NCT05702606

Shock Wave Therapy for Management of Spasticity in Patients With Cerebral Palsy

Completed NA Last updated 27 January 2023

What this trial tests

NA trial testing Radial extracorporeal shock wave therapy (rESWT) in Cerebral Palsy in 73 participants. Completed in 3 October 2022.

Timeline

10 June 2021

Primary endpoint
3 October 2022

3 October 2022

Quick facts

Lead sponsor	Fundacio Aspace Catalunya
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	73
Start date	10 June 2021
Primary completion	3 October 2022
Estimated completion	3 October 2022
Sites	1 location across Spain

Drugs / interventions tested

• Radial extracorporeal shock wave therapy (rESWT)

Conditions studied

• Cerebral Palsy — all drugs for Cerebral Palsy →
• Spasticity, Muscle — all drugs for Spasticity, Muscle →
• Extracorporeal Shock Wave Therapy — all drugs for Extracorporeal Shock Wave Therapy →

Sponsor

Fundacio Aspace Catalunya

Who can join

Adults 4 to 50, any sex, with Cerebral Palsy or Spasticity, Muscle. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Spasticity is the most common motor disorder in cerebral palsy (CP). The objectives of his therapeutic approach include; reducing pain, ease of use of orthopedic aids, improving posture, minimizing contractures and deformity, and facilitating mobility and dexterity, with the ultimate goal of maximizing the potential of the patient and promoting their independence and quality of life. The approach to spasticity in CP is complex and presents itself as a great challenge for the rehabilitation team. Radial extracorporeal shock wave therapy (rESWT) has been established in recent years as an effective, non-invasive alternative with hardly any side effects (small bruises or discomfort during the application) for the management of spasticity in patients with CP. rESWT is a relatively new therapy in the field of neurology, in 2010 was published the first clinical trial where shock waves were applied for the management of spasticity in patients with CP. Currently, few works have studied the efficacy of rESWT in patients with CP. In all of them, the results demonstrated the treatment's effectiveness in reducing spasticity locally in people with CP up to 3 months after the application. The group most studied muscle has been the Triceps Surae, and there is a great disparity regarding the doses of treatment applied in each study, especially regarding the number of sessions and the time interval between sessions. The most widely used protocol is 3 rESWT sessions with a time interval of 1 week between session; This protocol was established as the most effective in the treatment of trauma pathology. Despite all the variability in the administration of the dose, we have been able to observe that none of them has studied the effect of rESWT by lengthening the time interval between sessions beyond one week to check whether the therapeutic effects on spasticity can be prolonged over time by applying the same dose. Most of the studies conclude that future research should be aimed at studying the most optimal dose of treatment as well as evaluating the long-term results.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Radial extracorporeal shock wave therapy for the management of spasticity in cerebral palsy: study protocol for a randomized controlled trial.
   Tur Segura M, Gimeno Esteve F, Biedermann Villagra T, Jiménez Redondo J, et al · · 2024 · PMID 38957349 · DOI 10.3389/fneur.2024.1402452