Temporomandibular DisordersTMDNCT02263053
Immediate Effects of Posterior Mobilization Versus Caudal Mobilization in Patients With Temporomandibular Disorders
A study testing POSTERIOR MOBILIZATION and CAUDAL MOBILIZATION in people with Temporomandibular Disorders, run by Universidade Federal do Ceara at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorders
- What is being tested?
- POSTERIOR MOBILIZATION and CAUDAL MOBILIZATION
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2014to Dec 2015
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effects of Posterior Mobilization Versus Caudal Mobilization in Patients With Temporomandibular Disorders: A Randomized Clinical Trial
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.
- Conditions
- Temporomandibular Disorders
- Being tested
- POSTERIOR MOBILIZATION, CAUDAL MOBILIZATION
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POSTERIOR MOBILIZATIONProcedure or surgery
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.
CAUDAL MOBILIZATIONProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Posterior Mobilization | Active comparator | 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. Receives: Procedure: CAUDAL MOBILIZATION |
| Caudal Mobilization | Active comparator | 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. Receives: Procedure: POSTERIOR MOBILIZATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Five minutes after mobilization
Secondary outcomes (1)
Pain Intensity
Numeric Ratig Scale for Pain - 0 (no pain) and 10 (worst pain)
Measured: Five minutes after mobilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisordersStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Ceara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Peixoto Leão Almeida, Universidade Federal do Ceara
- Investigators
- Gabriel PL Almeida, MSc, Principal investigator, Universidade Federal do Ceara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263053
- Sponsor's protocol ID
- UFCeara
- Acronym
- TMD
- Status last verified
- Sep 2016
- First submitted
- 26 Sep 2014
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Posterior Mobilization Versus Caudal Mobilization in Patients With Temporomandibular Disorders: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02263053
- Acronym / sponsor ID
- TMD / UFCeara
- Conditions
- Temporomandibular Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Universidade Federal do CearaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 Oct 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior Mobilization | Active comparator | Procedure: CAUDAL MOBILIZATIONPatient 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. |
| Caudal Mobilization | Active comparator | Procedure: POSTERIOR MOBILIZATIONPatient 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| POSTERIOR MOBILIZATIONPatient 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. | Procedure or surgery | Caudal Mobilization |
| CAUDAL MOBILIZATIONPatient 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. | Procedure or surgery | Posterior Mobilization |
Primary outcome
Mandibular range of motion
Time frame: Five minutes after mobilization
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.
1 secondary outcome
Pain Intensity
Time frame: Five minutes after mobilization
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 7 Sep 2016.
Related trials for Temporomandibular Disorders
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
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.
Gabriel PL Almeida, MSc principal investigator
Universidade Federal do Ceara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POSTERIOR MOBILIZATION and CAUDAL MOBILIZATION in people with Temporomandibular Disorders, run by Universidade Federal do Ceara 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 1 inclusion and 1 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 7 Sep 2016. 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?
Mandibular range of motion (time frame: Five minutes after mobilization). 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 7 Sep 2016.