Cryoneurolysis treatment for knee and shoulder pain in stroke patients

Cryoneurolysis as a Drug Free Novel Treatment for Knee and Shoulder Pain Impairing Inpatient Neurological Rehabilitation

This study tests if a new treatment called cryoneurolysis can help stroke patients with knee and shoulder pain feel better and improve their ability to participate in rehabilitation.

Quick facts

• Study type: Observational
• Enrollment: 25 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Vancouver Island Health Authority (Academic / other)
• Locations: 1 site (Victoria, British Columbia)
• Trial ID: NCT05674604 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of cryoneurolysis, a minimally invasive procedure, in reducing shoulder and knee pain in patients who have recently experienced a stroke. The primary goal is to enhance patient engagement in rehabilitation by alleviating pain and improving function and quality of life. Secondary objectives include decreasing reliance on analgesic medications, increasing independence, and improving range of motion through a collaborative interdisciplinary care approach. The study focuses on patients within sixteen weeks post-stroke or neurological event, assessing their eligibility based on specific pain conditions.

Who should consider this trial

Good fit: Ideal candidates are adult inpatients with acute neurological conditions, specifically those experiencing hemiplegic shoulder pain or knee pain due to osteoarthritis.

Not a fit: Patients who do not have hemiplegic shoulder pain or knee pain related to osteoarthritis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve pain management and rehabilitation outcomes for stroke patients.

How similar studies have performed: While cryoneurolysis is a relatively novel approach, previous studies have shown promise in using nerve blocks and radiofrequency ablation for similar pain management.

Eligibility criteria

Inclusion Criteria:

1. Adult inpatients at any hospital in the Greater Victoria Area or referred to Victoria General hospital for rehabilitation with the chief complaint of an acute neurological condition (within sixteen weeks) including but not limited to stroke and traumatic brain injury. People that have had a stroke or neurological event within sixteen weeks but have been discharged to outpatient rehab at Victoria General Hospital are also candidates
2. In addition to their chief complaint, are also affected by one or both of the following

   1. Hemiplegic shoulder pain,
   2. Knee pain due to osteoarthritis
3. Patients who are already candidate for cryoneurolysis.
4. Ability to attend testing sessions, comply with testing protocols and provide either written or verbal informed consent. If necessary, a witness will be asked to sign the consent form and confirm the participant signature. For those patients who do not have the capacity to sign the consent form(Based on evaluation by PI or the recorded assessment by their physician in their medical charts) the designated care provider or family member will be asked to sign the ICF on behalf of them. Evaluation of the capacity to understand and communicate are part of routine assessment and are done routinely and each visit by physicians.
5. Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator).

Exclusion Criteria:

1. Have undergone any previous peripheral nerve procedures in their affected side, for the treatment of spasticity or pain. Relevant treatments included but not limited to previous cryoneurolysis, previous chemical neurolysis, neurectomy or arthroplasty.
2. Patients who received botulinum toxin in the past 4 months in the same targeted muscles for cryoneurolysis

Where this trial is running

Victoria, British Columbia

• Victoria General Hospital — Victoria, British Columbia, Canada (Recruiting)

Study contacts

• Principal investigator: Paul Winston, MD — Vancouver Island Health Authority
• Study coordinator: Mahdis Hashemi, MD

Conditions Shoulder Pain; Knee Pain; Spasticity; Pain; Acute Stroke; Cryoneurolysis; shoulder pain; knee pain