413

NeuroRehabilitation 29 (2011) 413419

DOI 10.3233/NRE-2011-0720
IOS Press

Radial extracorporeal shock wave therapy

(rESWT) in the treatment of spasticity in
cerebral palsy: A randomized,
placebo-controlled clinical trial
Xavier Vidala,b, , Antonio Morralb , Llus Costab and Miriam Tura
a

Cerebral Palsy Association (ASPACE), Centre Pilot Arc`angel Sant Gabriel, Barcelona, Spain
Blanquerna School of Health Science, Universitat Ramon Llull, Barcelona, Spain

Abstract. Aim: The aim of this study was to evaluate the efficacy and safety of radial extracorporeal shock wave therapy (rESWT)
in the treatment of spasticity in patients with cerebral palsy.
Methods: Fifteen patients with spastic cerebral palsy, 12 men and 3 women, aged 1046 years (mean age 31). The 15 patients
presented 40 spastic muscles that were divided in three groups using a computerized random-number generator. The first group,
received rESWT in spastic muscle. The second group received rESWT in spastic muscle + rESWT in antagonist muscle. The third
group received placebo. Range of motion and Ashworth Scale were performed. This study is a randomized, placebo-controlled
clinical trial. The patients were treated in 3 sessions at intervals of one week.
Results: There are significant differences between groups treated with rESWT and group placebo. A significant decrease in the
Ashworth Scale, an increase in the range of motion, were observed in all patients that were treated with rESWT. Positive results
were maintained for at least 2 months after treatment.
Interpretation: The treatment with rESWT is more effective than placebo in decreasing spasticity of patients with CP.
Keywords: Cerebral palsy, spasticity, extracorporeal shock wave therapy, hypertonia, muscle tone

1. Introduction
Cerebral palsy (CP) describes a group of permanent
disorders of the development of movement and posture,
causing activity limitation, that are attributed to non
progressive disturbances that occurred in the developing fetal or infant brain. The motor disorders of cerebral
palsy are often accompanied by disturbances of sensation, perception, cognition, communication, and behavior, by epilepsy, and by secondary musculoskeletal
problems [1]. CP affects between 1.5 and 2.5 per 1000
live births and is thought to be the most common cause
of severe physical disability in childhood [2,3]. The
Corresponding author: Xavier Vidal Novellas, C/Sep
ulveda 44,
5`e 1a , 08015 Barcelona, Spain. E-mail: JavierVN@blanquerna.url.
edu.

spastic motor type is the most common form of CP [4].

Spasticity is a motor disorder characterized by a velocity dependent increase in tonic stretch reflexes (muscular tone) with exaggerated tendon jerks, resulting from
hyperexcitability of the stretch reflex [5]. The sustained
contraction of the spastic muscle groups, will result in
permanent contractures and skeletal deformities, that
cause the limitation of patient activity [6] Therefore,
treatment of spasticity plays an important role in the
management of patients with CP. Conventional treatment of spasticity may include passive stretching [7,8],
serial plastering [9,10], splints [11,12], pharmacologic
treatment [1316], and botulinum toxin [1721] Despite all the existing treatments, we believe that shock
wave therapy, being a non-invasive therapy may be an
interesting alternative in the treatment of spasticity.

ISSN 1053-8135/11/$27.50 2011 IOS Press and the authors. All rights reserved

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X. Vidal et al. / Shock wave therapy in CP

Fig. 1. Upper limb muscles. Median improvement 2 months receiving treatment There are significant differences between group agonist and
group placebo.

Shock waves are a sequence of acoustic pulse, with

a high peak pressure (100 MPa), and a short life cycle
(10 ms). The therapeutic effect of radial shock waves
occurs a few centimeters deep to the skin surface (0 to
3.5 cm) [22] Different studies have demonstrated the
efficacy of shock waves in treating pathologies of the
musculoskeletal system such as chronic tendinopathies
or hypertrophic pseudoarthrosis [2332]. Two recent
studies have also demonstrated the effectiveness of
shock waves in the treatment of spasticity. In the first
of these studies, hypertonia reduction of the wrist and
fingers muscles was observed, in patients affected by
stroke [33]; in the second, a significant long-lasting
reduction in hypertonia in the plantar flexors in children with CP was reported [34]. These studies suggest
that spasticity can be reduced after application of shock
waves. In April 2008, in the absence of literature in
the field of CP we conducted an evaluation with three
patients of ASPACE Barcelona, to which we applied
shock waves in the muscle groups that were more spastic, mainly antigravity muscles, biceps brachii in the
upper limbs, and in the lower limbs, sural triceps. The
clinical results were a reduction of spasticity immediately after application and improvement of extensibility, results were maintained for a month which is the
time of the first contact with this technique. After presenting these data at the world shock wave congress
held in Monaco in June of 2008 and see the great impact it has caused, we decided to start this study in
October 2008. We aim to evaluate in a randomized,

placebo-controlled clinical trial, the efficacy and safety

of radial extracorporeal shock wave therapy (rESWT)
in the treatment of spasticity in patients with CP.

