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New treatment option for Stroke
Official title Myofascial Dysfunction in Post Stroke Shoulder Pain
ClinicalTrials.gov ID: NCT06718413
What this study is testing
What is hyaluronidase plus saline?
hyaluronidase plus saline is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for stroke.
Also referred to as Treatment Arm.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Shoulder pain is extremely common after stroke and occurs in 30-70% of patients. The pain may begin as early as one week after stroke, although peak onset and severity occurs around four months, and persists into the chronic stage.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
You likely can't join if
- treatment of spasticity with Botulinum toxin or intrathecal baclofen within the past three months, phenol injections within the past 12 months, or...
- 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...
- pregnancy;
- known hypersensitivity to hyaluronidase;
- standard contraindications for MRI;
See the full eligibility 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;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.