Shockwaves Therapy and Botulinum Toxin for the Treatment of Spasticity in Patients With Cerebral Palsy. A Cross Over RCT

Efficacy of Radial Extracorporeal Shock Waves Compared to Botulinum Toxin Type A in the Treatment of Spasticity of the Lower Extremities in Patients With Cerebral Palsy: a Crossover Randomized Clinical Trial.

Spasticity is a motor disorder that can affect the lower limbs in up to 75% patients with cerebral palsy, having a significantly effect on their mobility and quality of life. There is much controversy about what is the most appropriate treatment of spasticity The objective of the present study is to evaluate the effects of radial extracorporeal shock wave therapy (rESWT) compared to treatment with botulinum toxin to improve spasticity in patients with cerebral palsy

The number needed of patients is 70 (35 per group). Leaving a period of washout between one therapy and the other

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Spasticity
• Intervention / Treatment: Device: shock waves; Drug: Botulinum Toxin Type A

Detailed Description

Outcome Measures:

The primary outcome will be to measure spasticity with passive range of motion of the foot (pROM) by muscular extensibility and its traction reflex using goniometryIt will be assessed at baseline before the treatment, as well as after 3 weeks, 2 months, 3 months, after the washout period (3months), 3 months and 3 weeks, 5 months and 6 months, when the end the intervention.

Secondary outcome includes: 1) Pain will be assessed with Visual Analog Scale (VAS) after the first application of each therapy. 2) Ascertain if the type of Gross Motor Functional Classification System (GMFCS) has an influence on the improvement of these two treatments; 3) Assess whether infiltration of Botulinum Toxin in other muscle groups have influence on the results of study; and 4) Undergo a qualitative registration to know the perception and experience that patient/family will have during this study, through a satisfaction questionnaire.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08320
    • Centro Piloto Arcangel Sant Gabriel. ASPACE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 5 and 55 years
• Any level of GMFCS (Gross Motor Function Classification System)
• The patient consent to participate in the study
• Diagnosis of spastic cerebral palsy
• Triceps Surae spasticity in them.
• The dynamic foot deformity.
• Extensibility between 0 ° and 20 ° in dorsal flexion passive way.
• Do not be diagnosed important cutaneous alterations.

Exclusion Criteria:

• Associate neuromuscular disease.
• Surgical Intervention to augment the balance articulate and / or reduce the spasticity in the last six months.
• Fixed foot deformity.
• Etiology of factors:

or genetic bone disorders / disturbances soft parts. Position with anomalies or alterations in soft parts or bone alterations (mechanical).

• Unable to follow the treatment.
• Allergy to botulinum toxin.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: shock waves; A comparative study with patients with spasticity in gastrocnemius and soleus where a group start having shockwave treatment and receive three sessions at weekly intervals, gastrocnemius and soleus applied in 2000 impacts at a frequency of 8hz and energy intensity is proposed between 2.2-2.4 Bars (0,10-0,12mj ). Swiss dolor clast EMS. The other group will receive botulinum toxin Type A in the same muscles. The dose of toxin is in accordance with the weight of each patient, the dose normally used with each user and always with the same brand is always respected, Botox (4-8-12 U/Kg) Patients will be assessed before treatment, after three weeks, two months and three months after three months when the groups exchange the therapy.	Device: shock waves; Swiss dolorclast smart EMS Registration: EN-60601-1 Type BF IP40. 93/42 CEE
Active Comparator: botulinum toxin; A comparative study with patients with spasticity in gastrocnemius and soleus where a group start having shockwave treatment and receive three sessions at weekly intervals, gastrocnemius and soleus applied in 2000 impacts at a frequency of 8hz and energy intensity is proposed between 2.2-2.4 Bars (0,10-0,12mj ). Swiss dolor clast EMS.The other group will receive botulinum toxin type A in the same muscles. The dose of toxin is in accordance with the weight of each patient, the dose normally used with each user and always with the same brand is always respected. Botox (4-8-12 U/Kg)Patients will be assessed before treatment, after three weeks, two months and three months after three months when the groups exchange the therapy.	Drug: Botulinum Toxin Type A; Botulinum toxin type A Botox; Other Names: Type A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
muscle elongation of spastic muscle will be evaluated using composite measure of muscular extensibility and their traction reflex with goniometry	up to three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the patients perceive pain	It shall be assessed by visual analog scale	after each therapy
Ascertain if the type of GMFCS has an influence on the improvement of these two treatments. Qualitative registation to achieve the percepcion and experience that have made the treatment received the patient/family.		at the end to study
To undergo a qualitative registration to know the perception and experience that patient/family will have during this study		at the end to study

Collaborators and Investigators

• Sponsor: Xavi Vidal Novellas
• Collaborators: Cerebral Palsy Association
• Investigators: Principal Investigator: Vidal Novellas, Aspace. Association of Cerebral Palsy

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: March 6, 2015
• First Submitted That Met QC Criteria: March 26, 2015
• First Posted (Estimate): March 27, 2015

Study Record Updates

• Last Update Posted (Actual): March 13, 2017
• Last Update Submitted That Met QC Criteria: March 9, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Physiotherapy; Botulinum toxin; shockwaves
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Cerebral Palsy; Muscle Spasticity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: Neuroshockwaves

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes