Obturator Cryoneurotomy for Hip Adductor Spasticity

Spasticity, Muscle Clinical Trial

Official title:

Evaluating the Efficacy of Obturator Cryoneurotomy for Hip Adductor Spasticity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05147441
• Other study ID #: H21-01646
• Status: Recruiting
• Start date: August 10, 2021
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: Vancouver Island Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity, Muscle

Locations

Country	Name	City	State
Canada	Victoria General Hospital	Victoria	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Vancouver Island Health Authority

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

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. — View Citation

Tugui RD, Antonescu D. Cerebral palsy gait, clinical importance. Maedica (Bucur). 2013 Sep;8(4):388-93. — View 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. Erratum In: Clin Rehabil. 2010 Feb;24(2):191. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	Any changes in the ability to perform hygienic care related to degree of adductor muscles spasticity	The assessment will be based on a four-point scale: 0 means relatively easy and 3 means with severe difficulty (Viel et al.,2002)	The assessment will be done at baseline, 1 month after cryoneurotomy and then every 3 months up to one year.
Secondary	Any changes in 10-meter walk test.	Patients will be asked to walk in a designed area for 10 meter and twice. the result will be average time of 2 rounds and will be recorded as second.	The assessment will be done at baseline, 1 month after cryoneurotomy and then every 3 months up to one year.
Secondary	Any changes in patients' gait based on the physician's observation and the patient's perception.	The gait will be scored based on a 4-point scale: 0 will be assigned to patients with no difficulty in walking and 3 will be assigned to the patients who are unable to walk (Viel et al.,2002)	The assessment will be done at baseline, 1 month after cryoneurotomy and then every 3 months up to one year.
Secondary	Any changes in degree of pain if they have any.	Patients will be asked if they have any related pain and to score it based on 10-point scale, which 0means no pain and 10 means the worst pain that they ever experienced	The assessment will be done at baseline, 1 month after cryoneurotomy and then every 3 months up to one year.
Secondary	Patients satisfaction in achieving their goals after the procedure as assessed by Goal Attainment Scale (Turner-Stokes, 2009).	Based on this scale participants will be asked for 3 main goals that they desire to achieve after the intervention. The baseline score will be (-1) and they will be interviewed again at 6 and 12 months, to record how they reported their achievement. The scores of (-2), (-0.5), (0), (+1) and (+2) will be assigned if they feel that their condition is worst than before, better but not as good as expected, as expected, better than expected and much better than expected. All goals will be weighted equally, and final score will be calculated based on the available formula, in each session. The higher score is presenting of better outcome	The follow up will be done up to one year.