Fibromyalgia Versus Psoriatic Arthritis: Is Quantitative Ultrasound of the Enthesis a New Marker of Disease?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Shear wave speed (SWS) (in m/sec).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Shear wave speed (SWS) (in m/sec).
时间窗: 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.
次要结局
- 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 '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 '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)