Treatment for shoulder pain after stroke

Quantifying and Treating Myofascial Dysfunction in Post Stroke Shoulder Pain

This study is testing whether hyaluronidase injections can help reduce shoulder pain in stroke survivors and improve their movement and quality of life.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Johns Hopkins University (Academic / other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT06718413 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to investigate the effectiveness of hyaluronidase injections in reducing shoulder pain associated with post-stroke myofascial dysfunction. It will utilize T1rho MRI and ultrasound shear strain mapping to quantify changes in muscle function and pain levels before and after treatment. The study will compare the outcomes of patients receiving hyaluronidase versus a placebo, focusing on pain reduction, range of motion, and overall quality of life. The trial seeks to clarify the role of hyaluronic acid accumulation in shoulder pain post-stroke.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have experienced hemiparesis from a stroke and exhibit specific shoulder mobility issues.

Not a fit: Patients with other neurological conditions or significant cognitive dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate shoulder pain and improve recovery outcomes for stroke patients.

How similar studies have performed: While the approach of using hyaluronidase for myofascial dysfunction is novel, similar studies have shown promise in treating pain through targeted interventions.

Eligibility criteria

Inclusion Criteria:

* age ≥18 years;
* hemiparesis from an ischemic or hemorrhagic stroke;
* time since cerebral injury 3-180 months prior;
* show a difference of more than 10 degrees of passive ER-ROM between non-paretic and paretic shoulders with or without pain
* ability to give informed consent and HIPAA authorization, and comply with study protocols;

Exclusion Criteria:

* treatment of spasticity with Botulinum toxin or intrathecal baclofen within the past three months, phenol injections within the past 12 months, or ongoing adjustment of anti-spastic medications;
* other neurologic condition that may affect motor response (e.g., Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), MS);
* clinically significant cognitive dysfunction with score \<19 on Folstein's Mini Mental Status Examination or positive depression screening on the Patient Health Questionnaire (PHQ)-9;
* pregnancy;
* known hypersensitivity to hyaluronidase;
* standard contraindications for MRI;
* have non-musculoskeletal PSSP such as only central pain or chronic regional pain syndrome (CRPS)
* any condition that will preclude the patient from completing the protocol as determined by the PI.

Where this trial is running

Baltimore, Maryland

• Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Ning Cao, MD — Johns Hopkins University
• Study coordinator: Ning Cao, MD

Conditions Stroke