Recruiting

Obturator Cryoneurotomy

Sponsor:

Vancouver Island Health Authority

Code:

NCT05147441

Conditions

Spasticity, Muscle

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of the study is to measure the effects of obturator nerve cryoneurotomy, on clinical measures in adult (ages 19+) and paediatric (ages 12-18) patients with hip adductor spasticity, who will receive this procedure as a part of their treatment based on the spasticity treatment available guidelines. The results will provide us valuable information like how long cryoneurotomy is effective, before regeneration happens

Conditions

Spasticity, Muscle

Study ID

NCT05147441

Start date

Aug 10, 2021

Status verified date

Jun, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Oct, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Will have cryoneurotomy as part of their standard treatment for spastic hip adductors in VGH spasticity multidisciplinary clinic.
2. Are at least 12 years of age at the time of the procedure.
3. Have the ability to attend testing sessions, comply with testing protocols and provide written informed consent.
4. Are 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 a history of previous nerve procedures such as chemical neurolysis with alcohol, cryoneurotomy, or any surgery to the obturator nerve.
2. Have any other neurological pathology different from that responsible for the spasticity.

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • The degree of changes in hip abductors' active range of motion. [ Time Frame: measurement will be done at baseline, 1 month after having Cryoneurotomy and then every 3 months up to one year. ]
  • The degree of changes in hip abductors' maximum passive range of motion. [ Time Frame: measurement will be done at baseline, 1 month after having Cryoneurotomy and then every 3 months up to one year. ]
  • The degree of changes in hip abductors' spasticity [ Time Frame: measurement will be done at baseline, 1 month after having Cryoneurotomy and then every 3 months up to one year. ]
  • The degree of changes in inter knees distance at maximum passive hip abduction range of motion [ Time Frame: It will be done at baseline, 1 month after cryoneurotomy and then every 3 months up to 12 months ]

Central Contacts and Locations

Locations

Victoria General Hospital

Recruiting

Victoria, British Columbia, Canada, V8Z 6R5

Contacts

Paul Winston, MD

250-727-4221Paul.winston@viha.ca

Mahdis Hashemi, MD

250-727-4221mahdis.hashemi@viha.ca

Principal Investigator:

Paul Winston, MD

More Information

Sponsor

Vancouver Island Health Authority

Last update posted

Jun 14, 2024

Last verified

Jun, 2024

Keywords

  • spasticity
  • Cryoneurotomy
  • Hip adductors
  • Range of motion

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.