NCT04670783

Surgery and Neuroablative Procedures in Spasticity

Measuring the Efficacy of Surgical and Percutaneous Neuroablative Procedures in the Management of Plateaued or Refractory Upper-extremity Spasticity.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 63 (actual)
• Sponsor: Vancouver Island Health Authority · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

For many patients with spasticity, traditional therapies have not achieved maximal outcomes. Due to common complaints such as pain, limb positioning and hygiene concerns, there has been an increase demand for other adjunctive therapies like surgeries and other interventions. This spasticity multidisciplinary clinic consisting of a physiatrist, plastic surgeon and anesthesiologist is performing a novel approach to refractory spasticity to triage and designed a treatment plan for them as routine medical care. This study will document the efficacy of this novel designed multidisciplinary approaches for intervention in complex spasticity patients, and will develop a decision-making algorithm in spasticity including both traditional treatment (i.e. botulinum toxin , bracing) and novel treatments(i.e. neurectomy , cryoneurotomy).

Detailed description

Many patients continue to live with disabling spasticity that negatively affects their health, independence and quality of life. For these patients, traditional therapies such as bracing, medications, and botulinum toxin have not achieved maximal outcomes. Up to one-quarter of physicians have noted to be limited by the maximal dosage of botulinum toxin allowed in their country. Due to common complaints of pain, difficulty with limb positioning, and hygiene concerns there has been an increase in demand for novel adjunctive therapies, including surgery, to improve patient outcomes. The deisgned triage pathway is based on the diagnostic lidocaine nerve block (DNB), which is already using in Franco-European studies and has been accepted as academic abstract at the Canadian Association of Physical Medicine and Rehabilitation Annual Meeting in Gatineau Quebec in 2019. In this approach, patients are triaged for intervention based on their responses to DNB, which is applying local anesthesia to a selected nerve branch. Also the investigators of this study who have created Canada's first interdisciplinary spasticity clinic consisting of a physiatrist, plastic surgeon and anesthesiologist are working to bring the world-leading spasticity interventions to Canada and developing Canadian techniques. This includes cryoneurotomy and selective microfascicular neurectomy. Both of these techniques have been developed in this multidisciplinary clinic and in the past three years and have been published as journal articles, academic posters or presented at international congresses.This research is a pilot study to test the present current triage and treatment pathways. This study will evaluate the patients with upper limb spasticity who are going to have any of traditional treatments (i.e. bracing, botulinum toxin) or novel treatments (i.e. cryoneurotomy, tenotomy, neurotomy) as their standard medical cares. All these assessments are parts of their standard evaluations and the available data will be collected for this study. These data include their range of motions, spasticity grades, upper limb function, pain, satisfaction and injected botulinum toxin dosage. These data will be used to document the efficacy of this approach by comparing these measurements that are already done for their standard clinical care. Also, the final result will be helpful to create a Canadian algorithm to approach patients with refractory upper limb spasticity.

Conditions

• Upper Extermity Spasticity
• Multidisciplinary Approach
• Novel Algorithm
• Diagnostic Nerve Block
• Surgery
• Percutaneous Neuroablative Procedures
• Refractory Spasticity

Interventions

Type	Name	Description
PROCEDURE	Surgery	Orthopedic surgery (i.e. tenotomy, tendon transfer) or percutaneous neuroablative procedures (i.e. cryoneurotomy) which will be done for upper limb refractory spasticity after being triaged by DNB.

Timeline

• Start date: 2020-09-15
• Primary completion: 2023-05-30
• Completion: 2023-05-30
• First posted: 2020-12-17
• Last updated: 2023-06-05

Locations

1 site across 1 country: Canada