CompletedNot Applicable

Quantifying Myofascial Dysfunction in Post-Stroke Pain

United States46 participantsStarted 2023-02-28

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline

Trial details

NCT IDNCT05762679

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-24

Results submitted2025-05-22

View on ClinicalTrials.gov More Myofascial Dysfunction trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline