NCT01874041

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
Last Updated

August 19, 2014

Status Verified

August 1, 2014

Enrollment Period

1 year

First QC Date

June 6, 2013

Last Update Submit

August 18, 2014

Conditions

Keywords

Physical Therapy ModalitiesFacial PainOrthodontic Appliances

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

EXPERIMENTAL

The massage group was submitted to three weekly 30-minute sessions of massage of the muscles of mastication over four consecutive weeks.

Other: Massage

The occlusal splint group

EXPERIMENTAL

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

Other: Occlusal splint

Control group

NO INTERVENTION

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

Interventions

MassageOTHER
Massage group
The occlusal splint group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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.

Related Links

MeSH Terms

Conditions

Temporomandibular Joint DisordersFacial Pain

Interventions

MassageOcclusal Splints

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationOrthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Officials

  • Cid Gomes, MSc

    University of Nove de Julho

    PRINCIPAL INVESTIGATOR

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

Locations