NCT02292355

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 23, 2017

Status Verified

June 1, 2017

Enrollment Period

1.9 years

First QC Date

November 6, 2014

Last Update Submit

June 21, 2017

Conditions

Keywords

Temporomandibular Joint Disordersposturepainclinical trialPilates

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

EXPERIMENTAL

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

Other: Pilates

Occlusal splint

NO INTERVENTION

Control group who receive conventional treatment with occlusal splint

Interventions

PilatesOTHER

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

Also known as: Pilates exercises, Pilates method
Pilates

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

PainTemporomandibular Joint Disorders

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Jefferson F Loss, Phd

    Federal University of Rio Grande do Sul

    STUDY DIRECTOR

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

Locations