Hyaluronidase for Stroke-Related Shoulder Pain

Overseen By Preeti Raghavan

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Johns Hopkins University

Must not be taking: Botulinum toxin, Baclofen, Phenol

Disqualifiers: Parkinson's, ALS, MS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 5-7 weeks

68 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether hyaluronidase, an enzyme treatment, can reduce shoulder pain in individuals who have experienced a stroke. Shoulder pain after a stroke is common and can hinder movement, impacting quality of life. Researchers are examining two groups: one receives hyaluronidase with saline, while the other receives only saline. Individuals who have had a stroke and experience difficulty moving their shoulder, with or without pain, may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have had certain treatments for spasticity recently or are adjusting anti-spastic medications.

Is there any evidence suggesting that hyaluronidase is likely to be safe for humans?

A previous study found that injections of hyaluronidase for shoulder pain after a stroke were safe, with no serious side effects reported. This treatment is considered safer than other options, such as corticosteroid injections. Research has also shown that hyaluronic acid can help relieve pain and improve shoulder movement in stroke patients. Evidence so far suggests that hyaluronidase is well-tolerated, making it a promising option for managing shoulder pain after a stroke. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for stroke-related shoulder pain?

Most treatments for stroke-related shoulder pain, like physical therapy and medications such as NSAIDs or corticosteroids, focus on reducing inflammation and improving mobility over time. However, hyaluronidase is unique because it breaks down hyaluronic acid, a component that can contribute to tissue stiffness and pain. This mechanism potentially offers quicker relief by enhancing tissue permeability and reducing pressure in the affected area. Researchers are excited about hyaluronidase because it could offer a new, faster-acting option for managing shoulder pain after a stroke, which is a significant improvement over conventional treatments.

What evidence suggests that hyaluronidase might be an effective treatment for post-stroke shoulder pain?

This trial will compare the effects of hyaluronidase plus saline with a saline injection alone for stroke-related shoulder pain. Research has shown that hyaluronic acid, related to the enzyme hyaluronidase, can reduce shoulder pain and improve movement in stroke patients. Studies have found that injecting hyaluronic acid can lead to less pain and better shoulder movement in individuals with paralysis on one side of their body after a stroke. This treatment addresses issues with the tissues around muscles, which can cause pain. By breaking down excess hyaluronic acid that accumulates in the muscles, hyaluronidase may improve muscle movement and reduce pain. Although more research is needed, these findings suggest that hyaluronidase could provide relief for those suffering from shoulder pain after a stroke. ^{1 2 6 7 8}

Who Is on the Research Team?

Ning Cao, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have had a stroke between 3 to 180 months ago, leading to hemiparesis (weakness on one side of the body). They must be able to consent and follow study rules. Eligible participants show at least a 10-degree difference in shoulder movement range between their affected and unaffected sides, with or without pain.

Inclusion Criteria

I had a brain injury between 3 to 180 months ago.

I have weakness on one side of my body due to a stroke.

I can understand and agree to the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive hyaluronidase or saline injections to treat post-stroke shoulder pain

5-7 weeks

5 visits (in-person)

Follow-up

Participants are monitored for changes in T1ρ relaxation times, pain, range of motion, and quality of life

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• hyaluronidase

Trial Overview The trial is testing whether injecting hyaluronidase mixed with saline into the shoulder can help relieve pain better than saline alone. This study aims to see if breaking down hyaluronic acid buildup improves muscle function and reduces pain in post-stroke patients.

How Is the Trial Designed?

Group I: Saline injection (Control Arm) Experimental Treatment 1 Intervention

normal saline injection

Group II: Hyaluronidase plus saline (Treatment Arm) Experimental Treatment 1 Intervention

hyaluronidase plus saline injection

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

Hyaluronidase, an enzyme that breaks down hyaluronic acid, has shown to be well-tolerated in the human central nervous system and rabbit eyes, suggesting a potential for safe use in neurological conditions.

In three patients with hydrocephalus and related conditions, intraventricular injections of hyaluronidase effectively managed symptoms, delayed the need for shunting, and prevented fluid reaccumulation, indicating its potential therapeutic efficacy in central nervous system disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of hyaluronidase in the central nervous system. Gegalian, L.[2004]

Intra-articular injection of hyaluronic acid (HA) significantly reduces pain and improves function in patients with rotator cuff tears, based on a systematic review of 11 studies involving 1102 patients.

The review found no severe adverse reactions associated with HA injections, indicating that it is a safe treatment option compared to corticosteroid injections and other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evidence in the treatment of rotator cuff tears with hyaluronic acid. Osti, L., Buda, M., Buono, AD., et al.[2022]

Citations

1. withpower.com withpower.com/trial/hyaluronidase-for-stroke-related-shoulder-pain-b48be

Hyaluronidase for Stroke-Related Shoulder Pain Research shows that hyaluronic acid, a component related to hyaluronidase, can help reduce shoulder pain and improve movement in stroke patients. Additionally, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6392532/

The long-term effects of hyaluronic acid on hemiplegic ... Hyaluronic acid (HA) could have positive effects on pain relief and shoulder motion in stroke patients with hemiplegic shoulders.

3. journals.lww.com journals.lww.com/md-journal/fulltext/2018/08310/the_long_term_effects_of_hyaluronic_acid_on.56.aspx

The long-term effects of hyaluronic acid on hemiplegic... Hyaluronic acid (HA) could have positive effects on pain relief and shoulder motion in stroke patients with hemiplegic shoulders.

4. e-arm.org e-arm.org/journal/view.php?number=753

Effect of Intra-articular Hyaluronic Acid Injection on Hemiplegic ... Abstract. Objective. To evaluate the efficacy of intra-articular hyaluronic acid (IAHA) injection for hemiplegic shoulder pain (HSP) after stroke.

5. dovepress.com dovepress.com/interventions-for-post-stroke-shoulder-pain-an-overview-of-systematic--peer-reviewed-fulltext-article-IJGM

Interventions for Post-Stroke Shoulder Pain: An Overview ... A number of systematic reviews indicate significant reductions in pain, with a wide range of treatments appearing promising.

6. trials.arthritis.org trials.arthritis.org/trials/NCT06718413

Myofascial Dysfunction in Post Stroke Shoulder Pain 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 ...

7. cochranelibrary.com cochranelibrary.com/central/doi/10.1002/central/CN-01626868/

The long-term effects of hyaluronic acid on hemiplegic ... The long-term effects of hyaluronic acid on hemiplegic shoulder pain and injury in stroke patients: a randomized controlled study.

8. clinicaltrials.eu clinicaltrials.eu/inn/hyaluronidase/

HYALURONIDASE – Application in Therapy and Current ... **Treatment of post-stroke shoulder pain**: Research is investigating whether hyaluronidase injections can help reduce pain and improve range of motion in ...