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Trial record 1 of 20 for:    temporomandibular joint dysfunction AND (woman OR women OR female)
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Effect of the Method Pilates in Women With Temporomandibular Disorders

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02292355
First Posted: November 17, 2014
Last Update Posted: June 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jefferson Fagundes Loss, Federal University of Rio Grande do Sul
  Purpose
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.

Condition Intervention
Pain Temporomandibular Joint Disorders Other: Pilates

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of the Method Pilates in Women With Temporomandibular Disorders - Clinical Trial

Resource links provided by NLM:


Further study details as provided by Jefferson Fagundes Loss, Federal University of Rio Grande do Sul:

Primary Outcome Measures:
  • 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".


Secondary Outcome Measures:
  • Severity of TMD [ Time Frame: 15 weeks ]
    Severity of TMD will be assessed using the Mandibular Function Impairment Questionnaire (MFIQ).

  • 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

  • Posture [ Time Frame: 15 weeks ]
    Women posture will be assessed with photogrametry


Enrollment: 40
Study Start Date: March 2015
Study Completion Date: June 2017
Primary Completion Date: January 16, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pilates
Intervention group will undergo Pilates sessions in addition to conventional treatment with occlusal splint
Other: Pilates
The intervention group will perform Pilates exercises for 15 weeks with frequency of twice weekly
Other Names:
  • Pilates exercises
  • Pilates method
No Intervention: Occlusal splint
Control group who receive conventional treatment with occlusal splint

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02292355


Locations
Brazil
Universidade Federal do Rio Grande do Sul
Porto Alegre, RS, Brazil, 90690-200
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Investigators
Study Director: Jefferson F Loss, Phd Federal University of Rio Grande do Sul
  More Information

Responsible Party: Jefferson Fagundes Loss, Doctor, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT02292355     History of Changes
Other Study ID Numbers: URioGrande
First Submitted: November 6, 2014
First Posted: November 17, 2014
Last Update Posted: June 23, 2017
Last Verified: June 2017

Keywords provided by Jefferson Fagundes Loss, Federal University of Rio Grande do Sul:
Temporomandibular Joint Disorders
posture
pain
clinical trial
Pilates

Additional relevant MeSH terms:
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Joint Diseases
Disease
Pathologic Processes
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes