Recruiting

Cryoneurolysis

Sponsor:

Vancouver Island Health Authority

Code:

NCT06051656

Conditions

Contracture

Spasticity, Muscle

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Contracture

Spasticity, Muscle

Study ID

NCT06051656

Start date

Jan 9, 2023

Status verified date

Sep, 2023

Completion date

Sep, 2024

Anticipated

Primary completion date

Jun, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adult patients(at least 18 years old).
2. Severe claw hand with less than 4 cm distance between the pulp of the fingers and palm of the hand.
3. MAS>= 3 in wrist and hand muscles interfering with function or causing a clinical problem, due to any neurological condition.
4. Have refractory pain in wrist and hand areas with no response to the usual pain management methods including oral medication or botulinum toxin injection.
5. 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).
6. 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:

1. Have undergone any previous peripheral nerve procedures in their affected side, for the treatment of spasticity, including previous cryoneurolysis, chemical neurolysis, neurectomy or arthroplasty.
2. 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.

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

Case group

Any adult patient with severe hand and wrist spasticity or contracture who suffers from a refractory pain, and is already candidate for cryoneurolysis.

Primary outcome measure

  • Any changes in wrist and hand pain after cryoneurolysis. [ Time Frame: The assessment will be done at baseline, 2 weeks, 1 and 4 months after the procedure. ]
  • Any changes in wrist and hand pain after cryoneurolysis , in patients who are not cognitively able to report the intensity of pain. [ Time Frame: The assessment will be done at baseline, 2 weeks, 1 and 4 months after the procedure. ]
  • Any changes in wrist and hand spasticity and tone. [ Time Frame: The assessment will be done at baseline, 2 weeks, one and four months after the procedure. ]
  • Any changes in wrist and hand range of motion will be recorded. [ Time Frame: The assessment will be done at baseline, 2 weeks, one and four months after the procedure. ]

Central Contacts and Locations

Central contacts

Mahdis Hashemi, MD

250-727-4233mahdis.hashemi@islandhealth.ca

Locations

Victoria General Hospital

Recruiting

Victoria, British Columbia, Canada, V8Z 6R5

Contacts

Mahdis Hashemi, MD

250-727-4233mahdis.hashemi@islandhealth.ca

More Information

Sponsor

Vancouver Island Health Authority

Last update posted

Oct 3, 2023

Last verified

Sep, 2023

Keywords

  • Wrist contracture
  • Severe spasticity
  • Pain
  • Cryoneurolysis
  • Hand contracture

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 2023-10-03.