Quantifying Myofascial Dysfunction in Post-Stroke Pain (Myofascial)

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: Myofascial Dysfunction
• Intervention / Treatment: Diagnostic test: Imaging

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	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)	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	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	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

• 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

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: Hyaluronic acid; Glycosaminoglycan; Post stroke shoulder pain
• 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