Quantifying Myofascial Dysfunction in Post-Stroke Pain

NCT ID: NCT05762679

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2024-05-24

Brief 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.

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.

Conditions

Myofascial Dysfunction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Imaging

Intervention Type: DIAGNOSTIC_TEST

Phase 1 is an imaging biomarker study.

Non-Paretic

The non-paretic side of the same patients serves as the control.

Group Type: OTHER

Imaging

Intervention Type: DIAGNOSTIC_TEST

Phase 1 is an imaging biomarker study.

Interventions

Imaging

Phase 1 is an imaging biomarker study.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

New York University

OTHER

Sponsor Role: collaborator

George Mason University

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Preeti Raghavan, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R61AT012279-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00354876

Identifier Type: -

Identifier Source: org_study_id