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临床试验/NCT05762679
NCT05762679已完成不适用

Developing Quantitative Imaging and Other Relevant Biomarkers of Myofascial Tissues for Clinical Pain Management

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2023年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
1
主要终点
T1 Rho MRI Relaxation Time of Shoulder External Rotator (Milliseconds)

研究概览

简要总结

The purpose of this study is to quantify the extent of GlycosAminoGlycan/Hyaluronic Acid (GAG/HA) accumulation using T1rho (T1ρ) MRI in the paretic versus non-paretic shoulder rotator muscles, and correlate the T1ρ Magnetic Resonance Imaging (MRI) measurements with US echo texture measurements to develop a clinic-friendly tool to infer the extent of HA accumulation; and to distinguish between latent versus active Post Stroke Shoulder Pain (PSSP) using ultrasound (US) shear strain mapping of the same muscles on the paretic side compared with the non-paretic side.

详细描述

Shoulder pain is extremely common after stroke and occurs in 30-70% of patients. Chronic post stroke shoulder pain (PSSP) contributes to depression, interferes with motor recovery, and decreases quality of life. Although PSSP is thought to be caused by damage to the myofascial tissues around the shoulder joint, the pathophysiology of myofascial dysfunction and pain in PSSP has not been elucidated, leading to missed opportunities for early diagnosis, and variable success with pain management. The accumulation of HA in muscle and its fascia can cause myofascial dysfunction. HA is a GAG and a chief constituent of the extracellular matrix of muscle. In physiologic quantities, it functions as a lubricant and a viscoelastic shock absorber, enabling force transmission during muscle contraction and stretch. Reduced joint mobility and spasticity can result in focal accumulation and alteration of HA in muscle, leading to the development of taut bands, dysfunctional gliding of deep fascia and muscle layers, Reduced Range of Motion (ROM), and pain. Muscle HA concentrations can be imaged using T1ρ MRI, and myofascial dysfunction can be assessed using echo texture analysis and shear strain mapping on quantitative US, which may serve as useful biomarkers to elucidate the pathophysiology of myofascial dysfunction in PSSP.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years or older
  • Hemiparesis from Ischemic or Hemorrhagic Stroke
  • 4-120 months post-stroke with Hemiparesis since the incidence and intensity of PSSP
  • Show a difference of more than 10 degrees of passive ER-ROM between non-paretic and paretic shoulders with or without pain
  • Able to provide informed consent and comply with testing protocols

排除标准

  • Received treatment for spasticity with Botulinum Toxin or Intrathecal Baclofen within the past three months
  • Have another neurologic condition that may affect motor response (e.g. Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS))
  • Have a contraindication to MRI (claustrophobia, magnetic pacemakers and clips)
  • Have non-musculoskeletal PSSP such as only central pain or Chronic Regional Pain Syndrome (CRPS)
  • Have a complicated medical condition, or significant injury to either upper limb.

结局指标

主要结局

T1 Rho MRI Relaxation Time of Shoulder External Rotator (Milliseconds)

时间窗: Baseline

Comparison of T1rho (T1ρ) MRI relaxation time of infraspinatus muscles on the paretic and non-paretic sides of patients with post stroke shoulder pain.

T1 Rho MRI Relaxation Time of Shoulder Internal Rotator (Milliseconds)

时间窗: Baseline

Comparison of T1rho (T1ρ) MRI relaxation time of pectoralis major muscles on paretic and non-paretic shoulders in patients with post stroke shoulder pain.

Ultrasound Shear Strain Percentage Between Paretic vs. Non-paretic Muscles

时间窗: Baseline

Comparison of ultrasound shear strain between pectoralis major and pectoralis minor muscles on the paretic and non-paretic sides in patients with post stroke shoulder pain.

Ultrasound Shear Strain Percentage Between Paretic vs. Non-paretic Side in Patients With High Severity Post Stroke Shoulder Pain

时间窗: Baseline

Comparison of ultrasound shear strain between pectoralis major and minor muscles on the paretic side compared with the non-paretic side in patients with high severity post stroke shoulder pain

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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