- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02292355
Effect of the Method Pilates in Women With Temporomandibular Disorders
June 21, 2017 updated by: Jefferson Fagundes Loss, Federal University of Rio Grande do Sul
Effect of the Method Pilates in Women With Temporomandibular Disorders - Clinical Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RS
-
Porto Alegre, RS, Brazil, 90690-200
- Universidade Federal do Rio Grande do Sul
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Pilates
Intervention group will undergo Pilates sessions in addition to conventional treatment with occlusal splint
|
The intervention group will perform Pilates exercises for 15 weeks with frequency of twice weekly
Other Names:
|
|
NO_INTERVENTION: Occlusal splint
Control group who receive conventional treatment with occlusal splint
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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".
|
15 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Severity of TMD
Time Frame: 15 weeks
|
Severity of TMD will be assessed using the Mandibular Function Impairment Questionnaire (MFIQ).
|
15 weeks
|
|
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
|
15 weeks
|
|
Posture
Time Frame: 15 weeks
|
Women posture will be assessed with photogrametry
|
15 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (ACTUAL)
January 16, 2017
Study Completion (ACTUAL)
June 1, 2017
Study Registration Dates
First Submitted
November 6, 2014
First Submitted That Met QC Criteria
November 12, 2014
First Posted (ESTIMATE)
November 17, 2014
Study Record Updates
Last Update Posted (ACTUAL)
June 23, 2017
Last Update Submitted That Met QC Criteria
June 21, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- URioGrande
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
Boston Scientific CorporationRecruitingLow Back Pain | Chronic Pain | Chronic Low-back Pain | Leg Pain | Intractable Pain | Chronic Leg PainUnited States
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Qi's ClinicNot yet recruitingNon-Cancer Pain,Musculoskeletal Pain,Chronic Pain,Acute Pain
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
noiVita SrlsUniversity of Eastern PiedmontCompletedCervical Pain | Pain Management | Lumbar Pain | Muscular | Chronic Pain (Back / Neck)Italy
-
Chinese University of Hong KongNot yet recruitingPain, Acute | Chronic Post Operative Pain | Pain, ChronicHong Kong
-
University of SaskatchewanRoyal University Hospital FoundationCompletedPain | Pain, Acute | Pain, Chronic | Pain, IntractableCanada
-
Kyowa Kirin Co., Ltd.Completed
Clinical Trials on Pilates
-
Istanbul Medipol University HospitalCompleted
-
Universidade Cidade de Sao PauloCompleted
-
University of Colorado, Colorado SpringsUniversity of Illinois at Urbana-ChampaignCompleted
-
Istanbul Medipol University HospitalCompleted
-
Universidade Federal de Santa MariaCompleted
-
Pontificia Universidade Católica do Rio Grande...Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Fundação de Amparo... and other collaboratorsCompletedAging | Mobility Limitation | Postural BalanceBrazil
-
Uskudar UniversityCompletedOccupational DiseasesTurkey (Türkiye)
-
Michele de Aguiar ZacariaRecruiting
-
Istanbul Medipol University HospitalCompleted
-
Uskudar UniversityCompletedLow Back Pain | Kinesiophobia | Disc HerniationTurkey (Türkiye)