Effect of the Method Pilates in Women With Temporomandibular Disorders

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02292355
• Other study ID #: URioGrande
• Status: Completed
• Phase: N/A
• First received: November 6, 2014
• Last updated: June 21, 2017
• Start date: March 2015
• Est. completion date: June 2017

Study information

• Verified date: June 2017
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2017
• Est. primary completion date: January 16, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Joint Diseases
• Pain
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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

Locations

Country	Name	City	State
Brazil	Universidade Federal do Rio Grande do Sul	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	15 weeks
Secondary	Severity of TMD	Severity of TMD will be assessed using the Mandibular Function Impairment Questionnaire (MFIQ).	15 weeks
Secondary	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	15 weeks
Secondary	Posture	Women posture will be assessed with photogrametry	15 weeks