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 range

18 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years

Sex

ALL

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