parameters and their performance measures (area under the curve, suggested cut-off points, sensitivity, and specificity).
- Secondary Outcome Measures
Name Time Method Assess the construct validity of the new DUET scoring system From beginning to end of physical & ultrasound assessment, up to 1.5 hours Construct validity of the newly derived DUET scoring system will evaluate its correlation with clinical measures of disease activity (e.g. total enthesitis count, joint count) and patient reported outcomes.
The investigators will evaluate the agreement between central and local readers using the new scoring system to evaluate its reliability among local readers using intra-class correlation coefficient.
Trial Locations
- Locations (1)
Women's College Hospital
🇨🇦Toronto, Ontario, Canada