NCT05762679

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

February 28, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 9, 2025

Completed
Last Updated

July 9, 2025

Status Verified

June 1, 2025

Enrollment Period

1.2 years

First QC Date

February 28, 2023

Results QC Date

May 22, 2025

Last Update Submit

June 24, 2025

Conditions

Myofascial Dysfunction

Keywords

GlycosaminoglycanHyaluronic acidPost stroke shoulder pain

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Paretic

EXPERIMENTAL

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

Non-Paretic

OTHER

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

Diagnostic Test: Imaging

Interventions

ImagingDIAGNOSTIC_TEST

Phase 1 is an imaging biomarker study.

Non-PareticParetic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Hemiparesis from Ischemic or Hemorrhagic Stroke
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Interventions

Diagnostic Imaging

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Results Point of Contact

Title
Dr. Preeti Raghavan
Organization
Johns Hopkins school of medicine
praghavan@jhmi.edu
9174889626

Study Officials

  • Preeti Raghavan, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 10, 2023

Study Start

February 28, 2023

Primary Completion

May 24, 2024

Study Completion

May 24, 2024

Last Updated

July 9, 2025

Results First Posted

July 9, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)