Muscle SpasticityNCT04907201
H-reflex in Spastic Lower Limb Cryoneurotomy
An observational study of Muscle Spasticity, run by Vancouver Island Health Authority at 1 site in Canada.
Trial summary
Spasticity is a common complication after many upper motor neurone disorders. Many surgical techniques have been introduced for patients with refractory spasticity though they are not without peri-operative risks. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Spasticity
- What is being tested?
- Cryoneurotomy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 15 Dec 2020to Nov 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any adult patient with lower limb spasticity who is already candidate for cryoneurotmy as a part of their medical care will be asked to be enrolled in the study.
Who may be able to join
- Patients who will have cryoneurotomy as part of their standard treatment for spastic equinovarus foot in VGH spasticity multidisciplinary clinic
- Adults 18-70 years of age (male and female)
- Ability to attend testing sessions, comply with testing protocols and provide written informed consent.
- 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).
- Any healthy participants with the age between 18 to 70. Over 70 will be excluded due to the expected natural alterations in electrophysiological parameters
- Able to attend and comply with the testing protocols
- Able to provide informed written consent
- Able to understand and speak English or have access to an appropriate interpreter
Who cannot join
- History of previous nerve procedures such as chemical neurolysis with alcohol, cryoneurotomy, any surgery of the tibial nerve.
- Any other neurological pathology different from that responsible for the spasticity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrophysiological Assessment of Cryoneurotomy in Spastic Lower Limbs.
Spasticity is a common complication after many upper motor neurone disorders. Many surgical techniques have been introduced for patients with refractory spasticity though they are not without peri-operative risks. Cryoneurotomy is another procedure which is cheaper, faster and less invasive in comparison to other surgical interventions. While many studies support the use of cryoneurotomy for pain relief, there are not much studies on use of cryoneurotomy to manage spasticity. The purpose of this study to measure the effect of tibial nerve cryoneurotomy on electrophysiological and clinical spasticity measures in adult patients with spastic equinovarus or equinus foot, who will receive this procedure as a part of their treatment based on spasticity treatment available guidelines. The results will provide us valuable information like how long cryoneurotomy is effective, before regeneration happens.
Read the detailed description
Different surgical techniques, including muscle and tendon lengthening and neurotomy/neurectomy (surgical sectioning of a peripheral nerve) are reserved for patients with refractory spasticity.
Cryoneurotomy which involves direct application of a low temperature probe to a nerve is another procedure, which is cheaper, faster and less invasive than surgical intervention, for the treatment of refractory spasticity. While many studies support using of cold temperature in pain relief (Ilfeld BM, 2017, Friedman, T. 2012), there are not much studies on use of cryoneurotomy to manage spasticity.This clinic has been using cryoneurotomy clinically with empiric success for 2.5 years. The initial results reveal significant increased active and passive range of motion in upper limbs and decreased clonus and improved gait after tibial neurotomy in lower limbs.
Spastic equinovarus foot (SEF) which is a common type of lower limb spasticity is typically treated with focal botulinum toxin injections, bracing and therapeutic exercise, although the drawback of these treatments is the need for serial injections and frequent interactions with health care providers. Recently selective tibial neurotomy has been shown to more definitively treat SEF (Bollens B, et al.2011, Deltombe T, et al. 2015), but as mentioned above this is an invasive approach. In light of our promising clinical experience with cryoneurotomy, we propose to prospectively and systematically measure its effect on SEF, as an alternative to more invasive surgical procedures and the typical multi-modal approach.
The data collection fro this project which is a single-centre, prospective cohort study will occur at the Victoria General Hospital (VGH) multidisciplinary spasticity clinic. Patients with spasticity are referred to this clinic for different procedures including cryoneurotomy. This study will not interfere or change the patients' medical care, and the assessments will be done 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.These participants will be invited to have an extra electrophysiological test for being enrolled in this study, which will be performed before the procedure and at 1, 3 and 12 months after cryoneurotomy. In addition, the results of their routine physical examinations including spasticity degree and ankle passive range of motion will be collected in this study.
- Conditions
- Muscle Spasticity
- Being tested
- Cryoneurotomy
- Keywords
- spasticity, Lower limb, H reflex, Cryoneurotomy, Range of motion
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoneurotomyProcedure or surgery
Also called nerve cryoablation
Cryoneurotomy or application of a low temperature probe with guidance of ultrasound which is offered to the patients with lower limbs refractory spasticity as a part of their medical cares.
| Study group | Role | What they receive |
|---|---|---|
| Patients | A group pf 30 patients with lower limb spasticity who are already candidate for cryoneurotomy will be invited to have an extra electrophysiological test for participation in this study. The test will be done for both limbs for a better comparison. Receives: Procedure: Cryoneurotomy | |
| Healthy participants | A group of 30 healthy participants will be invited as a control group, and they will have a single session of electrodiagnostic test for their lower limb in dominant side. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any changes in H max to M max amplitude ratio (H/ M ratio)
The ratio of maximum H reflex amplitude to maximum M wave amplitude as another electrophysiological analog for spasticity will be measured by a commercially available clinical electrodiagnosis machine before the procedure and at 1, 3 and 12 months after it. The results will be presented as a ratio and percentage.
