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

Xavi Vidal Novellas70 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 5 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

muscle elongation of spastic muscle will be evaluated using composite measure of muscular extensibility and their traction reflex with goniometry

Time frame: up to three months

Secondary Outcomes

Evaluate the patients perceive pain

It shall be assessed by visual analog scale

Time frame: 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.

Time frame: at the end to study

To undergo a qualitative registration to know the perception and experience that patient/family will have during this study