Effects of laser therapy on the masseter of children with spastic cerebral palsy

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-5n3mtj
• Date of registration: 14/09/2015
• Prospective Registration: No
• Primary sponsor: Universidade Cruzeiro do Sul
• Public title: Effects of laser therapy on the masseter of children with spastic cerebral palsy
• Scientific title: Effects of photobiomodulation on the masseter of children with spastic cerebral palsy
• Date of first enrolment: 01/10/2014
• Recruitment status: Recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-5n3mtj
• Study type: Intervention
• Study design: Clinical trial nonrandomized treatment, parallel, with three arms.
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Maria Teresa Botti R Rodrigues Santos
• Affiliation: Universidade Cruzeiro do Sul

• Name: Maria Teresa Botti R Rodrigues Santos
• Affiliation: Universidade Cruzeiro do Sul

Key inclusion & exclusion criteria

Inclusion criteria: Cerebral palsy diagnosis of spastic type;
with or without complaints of pain mouth opening;
difficulty in performing oral hygiene;
utensils locking used for food or for oral hygiene;
trauma story in oral tissues
Exclusion criteria: Patients diagnosed with cerebral palsy spastic type associated with syndromes or other disabling condition.

Age minimum: 7Y
Age maximum: 18Y
Gender: -

Health Condition(s) or Problem(s) studied

Cerebral palsy

Intervention(s)

E02.594.540

Procedure/surgery

The experiemental group will be composed of 30 children diagnosed with cerebral palsy whose caregivers to report difficulty in cleaning by decreased mouth opening, locking utensils used for food and story plot in oral tissues.

Two ultrasound examinations of the muscles masseter left right will be realized. The first before the photobiostimulation and the second after 6 weeks.

It will be used the infrared Laser, Diode, low intensity, As-Ga-Al, (? = 808 ± 3 nm, 45J / cm², 30 mW) for 6 sessions, with an interval of seven days between sessions. The areas to be irradiated will be the masseter muscle bilaterally.

Caregivers answer which the value of the discomfort they observed for oral hygiene and food, registered before each application photobiostimulation.

Untreated group: It will consist of 30 children diagnosed with cerebral palsy without complaint difficult cleaning by decreased mouth opening, locking utensils used for food and weft of history in oral tissues; and 30 children without neurological damage.

This group will be held 2 ultrasound examinations of the muscles masseter left right, the first being the initial assessment and the second seven days after the initial.

The Ultrasound assessment of the thickness of the masseter muscle will be performed using the methodology proposed by Satiroglu et al.12 All tests will be performed by a single radiologist Diagnostic Center of the Association for Assistance to Disabled Children, Ibirapuera unit, using the portable ultrasound equipment ACUSON X300.
During the images acquisition, the transducer will be positioned perpendicular to the surface of the patient's skin, avoiding excessive pressing.
The measures will be obtained in the most voluminous portion of the masseter, near

Other

Primary Outcome(s)

The expected outcome is to change the thickness of the masseter muscle.

The method used to check the expected outcome will be the sonographic examination of the thickness of the masseter muscle

The parameter to be used to evaluate the occurrence of the outcome of the verification is a variation of at least 5% in pre and post-intervention measurements by means of ultrasound method of the masseter

Secondary Outcome(s)

The expected outcome is to reduce the pain described by the caregiver.

Visual analog scale (VAS) is the method used to verify the expected outcome.

The parameter to be used to evaluate the occurrence of the outcome will be based on the statement of a variation of at least 5% in pre and post intervention measurements, checked by visual analog scale (VAS) by caregiver report.

Source(s) of Monetary Support

Fundação de Amparo à Pesquisa do Estado de São Paulo

Secondary Sponsor(s)

Associação de Assistência à Criança Deficiente