Cryoneurolysis for Knee and Shoulder Pain in an Inpatient Setting (NCT05674604) | Clinical Trial Compass
UnknownNot Applicable
Cryoneurolysis for Knee and Shoulder Pain in an Inpatient Setting
Canada25 participantsStarted 2022-10-10
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. In addition to their chief complaint, are also affected by one or both of the following
. Hemiplegic shoulder pain,
. Knee pain due to osteoarthritis
. Patients who are already candidate for cryoneurolysis.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
to determine any changes in shoulder pain, after the cryoneurolysis.
Timeframe: The measurement will be done at baseline, 1 week, 1 and 4 months after the procedure.
2
to determine any changes in shoulder pain, based on physician's assessment, after the cryoneurolysis.
Timeframe: The measurement will be done at baseline, 1 week, 1 and 4 months after the procedure.
3
to determine any changes in knee pain, after the cryoneurolysis
Timeframe: The measurement will be done at baseline, 1 week, 1 and 4 months after the procedure.
4
the degree of range of motion changes after the cryoneurolysis.
Timeframe: The assessment will be done before and 1 week, 1 and 4 months after the procedure.
5
The degree of changes in targeted muscles tone.
Timeframe: The assessment will be done before and 1 week, 1 and 4 months after the procedure.
. 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
. 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.
. Patients who received botulinum toxin in the past 4 months in the same targeted muscles for cryoneurolysis