Clinical trial NCT05147441: Obturator Cryoneurotomy for Hip Adductor Spasticity
Official title: Evaluating the Efficacy of Obturator Cryoneurotomy for Hip Adductor Spasticity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spasticity, Muscle
Keywords: spasticity
Cryoneurotomy
Hip adductors
Range of motion
Lead sponsor: Vancouver Island Health Authority
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are at least 12 years old and will have Cryoneurotomy as a part of their provided medical care will be asked to be enrolled in the study. All patients will be recruited through multidisciplinary spasticity clinic in Victoria General Hospital where spastic patients are referred to this center routinely.

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The degree of changes in hip abductors' active range of motion.
timeFrame: measurement will be done at baseline, 1 month after having Cryoneurotomy and then every 3 months up to one year.
measure: The degree of changes in hip abductors' maximum passive range of motion.
timeFrame: measurement will be done at baseline, 1 month after having Cryoneurotomy and then every 3 months up to one year.
measure: The degree of changes in hip abductors' spasticity
timeFrame: measurement will be done at baseline, 1 month after having Cryoneurotomy and then every 3 months up to one year.
measure: The degree of changes in inter knees distance at maximum passive hip abduction range of motion
timeFrame: It will be done at baseline, 1 month after cryoneurotomy and then every 3 months up to 12 months
Secondary outcomes:
measure: Any changes in the ability to perform hygienic care related to degree of adductor muscles spasticity
timeFrame: The assessment will be done at baseline, 1 month after cryoneurotomy and then every 3 months up to one year.
measure: Any changes in 10-meter walk test.
timeFrame: The assessment will be done at baseline, 1 month after cryoneurotomy and then every 3 months up to one year.
measure: Any changes in patients' gait based on the physician's observation and the patient's perception.
timeFrame: The assessment will be done at baseline, 1 month after cryoneurotomy and then every 3 months up to one year.
measure: Any changes in degree of pain if they have any.
timeFrame: The assessment will be done at baseline, 1 month after cryoneurotomy and then every 3 months up to one year.
measure: Patients satisfaction in achieving their goals after the procedure as assessed by Goal Attainment Scale (Turner-Stokes, 2009).
timeFrame: The follow up will be done up to one year.
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: Victoria General Hospital
state: British Columbia
Study officials:
References:
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citation: Viel EJ, Perennou D, Ripart J, Pelissier J, Eledjam JJ. Neurolytic blockade of the obturator nerve for intractable spasticity of adductor thigh muscles. Eur J Pain. 2002;6(2):97-104. doi: 10.1053/eujp.2001.0269.
citation: Turner-Stokes L. Goal attainment scaling (GAS) in rehabilitation: a practical guide. Clin Rehabil. 2009 Apr;23(4):362-70. doi: 10.1177/0269215508101742. Epub 2009 Jan 29.