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Effect of the Method Pilates in Women With Temporomandibular Disorders

Primary Purpose

Pain, Temporomandibular Joint Disorders

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Pilates

About this trial

This is an interventional treatment trial for Pain focused on measuring Temporomandibular Joint Disorders, posture, pain, clinical trial, Pilates

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Universidade Federal do Rio Grande do Sul

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pilates

Occlusal splint

Arm Description

Intervention group will undergo Pilates sessions in addition to conventional treatment with occlusal splint

Control group who receive conventional treatment with occlusal splint

Outcomes

Primary Outcome Measures

Pain Intensity Measure

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".

Secondary Outcome Measures

Severity of TMD

Severity of TMD will be assessed using the Mandibular Function Impairment Questionnaire (MFIQ).

EMG activity of masticatory muscles

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

Posture

Women posture will be assessed with photogrametry

Full Information

NCT ID

NCT02292355

First Posted

November 6, 2014

Last Updated

June 21, 2017

Sponsor

Federal University of Rio Grande do Sul

1. Study Identification

Unique Protocol Identification Number

NCT02292355

Brief Title

Effect of the Method Pilates in Women With Temporomandibular Disorders

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

March 2015 (undefined)

Primary Completion Date

January 16, 2017 (Actual)

Study Completion Date

June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of Rio Grande do Sul

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Temporomandibular Joint Disorders

Keywords

Temporomandibular Joint Disorders, posture, pain, clinical trial, Pilates

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pilates

Arm Type

Experimental

Arm Description

Intervention group will undergo Pilates sessions in addition to conventional treatment with occlusal splint

Arm Title

Occlusal splint

Arm Type

No Intervention

Arm Description

Control group who receive conventional treatment with occlusal splint

Intervention Type

Other

Intervention Name(s)

Pilates

Other Intervention Name(s)

Pilates exercises, Pilates method

Intervention Description

The intervention group will perform Pilates exercises for 15 weeks with frequency of twice weekly

Primary Outcome Measure Information:

Title

Pain Intensity Measure

Description

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".

Time Frame

15 weeks

Secondary Outcome Measure Information:

Title

Severity of TMD

Description

Severity of TMD will be assessed using the Mandibular Function Impairment Questionnaire (MFIQ).

Time Frame

15 weeks

Title

EMG activity of masticatory muscles

Description

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

Time Frame

15 weeks

Title

Posture

Description

Women posture will be assessed with photogrametry

Time Frame

15 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jefferson F Loss, Phd

Organizational Affiliation

Federal University of Rio Grande do Sul

Official's Role

Study Director

Facility Information:

Facility Name

Universidade Federal do Rio Grande do Sul

City

Porto Alegre

State/Province

ZIP/Postal Code

90690-200

Country

Brazil

12. IPD Sharing Statement

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Effect of the Method Pilates in Women With Temporomandibular Disorders

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