Radial Extracorporeal Shock Wave Therapy for Spastic Plantar Flexor Muscles in Young Children With Cerebral Palsy
Condition: Muscle Spasticity; Cerebral Palsy
MeSH terms: Muscle Spasticity; Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether radial extracorporeal shock wave therapy in
      combination with traditional physical therapy is safe and effective for the management of
      spastic plantar flexor muscles in patients with cerebral palsy younger than averaged three
      years of age.
    

Detailed description: 
      Cerebral palsy (CP) is a clinical syndrome characterized by a persistent disorder of posture
      or movement caused by a non-progressive disorder of the immature brain. The prevalence of CP
      has been reported to be between 1.86 cases per 1,000 population in the United Kingdom and 3.6
      cases per 1,000 in 8-year-old children in the United States, with little variation among
      Western nations. In a very recent systematic review analyzing a total of 49 studies, the
      pooled overall prevalence of CP was 2.11 cases per 1,000 live births. Rates of CP in
      population-based settings in India and China gave figures of 2-2.8 cases per 1,000 births. A
      systematic literature review for a period spanning between 1965 and 2004 found CP more
      prevalent in more deprived socio-economic populations. The same study identified low
      birthweight, intrauterine infections and multiple gestation as the most important risk
      factors for CP.

      Most children with CP suffer from spasticity as the main motor disorder. Spasticity is a
      major challenge for rehabilitation of children with CP. This is because spasticity can cause
      pain, prevent or hamper function and may disturb sleep. Spasticity of plantar flexor muscles
      is a particular problem in CP because it causes toe walking. This can result in major
      functional implications such as disturbances in balance and walking, and interfere with gross
      motor function.

      The management of spasticity in CP is complex and is a major challenge to the treatment team.
      The ultimate goal of any therapy program must be to achieve the child's maximum potential in
      motor skills. Unfortunately, the scientific evidence for various physical therapy treatment
      options for children with CP is limited. Botulinum neurotoxin (BoNT) is a widely used and
      effective pharmacological treatment for focal muscle over-activity. An alternative to BoNT
      treatment is focal intramuscular treatment with phenol and alcohol, with the aim to improve
      activity limitations and other outcomes in children and adults with spasticity. However,
      focal intramuscular injection of BoNT, phenol and alcohol is not without problems: (i) BoNT
      is expensive and not available in many countries; (ii) a significant risk of focal
      intramuscular injection of alcohol and phenol is persisting pain; and (iii) all these
      procedures are invasive and, thus, not without risk when applied under difficult hygienic
      conditions. With regard to post-stroke spasticity, a recent Cochrane review concluded that,
      at best, there was 'low level' evidence for the effectiveness of outpatient multidisciplinary
      rehabilitation in improving active function and impairments following BoNT treatment for
      upper limb spasticity in adults with chronic stroke.

      Orthopedic surgery is considered a last resort in managing spasticity in children with CP,
      but is not an option for managing spasticity per se. Instead, it is used to help correct the
      secondary problems that occur with growth alongside spastic muscles and poor motion control.
      Those problems include muscle shortening, joints contractures and bony deformities.

      Recently, extracorporeal shock wave therapy (ESWT) has become an alternative in the treatment
      of spasticity. A byproduct of extracorporeal shock wave lithotripsy, ESWT has emerged as a
      noninvasive management option for tendon and other pathologies of the musculoskeletal system
      with minimal unwanted side effects such as temporary skin redness and pain during treatment.
      Prior studies on tendinopathy showed that ESWT can be as or more effective than other forms
      of treatment such as eccentric exercise, traditional physiotherapy, steroid injections and
      surgery. There are two different types of extracorporeal shock waves - focused (fESWT) and
      radial (rESWT) - and several modes of operation of focused and radial extracorporeal shock
      wave generators.

      Among the studies on fESWT and rESWT for spasticity performed so far, six out of 18 (33%)
      were pilot studies without control group, seven (39%) were pseudo-controlled studies (i.e.,
      each patient served as her/his own control, with one placebo treatment followed by one ESWT
      treatment one or two weeks later), and five (28%) were randomized controlled trials (RCTs).

      It is of note that none of these studies on fESWT and rESWT for spasticity were performed on
      patients younger than an average of 4.8 years of age. However, it has been argued that the
      management of spasticity in children with CP should be started as early as possible, and
      there is evidence that early intervention (i.e., before the age of 36 months) can minimize
      secondary complications of CP.

      Acknowledging (i) the particular problem of spastic plantar flexor muscles in CP, (ii) the
      limited scientific evidence for various physical therapy treatment options for children with
      CP, (iii) the risks and limitations associated with BoNT and focal intramuscular treatment
      with phenol and alcohol, and (iv) the proven effectiveness of rESWT in the treatment of
      spasticity in patients with CP aged between 10 and 46 years of age, the aim of the present
      study is to determine whether rESWT in combination with traditional conservative therapy is
      safe and effective for the management of spastic plantar flexor muscles in patients with CP
      younger than averaged three years of age.
    

Intervention name(s): Swiss DolorClast; Traditional conservative therapy
Intervention type(s): Device; Procedure
Intervention description(s): "Radial" (blue) handpiece; one rESWT session per week for three months, with 1500 radial shock waves per session and leg, i.e., a total of 3000 radial shock waves per session or a total of 36.000 radial shock waves within twelve weeks; radial shock waves evenly distributed over the gastrocnemius and soleus muscles; air pressure of the device set at 0.6 bar, resulting in a positive energy flux density (EFD+) of 0.03 mJ/mm2; radial shock waves applied at a frequency of 8 Hz; local or general anesthesia not applied.; Physical therapy, Chinese massage, meridian mediation and muscle stimulation for three months (six days per week, 30 min per type of therapy).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Children; Spasticity; Extracorporeal shock wave therapy; Cerebral palsy; Gross motor function