Clinical trial NCT04907201: H-reflex in Spastic Lower Limb Cryoneurotomy
Official title: Electrophysiological Assessment of Cryoneurotomy in Spastic Lower Limbs.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Muscle Spasticity
Keywords: spasticity
Lower limb
H reflex
Cryoneurotomy
Range of motion
Lead sponsor: Vancouver Island Health Authority
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria for patient group:

1. Patients who will have cryoneurotomy as part of their standard treatment for spastic equinovarus foot in VGH spasticity multidisciplinary clinic
2. Adults 18-70 years of age (male and female)
3. Ability to attend testing sessions, comply with testing protocols and provide written informed consent.
4. 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).

Inclusion Criteria for healthy participants:

1. Any healthy participants with the age between 18 to 70. Over 70 will be excluded due to the expected natural alterations in electrophysiological parameters
2. Able to attend and comply with the testing protocols
3. Able to provide informed written consent
4. Able to understand and speak English or have access to an appropriate interpreter

Exclusion Criteria:

1. History of previous nerve procedures such as chemical neurolysis with alcohol, cryoneurotomy, any surgery of the tibial nerve.
2. Any other neurological pathology different from that responsible for the spasticity.

Primary outcomes:
measure: Any changes in H max to M max amplitude ratio (H/ M ratio)
timeFrame: up to 12 months
measure: Changes in maximum H reflex amplitude
timeFrame: up to 12 months after procedure
Secondary outcomes:
measure: Degree of changes in ankle dorsi-flexion spasticity as measured by Modified Ashworth Scale (MAS)
timeFrame: up to 12 months after procedure
measure: Degree of changes in ankle dorsiflexion range of motion
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: Victoria General Hospital
state: British Columbia
Study officials:
References:
citation: 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.
citation: Deltombe 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.
citation: Friedman 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.
citation: Ilfeld 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.