2. Methods
2.1. Subjects
Fifteen patients participated in the study. We evaluated 12 men and 3 women, aged between 1046 years
(mean age 31). Patients were recruited in ASPACE
Barcelona, using the following inclusion criteria: Patients with spastic CP. Time gap of at least 9 months
since the last botulinum toxin injection. Ability of subject or legal respondent to give written informed consent after being told of the potential benefits and risks of
participating in the study. The 15 patients presented 40
spastic muscles. Distribution: 6 biceps brachii, 6 wrist
flexors, 5 hip adductors, 10 gastrocnemius, 10 soleus
and 3 hamstrings. This clinical trial has been approved
by the ethics committee of the Ramon Llull University.
All patients provided informed written consent.
2.2. Evaluation protocol
At each clinical visit, range of motion and Ashworth
Scale were performed.

X. Vidal et al. / Shock wave therapy in CP

415

Fig. 2. Lower limb muscles. Median improvement 2 months after receiving treatment There are significant differences between group agonist
and group placebo.

2.3. Clinical examination

2.5. Shock wave instrumentation and treatment

Spasticity was evaluated in the lower limbs by passive range of motion with a goniometer, and in the upper limbs with Ashworth scale (0: no spasticity to 4:
severe spasticity). Patients were examined by the same
physiotherapist, who was blindfolded. One visit was
performed on each occasion, by the same physiotherapist. The examination was performed with the patient
lying on the stretcher.

Swiss Dolor Clast (EMS-Switzerland). The patients

were treated in 3 sessions at intervals of one week.
Number of impulses: 2000 in each spastic muscle in
group I and 4000 in group II (2000 in spastic muscle
and 2000 in antagonist muscle). Energy flux density:
0.10 mJ/mm2. (2 bar). Frequency: 8 Hz.

2.4. Study procedure

There are not significant differences between group

I (rESWT in spastic muscle) and group II (rESWT in
spastic muscle + rESWT in antagonist muscle). On
the spastic muscles from upper limbs there are significant differences (p = 0.05) between group I (rESWT
in spastic muscle) and group III (placebo), (Fig. 3). On
the spastic muscles of lower limbs there are significant
differences (p = 0.044) between group I (rESWT) and
group III (placebo), (Fig. 4). On the spastic muscles
of lower limbs there are significant differences (p =
0.043) between group II (rESWT in spastic muscle +
rESWT in antagonist muscle) and group III (placebo).
A significant decrease in the Ashworth Scale, an increase in the range of motion, were observed in all
patients that were treated with rESWT. Observed side

This study is a randomized, placebo-controlled clinical trial. In each subject, the evaluation was performed
immediately before application and after one, two and
three months of treatment. The non-parametric MannWhitney U test for independent samples was used for
statistical analyses. The 40 spastic muscles were divided in three groups using a computerized randomnumber generator. Group I (14 muscles): received
rESWT in spastic muscle. Group II (13 muscles): received rESWT in spastic muscle 4+ rESWT in antagonist muscle. Group III (13 muscles): received placebo
via application of a sham rESWT with sound in spastic
muscle (see Figs 1 and 2).

3. Results

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X. Vidal et al. / Shock wave therapy in CP

Fig. 3. Comparison of median improvement between the first and third month after treatment in upper limb muscles.

Fig. 4. Comparison of median improvement between the first and third month after treatment in lower limb muscles.

X. Vidal et al. / Shock wave therapy in CP

417

Fig. 5. rESWT application in gastrocnemius.

Fig. 6. rESWT application in wrist flexors.

effects were 3 small superficial hematomas, petechiae,

and light pain during the therapy expressed by 3 patients. All side effects were tolerated by all the patients
and disappeared after 17 days.
4. Discussion
This study presents interesting ideas about the usefulness of rESWT in the treatment of spasticity in cerebral palsy patients, as a noninvasive technique, usually
painless and without important side effects. Obtained
clinical results were interesting, thus in the active stim-

ulation group a significant reduction in muscle tone after treatment with rESWT was detected, however, in the
placebo group no effect was observed. Positive results
were maintained for at least 2 months after treatment
and at three months the results were the same as those
obtained just before treatment. All the patients finished
the study. At the end of follow-up, they were asked
about willingness repeat the experience and all of them
answered affirmatively. The mechanism of shock wave
therapy on spastic muscles is still unknown. Basic research and further large randomized controlled studies
are necessary to support the results of this clinical trial.

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X. Vidal et al. / Shock wave therapy in CP

5. Conclusion
This experimental study shows that the treatment
with rESWT is more effective than placebo in decreasing spasticity of patients with CP,with an effect that is
maintained up to two months later. At three months,
it loses its effectiveness (Figs 5, 6); therefore, it would
be interesting to do another rESWT application before
three months.

Acknowledgments
We would like to acknowledge to Medical Direction
of ASPACE, Dra Anna Fornos and Dra Francisca Gimeno for their support in this clinical trial. Also Ms
Elisabet Carlota for their participation.

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