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N/A N=42 Diagnostic

Quantifying Myofascial Dysfunction in Post-Stroke Pain

Myofascial Dysfunction

Bottom Line

View on ClinicalTrials.gov: NCT05762679 ↗
Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: T1 Rho MRI Relaxation Time of Shoulder External Rotator (Milliseconds) — 29.09; 27.15 milliseconds

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Imaging (Diagnostic_test)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Johns Hopkins University
Primary completion
May 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
T1 Rho MRI Relaxation Time of Shoulder External Rotator (Milliseconds)		 29.09; 27.15 —
PRIMARY
T1 Rho MRI Relaxation Time of Shoulder Internal Rotator (Milliseconds)		 31.83; 30.96 —
PRIMARY
Ultrasound Shear Strain Percentage Between Paretic vs. Non-paretic Muscles		 46.54; 35.37 —
PRIMARY
Ultrasound Shear Strain Percentage Between Paretic vs. Non-paretic Side in Patients With High Severity Post Stroke Shoulder Pain		 47.46; 35.67 —

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05762679). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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