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 range18 Years
SexALL
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Inclusion criteria
ā. Adult patients(at least 18 years old).
ā. Severe claw hand with less than 4 cm distance between the pulp of the fingers and palm of the hand.
ā. MAS\>= 3 in wrist and hand muscles interfering with function or causing a clinical problem, due to any neurological condition.
ā. Have refractory pain in wrist and hand areas with no response to the usual pain management methods including oral medication or botulinum toxin injection.
ā. 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).
ā. 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.
Exclusion criteria
ā. Have undergone any previous peripheral nerve procedures in their affected side, for the treatment of spasticity, including previous cryoneurolysis, chemical neurolysis, neurectomy or arthroplasty.
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.
ā. 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.