- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01874041
Effect of Massage Therapy and Occlusal Splint Therapy on the Electromyographic Activity and Mandibular Range of Motion in Individuals With Temporomandibular Disorder
August 18, 2014 updated by: Cid André Fidelis de Paula Gomes, University of Nove de Julho
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
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
-
-
-
São Paulo, Brazil, 01504-001
- University of Nove de Julho
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-
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
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- male and female volunteers
- aged 18 to 40 years
Exclusion Criteria:
- 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.
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 Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Massage group
The massage group was submitted to three weekly 30-minute sessions of massage of the muscles of mastication over four consecutive weeks.
|
|
Experimental: The occlusal splint group
The occlusal splint group was submitted to treatment with an occlusal splint for four weeks.
|
|
No Intervention: Control group
The control group was not submitted to any form of intervention and was evaluated on two occasions, with a four-week interval between evaluations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mandibular range of motion
Time Frame: 1 year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Electromyographic activity
Time Frame: 1 year
|
Electromyographic activity in the masseter and anterior temporal muscles.
The right and left masseter and anterior temporal muscles were analyzed with surface EMG.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cid Gomes, MSc, University of Nove de Julho
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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
January 1, 2010
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
June 6, 2013
First Submitted That Met QC Criteria
June 6, 2013
First Posted (Estimate)
June 10, 2013
Study Record Updates
Last Update Posted (Estimate)
August 19, 2014
Last Update Submitted That Met QC Criteria
August 18, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Muscular Diseases
- Stomatognathic Diseases
- Jaw Diseases
- Craniomandibular Disorders
- Mandibular Diseases
- Myofascial Pain Syndromes
- Temporomandibular Joint Disorders
- Temporomandibular Joint Dysfunction Syndrome
- Anti-Infective Agents
- Dermatologic Agents
- Antifungal Agents
- Keratolytic Agents
- Salicylic Acid
Other Study ID Numbers
- U1111-1144-0809
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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