Effect of Session Frequency of rESWT on Gastrocnemius Muscle Spasticity in Children With Spastic Type Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Effect of Session Frequency of Radial Extracorporeal Shock Wave Therapy (rESWT) on Gastrocnemius Muscle Spasticity in Children With Spastic Type Cerebral Palsy: A Double-Blinded, Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04574622
• Other study ID #: KET885/UN2F1/ETIK/PPM0002/2019
• Status: Completed
• Phase: N/A
• Start date: January 17, 2020
• Est. completion date: June 17, 2020

Study information

• Verified date: September 2020
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 17, 2020
• Est. primary completion date: June 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• patients with spastic CP aged 5 to 18 years old

• at least one gastrocnemius 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 gastrocnemius

Related Conditions & MeSH terms

• Cerebral Palsy
• Child; Spastic
• Muscle Spasticity
• Paralysis
• Spasticity, Muscle

Intervention

Device:
• radial Extracorporeal Shockwave Therapy
rESWT was given on gastrocnemius muscles with the subject lying on prone position. No anesthesia was required.

Locations

Country	Name	City	State
Indonesia	Universitas Indonesia Fakultas Kedokteran	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Rizky Kusuma Wardhani

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline Spasticity of Gastrocnemius	Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)	pre-ESWT
Primary	Spasticity of Gastrocnemius after first ESWT session	Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)	After first ESWT session (Week 1)
Primary	Spasticity of Gastrocnemius after second ESWT session	Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)	After second ESWT session (Week 2)
Primary	Spasticity of Gastrocnemius after third ESWT session	Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)	After third ESWT session (Week 3)
Primary	Spasticity of Gastrocnemius after fourth ESWT session	Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)	After fourth ESWT session (Week 4)
Primary	Spasticity of Gastrocnemius after fifth ESWT session	Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)	After fifth ESWT session (Week 5)
Primary	Spasticity of Gastrocnemius four weeks after fifth (last) ESWT session	Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)	Four weeks after fifth (last) ESWT session (Week 9)
Primary	Spasticity of Gastrocnemius eight weeks after fifth (last) ESWT session	Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)	Eight weeks after fifth (last) ESWT session (Week 13)
Primary	Spasticity of Gastrocnemius twelve weeks after fifth (last) ESWT session	Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)	Twelve weeks after fifth (last) ESWT session (Week 17)