NCT04670783

Surgery and Neuroablative Procedures in Spasticity

Completed Last updated 5 June 2023

What this trial tests

trial testing Surgery in Upper Extermity Spasticity in 63 participants. Completed in 30 May 2023.

Timeline

15 September 2020

Primary endpoint
30 May 2023

30 May 2023

Quick facts

Lead sponsor	Vancouver Island Health Authority
Status	Completed
Study type	OBSERVATIONAL
Enrollment	63
Start date	15 September 2020
Primary completion	30 May 2023
Estimated completion	30 May 2023
Sites	1 location across Canada

Drugs / interventions tested

• Surgery

Conditions studied

• Upper Extermity Spasticity — all drugs for Upper Extermity Spasticity →
• Multidisciplinary Approach — all drugs for Multidisciplinary Approach →
• Novel Algorithm — all drugs for Novel Algorithm →
• Diagnostic Nerve Block — all drugs for Diagnostic Nerve Block →

Sponsor

Vancouver Island Health Authority — full company profile →

Who can join

Adults 18 to 70, any sex, with Upper Extermity Spasticity or Multidisciplinary Approach. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Measuring the Efficacy of Percutaneous Cryoneurolysis in Participants With Refractory or Plateaued Shoulder, Elbow, Wrist, or Finger Spasticity.
   Hashemi M, MacRae F, Boissonnault È, Vincent D, et al · · 2025 · cited 5× · PMID 40148263 · DOI 10.1097/phm.0000000000002728
2. Percutaneous Cryoneurolysis for Upper Limb Spasticity: A Systematic Scoping Review of Current Evidence, Safety Profile, and Implications for Hand and Upper Extremity Practice.
   Passiatore M, Bissolotti LM, Starnoni M, Pecori L, et al · · 2026 · PMID 42123279 · DOI 10.3390/jcm15093541
3. Exploratory Use of Proximal Cryoneurolysis and Distal Botulinum Toxin Type A for Upper-Limb Spasticity: A Case Report with Scoping Review.
   Luigi DL, Bruno M, Maria FA, Francesco F, et al · · 2026 · PMID 41745732 · DOI 10.3390/toxins18020066