Analysis of the Effects of the Osteopathic Manipulative Treatment in Carriers of Temporomandibular Disorders

November 22, 2016 updated by: Thiago Boeira Susin, PT, DO, Instituto Brasileiro de Osteopatia

Analysis of the Effects of the Osteopathic Manipulative Treatment in Carriers of Temporomandibular Disorders: Randomized Clinical Trial

The purpose of this study is to determine whether osteopathic manipulative treatment associated to Dentistry care and speech therapy improves pain and function in individuals with temporomandibular disorders.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A standardized TMD examination was executed in all patients by a dentist following the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/ TMD) questionnaire, Axis I and II, portuguese version. The RDC/ TMD is compound by a 31 items questionnaire and a ten items clinical exam. All these items are related to patients symptoms and signs; to mandibular functional impairment; and social-demographics, social-economics, psychological e psychosocial data. The first part as Axis I tend to clinical assess and classify the TMD and the second, as Axis II propose a chronic pain score that could quantify the psychosocial impairment and present a subjects profile.

Others assessment instruments utilized on the research were the VAS consists in a 10 cm horizontal line with "no pain" on the left side and "worst pain" on right side, then the subjects were instructed to vertical risk the level of pain. The digital caliper with a 0,03 mm precision was used to measure the maximal mouth opening (MMO) as the maximal inter-incisal vertical distance of the incisors. The subjects were seated at 90° with neutral head position and solicited to open their mouths the maximum they can unassisted and without pain, maximum unassisted opening and maximum assisted opening. Also, a portable digital pressure algometer for measuring sensitivity to pressure before it became painful. The masseters and temporalis muscles trigger point location were used as reference to guarantee the reproducibility of the proceeding as well as to assess the always the same site. The statistical analysis was performed using the means comparisons for the parametric tests through Student T test and for the non-parametrical data, Wilcoxon. Also, it was made the descriptive statistical with frequencies analysis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil
        • Brazilian Institute of Osteopathy

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • subjects of both genders with TMD diagnosed and minimum pain intensity of 40 mm on a visual analogue scale (VAS) who need dental treatment.

Exclusion Criteria:

  • continuous use of analgesic medication, mouth opening above 40 mm, presence of any other orofacial pain not related to TMD and being under orthodontic or TMD treatment.

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Conventional Group
Individuals with temporomandibular disorder were used rigid occlusal splints and medication (Ibuprofen and Cyclobenzaprine Hydrochloride) under the dentist professor supervision. Likewise, speech therapists performed assessments, measurements, massages, stretches and therapeutic exercises for head, neck and mouth regions during four weeks.
Other: Conventional Group
Rigid occlusal splints and medication (Ibuprofen and Cyclobenzaprine Hydrochloride) were made and prescribed under the dentist professor supervision. Likewise, speech therapists performed assessments, measurements, massages, stretches and therapeutic exercises for head, neck and mouth regions.
Drug: Ibuprofen
The medication was prescribed by the dentist as nonsteroidal anti-inflammatory drug if necessary.
Other Names:
  • anti-inflammatory drug
Drug: Cyclobenzaprine Hydrochloride
The medication was prescribed by the dentist as muscle relaxer if necessary.
Other Names:
  • muscle relaxer
Experimental: Osteopathic Group
Individuals with temporomandibular disorder received the same assistance of Conventional Group, cited above, plus the osteopathic care during 20 to 30 minutes once a week until the end of dental and speech therapy treatments (4 weeks).
Drug: Ibuprofen
The medication was prescribed by the dentist as nonsteroidal anti-inflammatory drug if necessary.
Other Names:
  • anti-inflammatory drug
Drug: Cyclobenzaprine Hydrochloride
The medication was prescribed by the dentist as muscle relaxer if necessary.
Other Names:
  • muscle relaxer
Other: Osteopathic Group
Same assistance of Conventional Group, cited above, plus the osteopathic care during 20 to 30 minutes once a week during four weeks. The osteopathic treatment consisted in an individualized assessment of mobility restrictions of myofascial tissues and joints and the application of smooth techniques such myofascial release, membranous strain and counterstrain, muscle energy, cranial and high velocity and low amplitude.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: 4 weeks
Pain assessed by visual analogue scale.
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
(RDC/ TMD) Research Diagnostic Criteria for Temporomandibular Disorders
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto Brasileiro de Osteopatia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thiago B Susin, IBO

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 28, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • InstitutoBOsteopatia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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