AzTrials
AzTrials

Spasticity, MuscleNCT05147441

Obturator Cryoneurotomy for Hip Adductor Spasticity

An observational study of Spasticity, Muscle, run by Vancouver Island Health Authority at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Spasticity, Muscle
How many people
20 participants
Where
1 siteCanada
Study dates
10 Aug 2021to Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site, 1 recruiting

  • Victoria General Hospital

    Victoria, British Columbia, V8Z 6R5

    Paul Winston, MD, 250-727-4221, Paul.winston@viha.ca

    Mahdis Hashemi, MD, 250-727-4221, mahdis.hashemi@viha.ca

    Recruiting

Other trials in Canada

About this study

Official title: Evaluating the Efficacy of Obturator Cryoneurotomy for Hip Adductor Spasticity

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

Read the 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.

Keywords
spasticity, Cryoneurotomy, Hip adductors, Range of motion
Medical subject headings
Muscle Spasticity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: measurement will be done at baseline, 1 month after having Cryoneurotomy and then every 3 months up to one year.

  2. 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

    Measured: measurement will be done at baseline, 1 month after having Cryoneurotomy and then every 3 months up to one year.

  3. 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).

    Measured: measurement will be done at baseline, 1 month after having Cryoneurotomy and then every 3 months up to one year.

  4. 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

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

Secondary outcomes (5)

  1. 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)

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

  2. 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.

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

  3. 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)

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

  4. 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

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

  5. 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

    Measured: The follow up will be done up to one year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2021
  2. Study start10 Aug 2021
  3. Primary completionOct 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05147441
Sponsor's protocol ID
H21-01646
Status last verified
Jun 2024
First submitted
2 Nov 2021
Last updated
14 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 12645447

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

    PubMed 24790675

  • 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.

    PubMed 27475282

  • 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.

    PubMed 11900470

  • 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.

    PubMed 19179355

Questions about this trial

What is this clinical trial studying?

An observational study of Spasticity, Muscle, run by Vancouver Island Health Authority at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the 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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05147441, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in