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Immediate Effects of Posterior Mobilization Versus Caudal Mobilization in Patients With Temporomandibular Disorders (TMD)

Primary Purpose

Temporomandibular Disorders

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
POSTERIOR MOBILIZATION
CAUDAL MOBILIZATION
Sponsored by
Universidade Federal do Ceara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorders

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Individuals have not received the last 3 months treatment for TMD, who are not taking anti-inflammatory and / or analgesic for at least two weeks, you are not in the period of postoperative head and / or neck and to accept the participation in the study and signed the Instrument of Consent

Exclusion Criteria:

  • Subjects with no teeth, history of metabolic diseases (such as hyper / hypothyroidism), neurological disorders, history of cancer in the last five years, active inflammatory arthritis, fractures, dislocations of the jaw or neck.

Sites / Locations

  • Federal University of Ceara

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Posterior Mobilization

Caudal Mobilization

Arm Description

Patient supine on the gurney, previously trained physiotherapist with disposable gloves, one hand place your thumb on the lower lateral incisors and canines. Applies a force previous distraction grade III and performs oscillating for 1 minute.

Patient supine on the gurney, previously trained physiotherapist with disposable gloves, one hand place your thumb on the lower molars of patients. Apply simultaneous flow and force the previous direction, and performs the degree of oscillation III for 1 minute.

Outcomes

Primary Outcome Measures

Mandibular range of motion
The caliper is a measuring instrument that inform the millimetric values of mandibular depression, as measured the distance between the edges of the incisors of the maxilla and mandible. Three measurements of the active mouth opening will be held, where the individual experiencing pain, the measurement will be the beginning of it, if he does not feel pain, be gauged from the maximum amplitude of movement. Soon after the arithmetic mean of the measurements will be made.

Secondary Outcome Measures

Pain Intensity
Numeric Ratig Scale for Pain - 0 (no pain) and 10 (worst pain)

Full Information

First Posted
September 26, 2014
Last Updated
September 5, 2016
Sponsor
Universidade Federal do Ceara
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1. Study Identification

Unique Protocol Identification Number
NCT02263053
Brief Title
Immediate Effects of Posterior Mobilization Versus Caudal Mobilization in Patients With Temporomandibular Disorders
Acronym
TMD
Official Title
Immediate Effects of Posterior Mobilization Versus Caudal Mobilization in Patients With Temporomandibular Disorders: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Ceara

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The Temporomandibular Joint (TMJ) is one of the most complex joints in the individual. It is composed of the mandibular condyle is positioned within the glenoid fossa of the temporal bone, and the articular disk that separates these two bones. The normal biomechanics of the TMJ is the concave / convex relationship between the condyles and the articular disc. The movements of the TMJ joint are: mandibular depression and elevation (opening and closing of the mouth), mandibular protrusion and retraction, and lateral deviations. The DTM is a musculoskeletal disorder of the masticatory system that affects over 25% of the population. Physical therapy can be adopted this treatment in order to relieve musculoskeletal pain, reduce inflammation and restore normal motor functions. The physical therapy interventions taken include electrotherapy, exercise therapy, acupuncture and manual therapy. Overall objective is to assess the immediate effects of previous mobilization versus flow amplitude of mandibular depression in patients with temporomandibular dysfunction. The type of study will be a randomized study of two parallel groups balanced distribution (1: 1) and double-blind. The research will be conducted in the Laboratory of Human Movement Analysis of Physiotherapy, Faculty of Medicine, Federal University of Ceará. The study population will consist of residents in the city of Fortaleza-CE individuals who voluntarily seek to participate in the study due to symptoms of TMD. Data, anthropometry, application of Research Diagnostic Criteria for Temporomandibular Disorders will be collected. The physiotherapist responsible for the assessment before and after the interventions will be blind with respect to the distribution of the treatment groups. The patient will also be blind, because you will not know whether or caudal anterior mobilization was performed. Randomization codes are generated by computer using Random Allocation Software (version 1.0.0) at a ratio of 1: 1 by a researcher not involved in the data collection. These codes will be placed in sealed, opaque envelopes being numbered consecutively, which will ensure the covert allocation of study participants. Our data are considered confidential as joint property of the parties involved.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Posterior Mobilization
Arm Type
Active Comparator
Arm Description
Patient supine on the gurney, previously trained physiotherapist with disposable gloves, one hand place your thumb on the lower lateral incisors and canines. Applies a force previous distraction grade III and performs oscillating for 1 minute.
Arm Title
Caudal Mobilization
Arm Type
Active Comparator
Arm Description
Patient supine on the gurney, previously trained physiotherapist with disposable gloves, one hand place your thumb on the lower molars of patients. Apply simultaneous flow and force the previous direction, and performs the degree of oscillation III for 1 minute.
Intervention Type
Procedure
Intervention Name(s)
POSTERIOR MOBILIZATION
Intervention Description
Patient supine on the gurney, previously trained physiotherapist with disposable gloves, one hand place your thumb on the lower lateral incisors and canines. Applies a force previous distraction grade III and performs oscillating for 1 minute.
Intervention Type
Procedure
Intervention Name(s)
CAUDAL MOBILIZATION
Intervention Description
Patient supine on the gurney, previously trained physiotherapist with disposable gloves, one hand place your thumb on the lower molars of patients. Apply simultaneous flow and force the previous direction, and performs the degree of oscillation III for 1 minute.
Primary Outcome Measure Information:
Title
Mandibular range of motion
Description
The caliper is a measuring instrument that inform the millimetric values of mandibular depression, as measured the distance between the edges of the incisors of the maxilla and mandible. Three measurements of the active mouth opening will be held, where the individual experiencing pain, the measurement will be the beginning of it, if he does not feel pain, be gauged from the maximum amplitude of movement. Soon after the arithmetic mean of the measurements will be made.
Time Frame
Five minutes after mobilization
Secondary Outcome Measure Information:
Title
Pain Intensity
Description
Numeric Ratig Scale for Pain - 0 (no pain) and 10 (worst pain)
Time Frame
Five minutes after mobilization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals have not received the last 3 months treatment for TMD, who are not taking anti-inflammatory and / or analgesic for at least two weeks, you are not in the period of postoperative head and / or neck and to accept the participation in the study and signed the Instrument of Consent Exclusion Criteria: Subjects with no teeth, history of metabolic diseases (such as hyper / hypothyroidism), neurological disorders, history of cancer in the last five years, active inflammatory arthritis, fractures, dislocations of the jaw or neck.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel PL Almeida, MSc
Organizational Affiliation
Universidade Federal do Ceara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Ceara
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60430-160
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Immediate Effects of Posterior Mobilization Versus Caudal Mobilization in Patients With Temporomandibular Disorders

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