Quantitative Ultrasound of the Enthesis in Fibromyalgia and Psoriatic Arthritis

NCT ID: NCT05447741

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 81 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2025-02-12

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.

Detailed Description

In this prospective, cross-sectional, observational study consecutive eligible subjects with FM, PsA, and a group of age- and sex-matched asymptomatic volunteers will undergo a research US examination of the dominant Achilles' tendon, knee medial collateral ligament and common extensor tendon of the elbow. Two operators under the supervision of a musculoskeletal radiologist will perform the US exam. B-mode and Power Doppler ultrasound of each tendon and ligament will be performed for morphological characterization. Then, shear wave elastography (SWE) and radiofrequency (RF) will be acquired. The shear wave speed (SWS) will be measured in the longitudinal plane using shear wave measurements. These features will be compared between groups. The HDK parameters (μ, 1/alpha, κ) will be computed offline, using RF sequences recorded in the longitudinal plane. Demographic features (participant age, sex, body mass index), the Leeds Enthesis Index (LEI) score assessed by the referring clinicians, and the self-administered Health Assessment Questionnaire (HAQ), Brief Pain Inventory (PBI) and Fibromyalgia Impact Questionnaire (FIQ) scores will be available for multivariate analyses.

Conditions

Fibromyalgia; Psoriatic Arthritis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Quantitative Ultrasound

Intervention Type: DIAGNOSTIC_TEST

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

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.

Quantitative Ultrasound

Intervention Type: DIAGNOSTIC_TEST

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

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.

Quantitative Ultrasound

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Quantitative Ultrasound

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathalie J Bureau, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

CE 21.405

Identifier Type: -

Identifier Source: org_study_id