PainNCT02292355
Effect of the Method Pilates in Women With Temporomandibular Disorders
A study testing Pilates in people with Pain and Temporomandibular Joint Disorders, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Pain, Temporomandibular Joint Disorders
- What is being tested?
- Pilates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90690-200
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Temporomandibular Joint Disorders
- Being tested
- Pilates
- Keywords
- Temporomandibular Joint Disorders, posture, pain, clinical trial, Pilates
- Medical subject headings
- Pain, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PilatesOther
Also called Pilates exercises, Pilates method
The intervention group will perform Pilates exercises for 15 weeks with frequency of twice weekly
| Study group | Role | What they receive |
|---|---|---|
| Pilates | Experimental | Intervention group will undergo Pilates sessions in addition to conventional treatment with occlusal splint Receives: Other: Pilates |
| Occlusal splint | No intervention | Control group who receive conventional treatment with occlusal splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 15 weeks
Secondary outcomes (3)
Severity of TMD
Severity of TMD will be assessed using the Mandibular Function Impairment Questionnaire (MFIQ).
Measured: 15 weeks
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
Measured: 15 weeks
Posture
Women posture will be assessed with photogrametry
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startMar 2015
- Primary completion16 Jan 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jefferson Fagundes Loss, Federal University of Rio Grande do Sul
- Investigators
- Jefferson F Loss, Phd, Study director, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292355
- Sponsor's protocol ID
- URioGrande
- Status last verified
- Jun 2017
- First submitted
- 6 Nov 2014
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Method Pilates in Women With Temporomandibular Disorders - Clinical Trial
- ClinicalTrials.gov ID
- NCT02292355
- Acronym / sponsor ID
- URioGrande
- Conditions
- Pain, Temporomandibular Joint Disorders
- Keywords
- Temporomandibular Joint Disorders, posture, pain, clinical trial, Pilates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- 16 Jan 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 17 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates | Experimental | Other: PilatesIntervention group will undergo Pilates sessions in addition to conventional treatment with occlusal splint |
| Occlusal splint | No intervention | –Control group who receive conventional treatment with occlusal splint |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PilatesAlso: Pilates exercises, Pilates methodThe intervention group will perform Pilates exercises for 15 weeks with frequency of twice weekly | Other | Pilates |
Primary outcome
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".
3 secondary outcomes
Severity of TMD
Time frame: 15 weeks
EMG activity of masticatory muscles
Time frame: 15 weeks
Posture
Time frame: 15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jefferson F Loss, Phd study director
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates in people with Pain and Temporomandibular Joint Disorders, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Measure (time frame: 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2017.