Measured: up to 12 months
Changes in maximum H reflex amplitude
The maximum H reflex amplitude as an analog of spasticity as it measure excitability of the monosynaptic reflex arc will be assessed by a commercially available clinical electrodiagnosis machine. The assessment will be done before the procedure and at 1, 3 and 12 months after it and at both sides. The measurement unit will be millivolt (mV).
Measured: up to 12 months after procedure
Secondary outcomes (2)
Degree of changes in ankle dorsi-flexion spasticity as measured by Modified Ashworth Scale (MAS)
MAS has 6 scales from 0 to 4 (0,1,1+,2,3,4) which 0 means no spasticity and 4 means the maximum spasticity and the affected limb is rigid in its position.The assessment will be done by a trained examiner which is not enrolled in providing medical care and will be done before the procedure and at 1, 3 and 12 months after the procedure.
Measured: up to 12 months after procedure
Degree of changes in ankle dorsiflexion range of motion
The active and maximum passive dorsiflexion range of motion will be measured by a goniometer and will be presented in degree. The test will be done before and at 1, 3 and 12 months after the procedure by a trained examiner who is not enrolled in providing medical care.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start15 Dec 2020
- Primary completionSep 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Muscle SpasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vancouver Island Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahdis Hashemi, Vancouver Island Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907201
- Sponsor's protocol ID
- H20-02294
- Status last verified
- Jun 2024
- First submitted
- 25 May 2021
- Last updated
- 14 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bollens B, Deltombe T, Detrembleur C, Gustin T, Stoquart G, Lejeune TM. Effects of selective tibial nerve neurotomy as a treatment for adults presenting with spastic equinovarus foot: a systematic review. J Rehabil Med. 2011 Mar;43(4):277-82. doi: 10.2340/16501977-0786.
PubMed 21305231Deltombe T, Bleyenheuft C, Gustin T. Comparison between tibial nerve block with anaesthetics and neurotomy in hemiplegic adults with spastic equinovarus foot. Ann Phys Rehabil Med. 2015 Apr;58(2):54-9. doi: 10.1016/j.rehab.2014.12.003. Epub 2015 Jan 9.
PubMed 25614022Friedman T, Richman D, Adler R. Sonographically guided cryoneurolysis: preliminary experience and clinical outcomes. J Ultrasound Med. 2012 Dec;31(12):2025-34. doi: 10.7863/jum.2012.31.12.2025.
PubMed 23197557Ilfeld BM, Gabriel RA, Trescot AM. Ultrasound-guided percutaneous cryoneurolysis for treatment of acute pain: could cryoanalgesia replace continuous peripheral nerve blocks? Br J Anaesth. 2017 Oct 1;119(4):703-706. doi: 10.1093/bja/aex142. No abstract available.
PubMed 29121277
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Assessment of Cryoneurotomy in Spastic Lower Limbs.
- ClinicalTrials.gov ID
- NCT04907201
- Acronym / sponsor ID
- H20-02294
- Conditions
- Muscle Spasticity
- Keywords
- spasticity, Lower limb, H reflex, Cryoneurotomy, Range of motion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Vancouver Island Health AuthorityUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Spasticity is a common complication after many upper motor neurone disorders. Many surgical techniques have been introduced for patients with refractory spasticity though they are not without peri-operative risks. Cryoneurotomy is another procedure which is cheaper, faster and less invasive in comparison to other surgical interventions. While many studies support the use of cryoneurotomy for pain relief, there are not much studies on use of cryoneurotomy to manage spasticity. The purpose of this study to measure the effect of tibial nerve cryoneurotomy on electrophysiological and clinical spasticity measures in adult patients with spastic equinovarus or equinus foot, who will receive this procedure as a part of their treatment based on spasticity treatment available guidelines. The results will provide us valuable information like how long cryoneurotomy is effective, before regeneration happens.
Detailed description
Different surgical techniques, including muscle and tendon lengthening and neurotomy/neurectomy (surgical sectioning of a peripheral nerve) are reserved for patients with refractory spasticity.
Cryoneurotomy which involves direct application of a low temperature probe to a nerve is another procedure, which is cheaper, faster and less invasive than surgical intervention, for the treatment of refractory spasticity. While many studies support using of cold temperature in pain relief (Ilfeld BM, 2017, Friedman, T. 2012), there are not much studies on use of cryoneurotomy to manage spasticity.This clinic has been using cryoneurotomy clinically with empiric success for 2.5 years. The initial results reveal significant increased active and passive range of motion in upper limbs and decreased clonus and improved gait after tibial neurotomy in lower limbs.
