Recruiting

Cryoneurolysis

Sponsor:

Vancouver Island Health Authority

Code:

NCT05674604

Conditions

Shoulder Pain

Knee Pain

Spasticity

Pain

Acute Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Cryoneurolysis

Study Details

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.

Conditions

Shoulder Pain

Knee Pain

Spasticity

Pain

Acute Stroke

Study ID

NCT05674604

Start date

Oct 10, 2022

Status verified date

Jun, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Oct, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants

Adult inpatients who are referred to Victoria General Hospital for rehabilitation with the chief complaint of an acute neurological disorder such as stroke, within next 16 weeks, and suffer from shoulder and/or knee pain. All potential participants are already candidate for cryoneurolysis to mange their shoulder or knee pain.

Interventions

Cryoneurolysis

This is on observational study. All participants are already candidate for cryoneurolysis. Cryoneurolysis uses a cold probe to generate an ice ball, which initiates Wallerian Degeneration, a process where axon is destroyed but the epineurium and perineurium remain intact. The treated nerve is able to regenerate over time due to this preserved tube.

Primary outcome measure

  • to determine any changes in shoulder pain, after the cryoneurolysis. [ Time Frame: The measurement will be done at baseline, 1 week, 1 and 4 months after the procedure. ]
  • to determine any changes in shoulder pain, based on physician's assessment, after the cryoneurolysis. [ Time Frame: The measurement will be done at baseline, 1 week, 1 and 4 months after the procedure. ]
  • to determine any changes in knee pain, after the cryoneurolysis [ Time Frame: The measurement will be done at baseline, 1 week, 1 and 4 months after the procedure. ]
  • the degree of range of motion changes after the cryoneurolysis. [ Time Frame: The assessment will be done before and 1 week, 1 and 4 months after the procedure. ]
  • The degree of changes in targeted muscles tone. [ Time Frame: The assessment will be done before and 1 week, 1 and 4 months after the procedure. ]

Central Contacts and Locations

Central contacts

Locations

Victoria General Hospital

Recruiting

Victoria, British Columbia, Canada, V8Z 6R5

Contacts

Principal Investigator:

Paul Winston, MD

More Information

Sponsor

Vancouver Island Health Authority

Last update posted

Jun 14, 2024

Last verified

Jun, 2024

Keywords

  • Cryoneurolysis
  • shoulder pain
  • knee pain
  • spasticity
  • acute stroke
  • In-patient setting

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vancouver Island Health Authority on 2024-06-14.