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The recruitment and examination of participants were halted prematurely due to depleted funds.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantitative Ultrasound | Diagnostic Test | Shear Wave Elastography acquisition. RF data acquisition (for HDK parameters calculation). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The quantitative ultrasound marker 'μ'. | 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 mean intensity μ will be acquired when patients will be included in the study, from June 2022 to December 2023. |
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Inclusion Criteria Male and female subjects of all races and ethnic backgrounds aged between 18 - 60 years, able to provide informed consent and willing not to engage in sports activities for two days before the ultrasound (US) evaluation, will be considered eligible for this study.
Subjects with fibromyalgia:
Subjects with psoriatic arthritis:
Asymptomatic subjects:
Exclusion Criteria
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Nathalie J Bureau, MD MSc | Centre hospitalier de l'Université de Montréal (CHUM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier de l'Université de Montréal | Montreal | Quebec | H2X 0C1 | Canada |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| The quantitative ultrasound marker '1/alpha'. |
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 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'. | 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. | The structure parameter κ will be acquired when patients will be included in the study, from June 2022 to December 2023. |
| Inter-rater reliability | 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). | 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 |
| D009422 |
| Nervous System Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |