Quantifying Myofascial Dysfunction in Post-Stroke Pain (Myofascial)

June 24, 2025 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University School Of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

We will enroll 20 patients each with latent PSSP and active PSSP group, repectively.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paretic

Subgroups:

Low severity PSSP - defined as focal palpable nodules that may be tender on palpation with pain rating of < 5/10 when combined with the hand-behind-neck (HBN) maneuver.

High severity PSSP - defined as focal palpable nodules that are tender on palpation, reproducing the pain, and eliciting a pain rating of >= 5/10 when combined with the hand-behind-neck (HBN) maneuver.
Diagnostic test: Imaging
Phase 1 is an imaging biomarker study.
Other: Non-Paretic
The non-paretic side of the same patients serves as the control.
Diagnostic test: Imaging
Phase 1 is an imaging biomarker study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline
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.
Baseline
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

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

Investigators

  • Principal Investigator: Preeti Raghavan, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2023

Primary Completion (Actual)

May 24, 2024

Study Completion (Actual)

May 24, 2024

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 10, 2023

Study Record Updates

Last Update Posted (Actual)

July 9, 2025

Last Update Submitted That Met QC Criteria

June 24, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00354876
  • 1R61AT012279-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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