Spastic equinovarus foot (SEF) which is a common type of lower limb spasticity is typically treated with focal botulinum toxin injections, bracing and therapeutic exercise, although the drawback of these treatments is the need for serial injections and frequent interactions with health care providers. Recently selective tibial neurotomy has been shown to more definitively treat SEF (Bollens B, et al.2011, Deltombe T, et al. 2015), but as mentioned above this is an invasive approach. In light of our promising clinical experience with cryoneurotomy, we propose to prospectively and systematically measure its effect on SEF, as an alternative to more invasive surgical procedures and the typical multi-modal approach.
The data collection fro this project which is a single-centre, prospective cohort study will occur at the Victoria General Hospital (VGH) multidisciplinary spasticity clinic. Patients with spasticity are referred to this clinic for different procedures including cryoneurotomy. This study will not interfere or change the patients' medical care, and the assessments will be done 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.These participants will be invited to have an extra electrophysiological test for being enrolled in this study, which will be performed before the procedure and at 1, 3 and 12 months after cryoneurotomy. In addition, the results of their routine physical examinations including spasticity degree and ankle passive range of motion will be collected in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Procedure: CryoneurotomyA group pf 30 patients with lower limb spasticity who are already candidate for cryoneurotomy will be invited to have an extra electrophysiological test for participation in this study. The test will be done for both limbs for a better comparison. |
| Healthy participants | – | –A group of 30 healthy participants will be invited as a control group, and they will have a single session of electrodiagnostic test for their lower limb in dominant side. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any adult patient with lower limb spasticity who is already candidate for cryoneurotmy as a part of their medical care will be asked to be enrolled in the study.
Key inclusion criteria (8 listed)
- Patients who will have cryoneurotomy as part of their standard treatment for spastic equinovarus foot in VGH spasticity multidisciplinary clinic
- Adults 18-70 years of age (male and female)
- Ability to attend testing sessions, comply with testing protocols and provide written informed consent.
- 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).
- Any healthy participants with the age between 18 to 70. Over 70 will be excluded due to the expected natural alterations in electrophysiological parameters
Key exclusion criteria (2 listed)
- History of previous nerve procedures such as chemical neurolysis with alcohol, cryoneurotomy, any surgery of the tibial nerve.
- Any other neurological pathology different from that responsible for the spasticity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryoneurotomyAlso: nerve cryoablationCryoneurotomy or application of a low temperature probe with guidance of ultrasound which is offered to the patients with lower limbs refractory spasticity as a part of their medical cares. | Procedure or surgery | Patients |
Primary outcome
Any changes in H max to M max amplitude ratio (H/ M ratio)
Time frame: up to 12 months
The ratio of maximum H reflex amplitude to maximum M wave amplitude as another electrophysiological analog for spasticity will be measured by a commercially available clinical electrodiagnosis machine before the procedure and at 1, 3 and 12 months after it. The results will be presented as a ratio and percentage.
Changes in maximum H reflex amplitude
Time frame: up to 12 months after procedure
The maximum H reflex amplitude as an analog of spasticity as it measure excitability of the monosynaptic reflex arc will be assessed by a commercially available clinical electrodiagnosis machine. The assessment will be done before the procedure and at 1, 3 and 12 months after it and at both sides. The measurement unit will be millivolt (mV).
2 secondary outcomes
Degree of changes in ankle dorsi-flexion spasticity as measured by Modified Ashworth Scale (MAS)
Time frame: up to 12 months after procedure
Degree of changes in ankle dorsiflexion range of motion
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Background: PubMed 21305231Bollens B, Deltombe T, Detrembleur C, Gustin T, Stoquart G, Lejeune TM. Effects of selective tibial nerve neurotomy as a treatment for adults presenting with spastic equinovarus foot: a systematic review. J Rehabil Med. 2011 Mar;43(4):277-82. doi: 10.2340/16501977-0786.
- Background: PubMed 25614022Deltombe T, Bleyenheuft C, Gustin T. Comparison between tibial nerve block with anaesthetics and neurotomy in hemiplegic adults with spastic equinovarus foot. Ann Phys Rehabil Med. 2015 Apr;58(2):54-9. doi: 10.1016/j.rehab.2014.12.003. Epub 2015 Jan 9.
- Background: PubMed 23197557Friedman T, Richman D, Adler R. Sonographically guided cryoneurolysis: preliminary experience and clinical outcomes. J Ultrasound Med. 2012 Dec;31(12):2025-34. doi: 10.7863/jum.2012.31.12.2025.
- Background: PubMed 29121277Ilfeld BM, Gabriel RA, Trescot AM. Ultrasound-guided percutaneous cryoneurolysis for treatment of acute pain: could cryoanalgesia replace continuous peripheral nerve blocks? Br J Anaesth. 2017 Oct 1;119(4):703-706. doi: 10.1093/bja/aex142. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Spasticity, 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 8 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any changes in H max to M max amplitude ratio (H/ M ratio) (time frame: up to 12 months). The study lists 2 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 NCT04907201, which also lists 4 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.