Effect of Cryoneurolysis on Pain in Patients With Hand Contracture. (NCT06051656) | Clinical Trial Compass
UnknownNot Applicable
Effect of Cryoneurolysis on Pain in Patients With Hand Contracture.
Canada25 participantsStarted 2023-01-09
Plain-language summary
Contracture which is defined as a limitation of the maximum passive range of motion due to changes in periarticular soft tissue can contributes to severe pain and increased disabilities. Once contracture is present, management options are very limited and mainly includes surgery. This clinic offers cryoneurolysis routinely to spastic patients to manage their severe spasticity, contracture and associated pain. In this observational project, the outcomes after cryoneurolysis in patients with wrist and hand contracture will be studied systematically and with more details to determine any changes in pain and range of motion after this procedure.
Who can participate
Age range
18 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 patients(at least 18 years old).
. Severe claw hand with less than 4 cm distance between the pulp of the fingers and palm of the hand.
. MAS\>= 3 in wrist and hand muscles interfering with function or causing a clinical problem, due to any neurological condition.
. Have refractory pain in wrist and hand areas with no response to the usual pain management methods including oral medication or botulinum toxin injection.
. Patients are already candidate for cryoneurolysis to manage the pain and spasticity in their hand and wrist, based on their response to diagnostic nerve block test (DNB).
. Ability to attend testing sessions, comply with testing protocols and provide written informed consent. For patients who physically are not able to complete the consent process, a witness may be asked to sign and confirm their willing for participation. Legal representative may be asked to help with consent process for participants who cognitively are not able to consent on their behalf.
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
Any changes in wrist and hand pain after cryoneurolysis.
Timeframe: The assessment will be done at baseline, 2 weeks, 1 and 4 months after the procedure.
2
Any changes in wrist and hand pain after cryoneurolysis , in patients who are not cognitively able to report the intensity of pain.
Timeframe: The assessment will be done at baseline, 2 weeks, 1 and 4 months after the procedure.
3
Any changes in wrist and hand spasticity and tone.
Timeframe: The assessment will be done at baseline, 2 weeks, one and four months after the procedure.
4
Any changes in wrist and hand range of motion will be recorded.
Timeframe: The assessment will be done at baseline, 2 weeks, one and four months after the procedure.
. Have undergone any previous peripheral nerve procedures in their affected side, for the treatment of spasticity, including previous cryoneurolysis, chemical neurolysis, neurectomy or arthroplasty.
. Patients who received botulinum toxin in past 4 months in the same targeted muscles for cryoneurolysis, however, they may enter the study at the 4-month mark.