Obturator Cryoneurotomy for Hip Adductor Spasticity

  • STATUS
    Recruiting
  • End date
    Oct 13, 2023
  • participants needed
    20
  • sponsor
    Vancouver Island Health Authority
Updated on 13 December 2021

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

Description

Hip adductor spasticity is a common affliction amongst patients with disorders of the central nervous system. Spasticity affects as much as 60% of people with cerebral palsy, and up to 97% of patients with MS. Spasticity can be detrimental to gait, leading to lowered walking velocity, lack of stability and more frequent falls in conditions of the central nervous system, like cerebral palsy . Hip adductor spasticity can make it difficult for one to part their knees sufficiently to perform personal hygiene and can lead to extreme difficulties dressing and performing other activities of daily living. A lack of ability to perform activities of daily living leads to lessened independence. In this study, we will measure the efficacy of obturator cryoneurotomy for patients with spastic hip adduction as an alternative approach to more invasive, complicated and costly treatments.

Research Design

This project constitutes a single-centre, prospective cohort study. Data collection will occur at the Victoria General Hospital (VGH) multidisciplinary spasticity clinic, consisting of physiatrists, an orthopedic surgeon and physiotherapists. Patients with spasticity are referred to this clinic for different procedures including cryoneurotomy. This multidisciplinary spasticity clinic offers various treatments to spastic patients, including botulinum toxin injection, bracing, consultations for surgery or neurotomy. All procedures are offered to each patient. Most of the patients in the study will have already had Botox and bracing, or even neurotomy. As of yet all patients have had botulinum injections and bracing before cryoneurotomy. This study will not interfere or change the patients' medical care, and we will do the assessments for the patients who are already candidates for this procedure as a part of their treatment, besides other provided medical cares and have been accepted to receive that.

Patients who are already candidates for cryoneurotomy as a part of their treatment, will be invited to have an extra ten-meter walk test. All measures are part of the standard clinical assessment, except the 10 meter-walk test. The spasticity degree and range of motion will be measured for both limbs.

Details
Condition Spasticity, Muscle
Clinical Study IdentifierNCT05147441
SponsorVancouver Island Health Authority
Last Modified on13 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Will have cryoneurotomy as part of their standard treatment for spastic hip adductors in VGH spasticity multidisciplinary clinic
Are at least 12 years of age at the time of the procedure
Have the ability to attend testing sessions, comply with testing protocols and provide written informed consent
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

Have a history of previous nerve procedures such as chemical neurolysis with alcohol, cryoneurotomy, or any surgery to the obturator nerve
Have any other neurological pathology different from that responsible for the spasticity
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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