Effect of the Method Pilates in Women With Temporomandibular Disorders

June 21, 2017 updated by: Jefferson Fagundes Loss, Federal University of Rio Grande do Sul

Effect of the Method Pilates in Women With Temporomandibular Disorders - Clinical Trial

Introduction: the influence of temporomandibular disorders (TMD) related to postural changes are yet no consensus, but it is believed that the imbalances of a system can influence another. Several techniques have been used to treat TMD and its associated problems, however there is a paucity of studies evaluating the effects of global treatments, such as Pilates, in individuals with TMD literature. Objective: To evaluate changes in the level of pain, the severity of TMD, the EMG activity of masticatory muscles and posture of young women undergoing training in Pilates, as well as correlating postural changes, pain level, severity of TMD and EMG activity of masticatory muscles. A randomized clinical trial with blinded assessors will be held. 40 patients divided randomly into two groups will be assessed, the control group (CG) who receive conventional treatment with occlusal splint and intervention group (IG), which in addition to conventional treatment will undergo Pilates sessions. Both groups will be formed for women aged 18 to 35 years with TMD and pain. The IG will receive treatment with the Pilates Method for 15 weeks with frequency of twice weekly and use occlusal splint as directed by the dentist. The CG will make use of occlusal splint alone. At the beginning and end of the 15 weeks the individuals are evaluated to verify the presence of TMD, TMD severity, pain, EMG evaluation of masticatory muscles and body posture. Data will be analyzed statistically.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

t-test or Mann-Whitney test will be used to compare data before and after 15 weeks of treatment.

Multiple Two-Way ANOVAs will be used to compare treatment and evaluation period, for each depended variable: effects of pain, severity of TMD, EMG activity of masticatory muscles and posture.

Study Type

Interventional

Enrollment (Actual)

40

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

    • RS
      • Porto Alegre, RS, Brazil, 90690-200
        • Universidade Federal do Rio Grande do Sul

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 35 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women between 18 and 35 years old;
  • Possess temporomandibular disorder diagnosed by the Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD) and classified into categories of severity of functional limitation through the Mandibular Function Impairment Questionnaire MFIQ
  • Owning a complaint of pain in the TMJ region, classified as greater than 2.5 (moderate to high) by the Visual Analog Scale.

Exclusion Criteria:

  • Have greater than 35 kg / m2 body mass index (BMI);
  • Diagnosis of other disorders of the stomatognathic system;
  • Have a history of any surgical procedure on the face, teeth and spine in the last six months;
  • Possess severe pathologies of the spine (fractures, inflammatory diseases or tumors);
  • Provide framework for intellectual disability or inability to give consistent information;
  • Being in treatment for TMD, be it physical therapy, medical or dental care throughout the study period.
  • Being practicing Pilates in the last six months;
  • Being pregnant;
  • Make use of dental prosthesis or appliance;
  • Have a history of trauma to the face and temporomandibular joint in the last six months;
  • Having presented temporomandibular joint dislocation in the last six months;
  • Possess dental flaws between canines and molars.
  • Provide cross bite, overbite or open bite;
  • Presenting undershot or overshot jaw;
  • Present vestibular disorders that may interfere with the balance
  • Make use of continuous medication for pain or inflammation.

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pilates
Intervention group will undergo Pilates sessions in addition to conventional treatment with occlusal splint
The intervention group will perform Pilates exercises for 15 weeks with frequency of twice weekly
Other Names:
  • Pilates method
  • Pilates exercises
NO_INTERVENTION: Occlusal splint
Control group who receive conventional treatment with occlusal splint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity Measure
Time Frame: 15 weeks
Pain intensity will be assessed using visual analog scale (VAS), which consists of a 10-cm horizontal line in which "0" means "No pain" and "10" means "The worst pain I can imagine".
15 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of TMD
Time Frame: 15 weeks
Severity of TMD will be assessed using the Mandibular Function Impairment Questionnaire (MFIQ).
15 weeks
EMG activity of masticatory muscles
Time Frame: 15 weeks
EMG activity of masticatory muscles will be assessed using a surface eletromyography. Right and left masseter and temporalis muscles EMG activity will be record during 10 s of a masticatory activity
15 weeks
Posture
Time Frame: 15 weeks
Women posture will be assessed with photogrametry
15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

March 1, 2015

Primary Completion (ACTUAL)

January 16, 2017

Study Completion (ACTUAL)

June 1, 2017

Study Registration Dates

First Submitted

November 6, 2014

First Submitted That Met QC Criteria

November 12, 2014

First Posted (ESTIMATE)

November 17, 2014

Study Record Updates

Last Update Posted (ACTUAL)

June 23, 2017

Last Update Submitted That Met QC Criteria

June 21, 2017

Last Verified

June 1, 2017

More Information

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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