Effect of Session Frequency of rESWT on Gastrocnemius Muscle Spasticity in Children With Spastic Type Cerebral Palsy
Condition: Spasticity, Muscle; Cerebral Palsy; Child; Spastic
MeSH terms: Muscle Spasticity; Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      Spasticity, defined as a velocity dependent increase in tonic stretch reflexes, is one of the
      most prominent motor problems that occur in patients with cerebral palsy (CP). This causes
      difficulty in achieving balance, mobility, and an upright stance. CP is a group of permanent
      disorders that affect the development of movement and posture caused by a non-progressive
      damage to the brain. Because CP occurs in 2-3 of 1000 individuals, it is one of the most
      common causes of severe physical disability in children.

      Mismanagement of spasticity can lead to contracture which is extremely difficult to treat and
      may result in severe functional disabilities. The current management of spasticity in CP
      includes physical therapy (i.e. passive stretching), oral medication, botulinum toxin
      injection, and surgery. Botulinum toxin injection has been proven to effectively reduce
      spasticity yet many patients are unable to get access to this treatment due to its high cost.
      Moreover, Botulinum toxin injection is currently not covered by the public health insurance
      of Indonesia. Therefore, other modalities which are more affordable and are non-invasive
      therapies should be considered as a treatment option for spasticity.

      Radial Extracorporeal Shockwave Therapy (rESWT) has been utilized in the medical practice for
      the treatment of several musculoskeletal disorders such as chronic tendinopathies and
      spasticity. It is hypothesized that ESWT has two main effects which include a direct effect
      from mechanical forces at the treatment point and an indirect effect from cavitation. Even
      though rESWT has less penetration capacity over the focused Extracorporeal Shockwave Therapy
      (fESWT), rESWT is still believed to be more superior to fESWT because it requires less
      precise focusing, is less painful, and costs less. These also make rESWT the more appropriate
      choice for children with CP.

      Many studies have proven the efficacy of ESWT in reducing spasticity in spastic CP patients
      with significantly long lasting effects. Despite promising results, there still has yet to be
      a recommended guideline for the treatment of spasticity in children using rESWT. One of the
      critical parameters needed to be determined is the frequency of treatment. Therefore, the
      objective of this study is to understand whether the reduction in gastrocnemius stiffness in
      children with spastic CP is influenced by the frequency of ESWT sessions.
    

Detailed description: 
      This study was designed as a double-blinded and randomized controlled trial.

      Pediatric CP patients from the Department of Physical Medicine and Rehabilitation at Rumah
      Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo (RSCM) are involved in this research.
      Participants were selected using the inclusion criteria as follow: 1) children with spastic
      CP who are 5 - 18 years old, 2) one or two gastrocnemius muscle with an Australian Spasticity
      Assessment Scale (ASAS) of two or more, 3) at least 6 months since the last botulinum
      injection on gastrocnemius, 4) no surgical operation on lower limb within the last 12 months,
      5) absence of severe contracture on gastrocnemius, and 6) ability of legal caregiver to
      provide written informed consent.

      The spasticity of gastrocnemius was evaluated using ASAS (0: no spasticity to 4: severe
      spasticity). Data were collected at nine time points: 1) pre-ESWT, 2-6) immediately after
      each ESWT session, 7) 4 weeks after the last (fifth) ESWT session, 8) 8 weeks after the last
      (fifth) ESWT session, and 9) 12 weeks after the last (fifth) ESWT session. All patients were
      examined by the same physiatrist who was blinded to the protocol (i.e. not informed about the
      study and the group allocation) throughout the whole study.

      The investigators used a BTL-6000 SWT Topline (BTL, Czech Republic) to apply rESWT on
      gastrocnemius muscles. For the procedures, a 1.2 cm probe was used. A total of 1,500 pulses
      were delivered to each gastrocnemius muscle. The energy flux density was constant at 0.1
      mJ/mm2 and the repetition frequency was at 4 Hz, with a pressure of 1.5 bars.

      For double-blinded treatment, 28 different spastic gastrocnemius muscles from 14 CP patients
      were allocated into two groups. Both groups had a true or sham ESWT for five consecutive
      weekly treatments. Group I received five true ESWT sessions. Group II received three true
      ESWT in session 1, 3 and 5 and two sham ESWTs in session 2 and 4. No anesthesia was given.
      Adverse events were closely monitored during and after therapy.

      Intra-group changes in ASAS were evaluated with Friedman analysis of variance from baseline,
      immediately after each ESWT, 4 weeks after last (fifth) ESWT, 8 weeks after last (fifth) ESWT
      and 12 weeks after last (fifth) ESWT; followed by post-hoc Wilcoxon signed-ranked test.
      Inter-group differences in ASAS reduction were analyzed using Mann-Whitney U- test.
      Statistical analysis was conducted using SPSS ver. 23.0 (IBM Corporation, Armonk, NY, USA).
      The level of significance was set at <0.05.
    

Intervention name(s): radial Extracorporeal Shockwave Therapy
Intervention type(s): Device
Intervention description(s): rESWT was given on gastrocnemius muscles with the subject lying on prone position. No anesthesia was required.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spasticity; Cerebral Palsy; Children; ESWT; Frequency