Effect of Massage Therapy and Occlusal Splint Therapy on the Electromyographic Activity and Mandibular Range of Motion in Individuals With Temporomandibular Disorder
1 other identifier
interventional
42
1 country
1
Brief Summary
The objectives of this study were to investigate the effects of massage therapy and occlusal splint therapy in the electromyographic activity and mandibular range of motion (ROM) in individuals with temporomandibular disorder (TMD) and compare the results with those obtained in a group of individuals without this disorder. Twenty-eight volunteers with TMD were randomly distributed into two groups, massage therapy and occlusal splint. Both treatments lasted 4 weeks. Fourteen individuals without TMD were consecutively allocated to the control group. The Fonseca's anamnestic index was used to characterize TMD and allocate the volunteers to either the intervention groups or control group. The electromyographic activity and Mandibular ROM was evaluated before and after treatment using a digital caliper. Two-way analysis of variance with the Bonferroni test was used for inter and intragroup comparisons (level of significance was set to 5%). Cohen's d was used to calculate the effect size.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 6, 2013
CompletedFirst Posted
Study publicly available on registry
June 10, 2013
CompletedAugust 19, 2014
August 1, 2014
1 year
June 6, 2013
August 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mandibular range of motion
Mandibular range of motion(maximum active mouth opening, and right and left lateral excursion) was evaluated by a blinded examiner on two occasions (before and after treatment) using a digital caliper.
1 year
Secondary Outcomes (1)
Electromyographic activity
1 year
Study Arms (3)
Massage group
EXPERIMENTALThe massage group was submitted to three weekly 30-minute sessions of massage of the muscles of mastication over four consecutive weeks.
The occlusal splint group
EXPERIMENTALThe occlusal splint group was submitted to treatment with an occlusal splint for four weeks.
Control group
NO INTERVENTIONThe control group was not submitted to any form of intervention and was evaluated on two occasions, with a four-week interval between evaluations.
Interventions
Eligibility Criteria
You may qualify if:
- male and female volunteers
- aged 18 to 40 years
You may not qualify if:
- occurrence of missing teeth
- current use of orthodontic appliance
- history of systemic or joint disease
- current use of analgesic, anti-inflammatory agent or muscle relaxant and currently undergoing physical therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Nove de Julho
São Paulo, São Paulo, 01504-001, Brazil
Related Publications (1)
Gomes CA, El Hage Y, Amaral AP, Politti F, Biasotto-Gonzalez DA. Effects of massage therapy and occlusal splint therapy on electromyographic activity and the intensity of signs and symptoms in individuals with temporomandibular disorder and sleep bruxism: a randomized clinical trial. Chiropr Man Therap. 2014 Dec 15;22(1):43. doi: 10.1186/s12998-014-0043-6. eCollection 2014.
PMID: 25512839DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cid Gomes, MSc
University of Nove de Julho
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MSc
Study Record Dates
First Submitted
June 6, 2013
First Posted
June 10, 2013
Study Start
January 1, 2010
Primary Completion
January 1, 2011
Study Completion
December 1, 2012
Last Updated
August 19, 2014
Record last verified: 2014-08