Effectiveness of Shock Wave Therapy for Upper Limb Spasticity

Effectiveness of Shock Wave Therapy to Treat Upper Limb Spasticity in Hemiparetic Patients

Introduction: Shock wave therapy (SWT) has a potential interest to treat spasticity. However, the pathophysiology of this treatment remains unknown. Some authors assert that it is effective on spasticity itself, while others suggest that it acts more on fibrosis.

Method: this study will assess the effectiveness of radial SWT to treat wrist and finger flexors stiffness in stroke patients, comparing subacute spastic patients (< 12 months) with chronic patients presenting muscle contractures (> 12 months). Forty-eight stroke patients (24 in the subacute phase and 24 in the chronic phase) will be included. One real and one sham sessions of SWT will be performed with a 2-week interval. The order of the sessions will be randomized. Motor control, stiffness and spasticity will be assessed with clinical and objective measures, just after and just before each session, by a blind assessor. The targeted muscles will be flexor carpi radialis, flexor carpi ulnaris and flexor digitorum profundus, and will be the same for the two session.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: shock wave therapy

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gaëtan Stoquart, MD PhD; Phone Number: +3227641650; Email: gaetan.stoquart@uclouvain.be
• Study Contact Backup: Name: Clara Selves, MD; Phone Number: +3227641650; Email: clara.selves@uclouvain.be

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires Saint-Luc
    • Contact: Gaëtan Stoquart, MD PhD; Phone Number: +327641650; Email: gaetan.stoquart@uclouvain.be
    • Contact: Clara Selves, MD; Phone Number: +327641650; Email: clara.selves@uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• History of cerebral lesion
• Wrist spasticity ≥ 1+/4 on the Modified Ashworth Scale
• Wrist spasticity ≥ 2/4 on the Tardieu Scale
• Passive dorsal extension of the wrist ≥ 10°

Exclusion Criteria:

• Botulinum toxin injection in the upper limb in the past three months
• History of wrist arthrodesis
• Myopathy
• Treatment with oral anticoagulants or coagulation disease
• Tumor or infection of the paretic upper limb

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: interventional group; group receiving shock wave therapy	Device: shock wave therapy; Shockwave therapy is a non-invasive treatment creating a series of low energy acoustic wave pulsations that are directly applied through the skin via a gel medium
Sham Comparator: control group; sham shock wave therapy	Device: shock wave therapy; Shockwave therapy is a non-invasive treatment creating a series of low energy acoustic wave pulsations that are directly applied through the skin via a gel medium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Ashworth Scale	Clinical assessment of spasticity for wrist and fingers flexors, score from 0 to 4 (a higher score representing a greater spasticity)	Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Tardieu scale	Clinical assessment of spasticity for wrist and fingers flexors; score from 0 to 4 (a higher score representing a greater spasticity)	Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
objective measure of elastic and viscous stiffness of the wrist, expressed in N.m.rad	electronic oscillatory device for stiffness measurement	Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT)
objective measure of muscle stiffness	Myoton measurement device	Before (baseline) and 10 minutes (post-treatment) after each of the two sessions (sham or real SWT)
manual goniometer	Passive measure of joint range of motion	Before (baseline) and 10 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Medical Research Council muscle testing	strength assessment; score from 0 to 5 (a higher score representing a greater strength)	Before (baseline) and 25 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Isokinetic dynamometer	objective measure of muscle stiffness at the wrist	Before (baseline) and 15 minutes (post-treatment) after each of the two sessions (sham or real SWT)
H reflex	electrophysiological assessment of the H reflex (motoneuronal excitability)	Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Box and block test	measure of manual ability	Before (baseline) and 30 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Fugl Meyer Assessment - computerized adaptive testing	neurological impairment	Before (baseline) and 25 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Abilhand scale	PROMS on bimanual activities; a higher score represents a better manual ability	Before (baseline) and 45 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Wolff Motor Function Test	manual activities	Before (baseline) and 35 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Visual Analog Scale	patient self-assessment of overall effectiveness of SWT; score from 0 to 4 (a higher score representing a greater improvement)	Before (baseline) and 45 minutes (post-treatment) after each of the two sessions (sham or real SWT)

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Principal Investigator: Gaetan Stoquart, MD, PhD, Cliniques Universitaires Saint-Luc

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2019
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: March 18, 2020
• First Posted (Actual): March 20, 2020

Study Record Updates

• Last Update Posted (Estimate): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity
• Other Study ID Numbers: 2019/27MAR/151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No