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Completed

NCT Number: NCT05762679

Quantifying Myofascial Dysfunction in Post-Stroke Pain

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.

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Key information

Conditions

Myofascial Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Imaging

Diagnostic Test

Phase 1 is an imaging biomarker study.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • George Mason University
  • National Center for Complementary and Integrative Health (NCCIH)
  • New York University

Registry information

Official study title

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

Acronym: Myofascial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 10, 2023
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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