NCT05447741Terminated
Quantitative Ultrasound of the Enthesis in Fibromyalgia and Psoriatic Arthritis
Fibromyalgia Versus Psoriatic Arthritis: Is Quantitative Ultrasound of the Enthesis a New Marker of Disease?
Source: ClinicalTrials.gov · Last updated 25 Feb 2025
Reason given: The recruitment and examination of participants were halted prematurely due to depleted funds.
Brief summary (registry, in English)
This prospective, cross-sectional, observational study will include subjects with fibromyalgia (FM), psoriatic arthritis (PsA) and asymptomatic controls. Participants will undergo a research ultrasound (US) exam of the enthesis of the Achilles' tendon, the medial collateral ligament at the femoral epicondyle and the common extensor tendon at lateral epicondyle of the elbow in resting conditions. The research US exam will consist of shear wave elastography (SWE) and radiofrequency (RF) data acquisitions. SWE technology will allow quantification of the shear wave speed (SWS) reporting the elastic stiffness of the tissues under investigation. RF data will be used to estimate quantitative ultrasound (QUS) parameters characterizing the mean intensity μ (akin to B-mode echogenicity), acoustic inhomogeneity (1/alpha), and structural spatial organization of echoes (κ) in the tissue.
- Status (registry)
- Terminated
- Study type
- Observational
- Enrollment
- 81 (actual)
- First submitted
- 8 Jun 2022
- Start date
- 1 Oct 2022
- Primary completion date
- 12 Feb 2025
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Diseases
- Psoriasis, Psoriatic arthritis
- NCT number
- NCT05447741
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous severe back or extremity fracture.
- Spinal or joint corticosteroid injections in the past 3 months.
Other illness
- History of spinal surgery or surgery to the extremities.
- Major chronic illness (e.g., active cancer, inflammatory rheumatic disease other than psoriatic arthritis, or other chronic uncontrolled condition such as neurological, kidney, liver, cardiac, respiratory, or endocrine disease).
- Subjects with psychiatric disorders that affect communication.
Other
- Pregnant and breast-feeding women
- Subjects unable to answer questionnaires in French or English.
- Subjects who refused to participate.
Who the study is looking for
- Subjects with fibromyalgia:
- The diagnosis of fibromyalgia is based on the 2011 ACR criteria and confirmed by a pain medicine physician working at a tertiary care academic center (CHUM) having experience with patients with fibromyalgia and other chronic pain syndromes.
- Fibromyalgia is the primary reason for the patient's symptoms, without any other comorbid condition that could fully account for the symptoms of pain.
- No skin condition (psoriasis, eczema and others) requiring regular topical treatment.
- Subjects with psoriatic arthritis:
- Presenting with psoriatic arthritis
- The diagnosis of psoriatic arthritis will be based on the ClASsification for Psoriatic Arthritis (CASPAR) criteria and established by a rheumatologist working at a tertiary care academic center (CHUM).
- No comorbid fibromyalgia as determined by the rheumatologist.
- Asymptomatic subjects:
- No history of chronic pain syndromes, malformations, injuries, infections or tumors limiting activities of daily living and work.
- Not engaged in professional sports.
- No skin condition (psoriasis, eczema and others) requiring regular topical treatment.
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier de l'Université de Montréal | Montreal | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.