Effect of Number of Pulses of Radial Extracorporeal Shock Wave Therapy on Hamstring Spasticity in Children With Cerebral Palsy

September 4, 2020 updated by: Rizky Kusuma Wardhani

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Universitas Indonesia Fakultas Kedokteran

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with spastic CP aged 5 to 18 years old
  • at least one hamstring with an Australian Spasticity Assessment Scale (ASAS) of 2 or more
  • ability of legal respondent to give written informed consent

Exclusion Criteria:

  • 6 months or less since the last botulinum injection on hamstring
  • surgical operation on lower limb within the last 12 months
  • severe contracture on hamstring

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 500 pulses
In this group, patients received one single rESWT session consisting of 500 pulses on hamstring muscle with energy flux density at 0.1 mJ/mm2, repetition frequency was at 4 Hz, and a pressure of 1.5 bars.
Device: radial Extracorporeal Shockwave Therapy
rESWT was given on hamstring muscles, with the subject lying on prone position. No anesthesia was required.
Other Names:
  • rESWT
EXPERIMENTAL: 1,000 pulses
In this group, patients received one single rESWT session consisting of 1,000 pulses on hamstring muscle with energy flux density at 0.1 mJ/mm2, repetition frequency was at 4 Hz, and a pressure of 1.5 bars.
Device: radial Extracorporeal Shockwave Therapy
rESWT was given on hamstring muscles, with the subject lying on prone position. No anesthesia was required.
Other Names:
  • rESWT
EXPERIMENTAL: 1,500 pulses
In this group, patients received one single rESWT session consisting of 1,500 pulses on hamstring muscle with energy flux density at 0.1 mJ/mm2, repetition frequency was at 4 Hz, and a pressure of 1.5 bars.
Device: radial Extracorporeal Shockwave Therapy
rESWT was given on hamstring muscles, with the subject lying on prone position. No anesthesia was required.
Other Names:
  • rESWT
EXPERIMENTAL: 2,000 pulses
In this group, patients received one single rESWT session consisting of 2,000 pulses on hamstring muscle with energy flux density at 0.1 mJ/mm2, repetition frequency was at 4 Hz, and a pressure of 1.5 bars.
Device: radial Extracorporeal Shockwave Therapy
rESWT was given on hamstring muscles, with the subject lying on prone position. No anesthesia was required.
Other Names:
  • rESWT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline Spasticity of Hamstring
Time Frame: Pre-ESWT
Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)
Pre-ESWT
Spasticity of Hamstring immediately post-ESWT
Time Frame: Immediately post-ESWT
Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)
Immediately post-ESWT
Spasticity of Hamstring 2 weeks post-ESWT
Time Frame: 2 weeks post-ESWT
Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)
2 weeks post-ESWT
Spasticity of Hamstring 4 weeks post-ESWT
Time Frame: 4 weeks post-ESWT
Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)
4 weeks post-ESWT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rizky Kusuma Wardhani

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 17, 2020

Primary Completion (ACTUAL)

March 26, 2020

Study Completion (ACTUAL)

March 26, 2020

Study Registration Dates

First Submitted

August 24, 2020

First Submitted That Met QC Criteria

September 4, 2020

First Posted (ACTUAL)

September 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 11, 2020

Last Update Submitted That Met QC Criteria

September 4, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LB.02/2.2/443/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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