Obturator Cryoneurotomy for Hip Adductor Spasticity

NCT05147441 | Recruiting

• 1 other identifier: H21-01646
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

spasticity; Cryoneurotomy; Hip adductors; Range of motion

Outcome Measures

Primary Outcomes (4)

• The degree of changes in hip abductors' active range of motion.

  any changes in active passive hip abduction range of motion will be measured by trained examiners with a standard goniometer.

  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.

  any changes in maximum passive hip abduction range of motion will be measured by trained examiners with a standard goniometer

  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

  any changes in hip abduction will be measured based on Modified Ashworth Scale, which has 6 scores (from 0 which means no spasticity to 4 which means the highest degree of the spasticity).

  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

  The measurement will be done by measure tape and based on centimetre scale

  It will be done at baseline, 1 month after cryoneurotomy and then every 3 months up to 12 months

Secondary Outcomes (5)

• Any changes in the ability to perform hygienic care related to degree of adductor muscles spasticity

  The assessment will be done at baseline, 1 month after cryoneurotomy and then every 3 months up to one year.

• Any changes in 10-meter walk test.

  The assessment will be done at baseline, 1 month after cryoneurotomy and then every 3 months up to one year.

• Any changes in patients' gait based on the physician's observation and the patient's perception.

  The assessment will be done at baseline, 1 month after cryoneurotomy and then every 3 months up to one year.

• Any changes in degree of pain if they have any.

  The assessment will be done at baseline, 1 month after cryoneurotomy and then every 3 months up to one year.

• Patients satisfaction in achieving their goals after the procedure as assessed by Goal Attainment Scale (Turner-Stokes, 2009).

  The follow up will be done up to one year.

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vancouver Island Health Authority: lead

Study Sites (1)

Victoria General Hospital

Victoria, British Columbia, V8Z 6R5, Canada

RECRUITING

Related Publications (5)

• Barnes MP, Kent RM, Semlyen JK, McMullen KM. Spasticity in multiple sclerosis. Neurorehabil Neural Repair. 2003 Mar;17(1):66-70. doi: 10.1177/0888439002250449.

  PMID: 12645447 BACKGROUND

• Tugui RD, Antonescu D. Cerebral palsy gait, clinical importance. Maedica (Bucur). 2013 Sep;8(4):388-93.

  PMID: 24790675 BACKGROUND

• Mlinac ME, Feng MC. Assessment of Activities of Daily Living, Self-Care, and Independence. Arch Clin Neuropsychol. 2016 Sep;31(6):506-16. doi: 10.1093/arclin/acw049. Epub 2016 Jul 29.

  PMID: 27475282 BACKGROUND

• 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.

  PMID: 11900470 BACKGROUND

• 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.

  PMID: 19179355 BACKGROUND

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: December 7, 2021
• Study Start: August 10, 2021
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)