Effect of Number of Pulses of Radial Extracorporeal Shock Wave Therapy on Hamstring Spasticity in Children With Cerebral Palsy
Condition: Spasticity, Muscle; Cerebral Palsy; Child; Spastic
MeSH terms: Muscle Spasticity; Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      Cerebral palsy (CP) is a group of permanent disorders affecting movement and postural
      development that are caused by non-progressive disruptions of the brain, usually occurring
      during fetal period or infancy. It is commonly accompanied with sensory disorders and
      learning disability. In 2016, more than 17 million people are affected by CP with a
      prevalence of 1.5 to 2.5 per 1,000 live births. CP remains to be the most common cause of
      severe physical disability in children. The Centres for Disease Control and Prevention (CDC)
      estimated an economic cost of US$4.1 million per CP patient that comprises of medical
      services, special education and productivity loss.

      Current management of spasticity involves physical manipulation such as passive stretching
      and splinting, sometimes combined with oral pharmacologic treatment, intrathecal baclofen
      therapy and botulinum toxin injection. At times, surgical procedures such as Surgical Dorsal
      Rhizotomy (SDR) can also be considered. Botulinum toxin injection has been shown to reduce
      spasticity for up to 6 months, however, the cost of the procedure remains to be an issue in
      developing countries like Indonesia. Therefore, other modality such as a non-invasive therapy
      should be considered as an alternative treatment for spasticity.

      Radial Extracorporeal Shockwave Therapy (rESWT) is a non-invasive treatment that has been
      shown to effectively improve spasticity in patients with spastic motor type CP, despite
      unclear underlying mechanism. According to International Society for Medical Shockwave
      Treatment (ISMST), there has yet to be a recommended guideline for the treatment of
      spasticity in children using rESWT. One crucial physical parameter needed to be determined is
      the number of pulse required to efficiently reduce spasticity. The number of pulse directly
      affects the duration of ESWT per session (the higher the number of pulse given, the longer
      the therapy session). This may be a concern for spastic motor type CP due to accompanying
      sensory and learning disability. Therefore, the objective of this study was to understand
      whether the reduction in hamstring stiffness in children with spastic CP could be influenced
      by the number of pulse in a single ESWT session.
    

Detailed description: 
      This study was designed as a double-blinded and randomized controlled trial.

      Children with spastic CP from the outpatient clinic of the Department of Physical Medicine
      and Rehabilitation at Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo (RSCM)
      participated in the study. The patients were randomly allocated to four groups: 500 pulses,
      1,000 pulses, 1,500 pulses, and 2,000 pulses. All groups undergo routine rehabilitation,
      including physiotherapy. Ethical approval was obtained from the Ethical Committee of Faculty
      of Medicine, University of Indonesia - RSCM.

      Spasticity of hamstring was evaluated as the degree of resistance to passive movement using
      ASAS (0: no spasticity to 4: severe spasticity). Evaluations were done at four time points:
      1) pre-ESWT, 2) immediately post-ESWT, 3) 2 weeks post-ESWT, and 4) 4 weeks post-ESWT. All
      patients were examined by the same physiatrist with the patient lying on supine position on
      the stretcher.

      BTL-6000 SWT Topline (BTL, Czech Republic) was used to apply rESWT on hamstring muscles, with
      the subject lying on prone position. 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, spastic hamstring muscles from CP patients were allocated into four groups - each
      group receiving a varying total number of pulses (group I: 500 pulses, group II: 1,000
      pulses, group III: 1.500 pulses, and group IV: 2,000 pulses). 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 post ESWT, 2 weeks post ESWT, and 4 weeks post ESWT; followed by post-hoc
      Wilcoxon signed-ranked test. Inter-group differences in ASAS reduction were analyzed using
      Kruskal Wallis 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 hamstring muscles, with the subject lying on prone position. No anesthesia was required.
Other intervention name(s): rESWT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spasticity; Cerebral Palsy; Children; ESWT; Pulses