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Effect of Massage Therapy and Occlusal Splint Therapy on the Electromyographic Activity and Mandibular Range of Motion in Individuals With Temporomandibular Disorder

Primary Purpose

Temporomandibular Disorder

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Massage
Occlusal splint
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorder focused on measuring Physical Therapy Modalities, Facial Pain, Orthodontic Appliances

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Nove de Julho

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Massage group

The occlusal splint group

Control group

Arm Description

The 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 was submitted to treatment with an occlusal splint for four weeks.

The control group was not submitted to any form of intervention and was evaluated on two occasions, with a four-week interval between evaluations.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Electromyographic activity
Electromyographic activity in the masseter and anterior temporal muscles. The right and left masseter and anterior temporal muscles were analyzed with surface EMG.

Full Information

First Posted
June 6, 2013
Last Updated
August 18, 2014
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT01874041
Brief Title
Effect of Massage Therapy and Occlusal Splint Therapy on the Electromyographic Activity and Mandibular Range of Motion in Individuals With Temporomandibular Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder
Keywords
Physical Therapy Modalities, Facial Pain, Orthodontic Appliances

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Massage group
Arm Type
Experimental
Arm Description
The massage group was submitted to three weekly 30-minute sessions of massage of the muscles of mastication over four consecutive weeks.
Arm Title
The occlusal splint group
Arm Type
Experimental
Arm Description
The occlusal splint group was submitted to treatment with an occlusal splint for four weeks.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group was not submitted to any form of intervention and was evaluated on two occasions, with a four-week interval between evaluations.
Intervention Type
Other
Intervention Name(s)
Massage
Intervention Type
Other
Intervention Name(s)
Occlusal splint
Primary Outcome Measure Information:
Title
Mandibular range of motion
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Electromyographic activity
Description
Electromyographic activity in the masseter and anterior temporal muscles. The right and left masseter and anterior temporal muscles were analyzed with surface EMG.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cid Gomes, MSc
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nove de Julho
City
São Paulo
ZIP/Postal Code
01504-001
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
25512839
Citation
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.
Results Reference
derived
Links:
URL
http://www.uninove.br
Description
Related Info

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Effect of Massage Therapy and Occlusal Splint Therapy on the Electromyographic Activity and Mandibular Range of Motion in Individuals With Temporomandibular Disorder

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