Quantitative Ultrasound of the Enthesis in Fibromyalgia and Psoriatic Arthritis

Terminated

• Conditions: Fibromyalgia; Psoriatic Arthritis
• Interventions: Diagnostic Test: Quantitative Ultrasound

• Registration Number: NCT05447741
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Study Timeline

• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-07-02
• Study First Posted: 2022-07-07
• Study Start: 2022-10-01
• Status Verified: 2025-02
• Primary Completion: 2025-02-12
• Study Completion: 2025-02-12
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with psoriasis arthritis	Quantitative Ultrasound	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.
Asymptomatic controls	Quantitative Ultrasound	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.
Patients with fibromyalgia	Quantitative Ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Shear wave speed (SWS) (in m/sec).	Shear Wave Speed will be acquired when patients will be included in the study, from June 2022 to December 2023.	Area under the ROC curve of the SWS to discriminate between groups.

Secondary Outcome Measures

Name	Time	Method
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.	Statistical analysis of the echo envelope: the acoustic inhomogeneity 1/alpha parameter. This marker is unitless.; Area under the ROC curve of the 1/alpha parameter to discriminate between groups.
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.	Statistical analysis of the echo envelope: the mean intensity μ. This marker is unitless.; Area under the ROC curve of the μ parameter to discriminate between groups.
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.	Statistical analysis of the echo envelope: the structure parameter κ. This marker is unitless.; Area under the ROC curve of the κ parameter to discriminate between groups.
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	Estimation of the inter-operator reliability of the ultrasound parameter measurements on each enthesis.; The inter-operator reliability will be assessed in terms of intraclass correlation coefficient (ICC 2,1) and coefficient of variation (CV).

Trial Locations

Locations (1)

Centre hospitalier de l'Université de Montréal; 🇨🇦 Montréal, Quebec, Canada