No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
68 (estimated)
Sponsor
Johns Hopkins University · Other
Who this trial is looking for
This trial is looking for people who have shoulder pain after having a stroke. Participants will be asked to meet certain criteria and take part in assessments to understand the pain better.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older
I have weakness on one side of my body from a stroke
It has been 3 to 180 months since my stroke
I have more than a 10-degree difference in shoulder movement compared to my other shoulder
I can give consent and follow study rules
You may not be able to join if
I have had spasticity treatment in the last three months
I have another neurological condition that affects movement
I have significant memory problems or depression
I am pregnant
I am allergic to hyaluronidase
I have issues that prevent MRI scans
I have pain that is not related to my muscles
I cannot follow the study requirements as determined by the study doctor
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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. Chronic post stroke shoulder pain (PSSP) interferes with motor recovery, decreases quality of life, and contributes to depression. PSSP is thought to be caused mainly b…
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. Chronic post stroke shoulder pain (PSSP) interferes with motor recovery, decreases quality of life, and contributes to depression. PSSP is thought to be caused mainly by damage to the myofascial tissues around the shoulder joint. Interestingly, an MRI study in patients with PSSP showed that the degree of structural damage to the muscles did not correlate with the degree of pain. Thus, 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 hyaluronic acid (HA) in muscle and its fascia can cause myofascial dysfunction. HA is a glycosaminoglycan (GAG) consisting of long-chain polymers of disaccharide units of glucuronic acid and N-acetylglucosamine and is a chief constituent of the extracellular matrix of muscle. In physiologic quantities, HA functions as a lubricant and a viscoelastic shock absorber, enabling force transmission during contraction and stretch. Reduced joint mobility and spasticity result in focal accumulation and alteration of HA in muscle. This can lead to the development of stiff areas and taut bands, dysfunctional gliding of deep fascia and muscle layers, reduced range of motion (ROM), and pain. However, the association of muscle HA accumulation with PSSP has not been established.
The investigators have quantified the concentration of HA in muscle using T1rho (T1ρ) MRI and found that T1ρ relaxation time is increased in post stroke shoulder pain and stiffness. Furthermore, dynamic US imaging using shear strain mapping can quantify dysfunctional gliding of muscle that may generate pain during ROM. Myofascial dysfunction can result in non-painful reduction in ROM (latent PSSP), which may become painful due to episodic overuse injury producing greater shear dysfunction (active PSSP). Hence, shear strain mapping may differentiate between latent versus active PSSP. Thus, quantitative Motor Recovery (MR) and US imaging may serve as useful biomarkers to elucidate the pathophysiology of myofascial dysfunction.
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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…
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.
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