Effect of the Method Pilates in Women With Temporomandibular Disorders
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pain
Started Mar 2015
Typical duration for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2014
CompletedFirst Posted
Study publicly available on registry
November 17, 2014
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJune 23, 2017
June 1, 2017
1.9 years
November 6, 2014
June 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Severity of TMD
15 weeks
EMG activity of masticatory muscles
15 weeks
Posture
15 weeks
Study Arms (2)
Pilates
EXPERIMENTALIntervention group will undergo Pilates sessions in addition to conventional treatment with occlusal splint
Occlusal splint
NO INTERVENTIONControl group who receive conventional treatment with occlusal splint
Interventions
The intervention group will perform Pilates exercises for 15 weeks with frequency of twice weekly
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90690-200, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jefferson F Loss, Phd
Federal University of Rio Grande do Sul
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
- Doctor
Study Record Dates
First Submitted
November 6, 2014
First Posted
November 17, 2014
Study Start
March 1, 2015
Primary Completion
January 16, 2017
Study Completion
June 1, 2017
Last Updated
June 23, 2017
Record last verified: 2017-06