Quantitative Ultrasound of the Enthesis in Fibromyalgia and Psoriatic Arthritis

NCT05447741 | Terminated

• 1 other identifier: CE 21.405
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia; Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• Shear wave speed (SWS) (in m/sec).

  Area under the ROC curve of the SWS to discriminate between groups.

  Shear Wave Speed will be acquired when patients will be included in the study, from June 2022 to December 2023.

Secondary Outcomes (4)

• The quantitative ultrasound marker 'μ'.

  The mean intensity μ will be acquired when patients will be included in the study, from June 2022 to December 2023.

• The quantitative ultrasound marker '1/alpha'.

  the acoustic inhomogeneity 1/alpha parameter will be acquired when patients will be included in the study, from June 2022 to December 2023.

• The quantitative ultrasound marker 'κ'.

  The structure parameter κ will be acquired when patients will be included in the study, from June 2022 to December 2023.

• Inter-rater reliability

  Shear Wave Elastography and RF data acquisitions that will be used for the inter-operator reliability measurements will be conducted when patients will be included in the study, from June 2022 to December 2023

Study Arms (3)

Patients with fibromyalgia

Participants will have a quantitative ultrasound examination of the dominant Achilles' tendon, medial collateral ligament at the femoral epicondyle and common extensor tendon at the lateral epicondyle of the elbow.

Diagnostic Test: Quantitative Ultrasound

Patients with psoriasis arthritis

Participants will have a quantitative ultrasound examination of the dominant Achilles' tendon, medial collateral ligament at the femoral epicondyle and common extensor tendon at the lateral epicondyle of the elbow.

Diagnostic Test: Quantitative Ultrasound

Asymptomatic controls

Participants will have a quantitative ultrasound examination of the dominant Achilles' tendon, medial collateral ligament at the femoral epicondyle and common extensor tendon at the lateral epicondyle of the elbow.

Diagnostic Test: Quantitative Ultrasound

Interventions

Quantitative Ultrasound DIAGNOSTIC_TEST

Shear Wave Elastography acquisition. RF data acquisition (for HDK parameters calculation).

Asymptomatic controls; Patients with fibromyalgia; Patients with psoriasis arthritis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with fibromyalgia will be recruited through various outreach approaches such as local newspapers, digital advertising on the Centre hospitalier de l'Université de Montréal (CHUM) platforms, and the collaboration of healthcare providers. Subjects with psoriatic arthritis will be recruited from those patients attending the rheumatology clinics at the CHUM. Asymptomatic volunteers will be recruited from the hospital community through local advertisements.

You may qualify if:

• 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.

You may not qualify if:

• Pregnant and breast-feeding women
• History of spinal surgery or surgery to the extremities.
• Previous severe back or extremity fracture.
• Spinal or joint corticosteroid injections in the past 3 months.
• 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 unable to answer questionnaires in French or English.
• Subjects with psychiatric disorders that affect communication.
• Subjects who refused to participate.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0C1, Canada

Location

MeSH Terms

Conditions

Fibromyalgia; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nathalie J Bureau, MD MSc

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: July 7, 2022
• Study Start: October 1, 2022
• Primary Completion: February 12, 2025
• Study Completion: February 12, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

CA (1)