NCT05674604 Cryoneurolysis for Knee and Shoulder Pain in an Inpatient Setting
| NCT ID | NCT05674604 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vancouver Island Health Authority |
| Condition | Shoulder Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 25 participants |
| Start Date | 2022-10-10 |
| Primary Completion | 2024-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25 participants in total. It began in 2022-10-10 with a primary completion date of 2024-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to measure the outcomes of a standard care, an ultrasound guided mini-invasive percutaneous procedure, performed on recent stroke patients on reduces pain, increases function \& quality of life The primary objective of the project is to reduce shoulder and/or knee pain in patients who have had a stroke so that they can more readily engage in rehabilitation. Secondary objectives are to reduce analgesic medications, increase independence and improve range of motion, to promote non-drug treatment measures in the medical toolkit, and to include an interdisciplinary care team in patient selection for interventions.
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
Contact & Investigator
Paul Winston, MD
PRINCIPAL INVESTIGATOR
Vancouver Island Health Authority
Frequently Asked Questions
Who can join the NCT05674604 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Shoulder Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05674604 currently recruiting?
Yes, NCT05674604 is actively recruiting participants. Contact the research team at mahdis.hashemi@islandhealth.ca for enrollment information.
Where is the NCT05674604 trial being conducted?
This trial is being conducted at Victoria, Canada.
Who is sponsoring the NCT05674604 clinical trial?
NCT05674604 is sponsored by Vancouver Island Health Authority. The principal investigator is Paul Winston, MD at Vancouver Island Health Authority. The trial plans to enroll 25 participants.