Temporomandibular Joint DysfunctionTEMCMAPTTSNCT02822469
Thermograph Evaluation of Masticatory and Cervical Muscles After Physiotherapeutic Treatment in Tmd Subjects
A study testing Manual Therapy Treatment in people with Temporomandibular Joint Dysfunction, run by Daniela Ap. Biasotto-Gonzalez at 1 site in Brazil.
Trial summary
Background: Different therapeutic approaches have been proposed for the treatment of TMD. Myofascial and joint techniques, exercises, intraoral devices, thermal, electro and phototherapy applications, are among the most common. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Temporomandibular Joint Dysfunction
- What is being tested?
- Manual Therapy Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2016to Dec 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 45 years;
- presence of pain in the facial region in the last 6 months;
- diagnosis of myofascial pain (I) and/or disc displacement (IIa and IIb) determined by the DRC/TMD; Moderate DTM Record carrier or determined by Fonseca Anamnesic Index.
Who cannot join
- A history of trauma/cervical surgery and/or craniofacial;
- Neurological disorders;
- cervical disc disease;
- degenerative diseases of the spine;
- systemic diseases;
- diagnosis of fibromyalgia;
Show all 11Show fewer
- prior treatments for TMD for the last 3 months;
- orthodontic treatment/orthopedic in progress;
- continuous use of analgesics, anti-inflammatories, anxiolytics and/or antidepressants;
- BMI> 25 kg / m2;
- pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thermograph Evaluation of Masticatory Muscles Pre and Post Indirect Physiotherapeutic Treatment in TMD Subjects: A Randomized, Placebo-controlled Study
Background: Different therapeutic approaches have been proposed for the treatment of TMD. Myofascial and joint techniques, exercises, intraoral devices, thermal, electro and phototherapy applications, are among the most common. The combination of local treatments and adjacent structures such as the cervical region have also been studied in this area. It is believed that the anatomic proximity, neuronal interconnections and convergent afferents from the trigeminal and cervical areas can lead the understanding of the relationship of these structures. In order to assess the effects of these different forms of treatment studies have used different resources such as diagnostic imaging and biological signals, in order to complement the clinical diagnosis. Infrared thermography has been one of the resource assessment in the literature and it is interesting and stands out from other methods because it is functional, non-invasive and inexpensive.
Purpose: To evaluate the thermograms concerning the masseter and anterior temporal muscles, severity, pain, range of mandibular motion and neck disability in TMD patients, before and after physical therapy applied to the cervical and thoracic regions.
Read more
Methods: This is a randomized, placebo-controlled study, designed to evaluate the effects of indirect treatment on the thermography of the masticatory muscles, severity, pain, range of motion and neck disability in individuals with TMD. These will be randomized and allocated into two groups: GA (intervention) and GB (placebo) and assessed as: Diagnostic Criteria for Temporomandibular Research Disorders (RDC/TMD), Fonseca´s Anamnesic Index (FAI), Thermography, EVA, IDD-CF, Pachymetry and Neck Disability Index (NDI).
Statistical analysis: The temperature of the orofacial region, acquired through thermography is considered the primary endpoint and as a secondary endpoint will be the evaluation of the severity according to FAI, pain by VAS and IDD-CF, the range of mandibular motion by pachymetry and neck disability by NDI.
Statistical analysis: The normality of the data will be verified using the Kolmogorov-Smirnov test, which will be expressed as mean and standard deviation and/or median and interquartile range. Repeated measures analysis of variance of two factors, post hoc Bonferroni will be used for inter and intra-group comparisons. The significance level of p≤0.05 is set.
Read the detailed description
This is a randomized, placebo-controlled, study designed to evaluate the thermograms concerning the masseter and anterior temporal muscles, severity, pain, range of mandibular motion and neck disability in TMD patients, before and after physical therapy applied to the cervical and thoracic regions.
- Conditions
- Temporomandibular Joint Dysfunction
- Being tested
- Manual Therapy Treatment, Placebo Ultrasound
- Keywords
- TMD Infrared Thermography Physical Therapy Modalities
- 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.
Manual Therapy TreatmentOther
Treatment starts with 10 deep breathing movements for global relaxation. The anterior and posterior neck muscles, shoulder girdle and subdiaphragmatic will be addressed with myofascial techniques repeated 10 times in each stroke. The cervical spine will be pulled in the longitudinal direction. The draw will be held 1 time, lasting 1 minute. The thoracic region will receive mobilization technique in the anteroposterior direction,10 repeated movements involving all thoracic segment.
The treatment will be applied previously trained therapists, 4 weeks, 2 times a week, totaling eight sessions. The treatment time per session is about 25 minutes.
Placebo UltrasoundDevice
A detuned pulsed ultrasound will be applied to regions of the muscles around the shoulder girdle and anterior posterior cervical, for 25 minutes (2.5 minutes in each zone ). The device will be used with the internal cables disconnected for the placebo effect . However, you can handle it and adjust the doses and alarms as it is connected in order to simulate clinical practice and increase the credibility of the use of this device in the voluntary . The placebo treatment will be applied by previously trained therapists. Treatment will have 4 weeks, 2 times a week, totaling eight sessions.
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy Treatment Group | Experimental | Severe and Moderate TMD patients who filled the inclusion criteria who will receive the Manual Therapy Treatment Receives: Other: Manual Therapy Treatment |
| Placebo Ultrasound Treatment Group | Placebo comparator | Severe and Moderate TMD patients who filled the inclusion criteria who will receive the Placebo Treatment. Receives: Device: Placebo Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Skin Temperature
Measured by the Infrared thermographic digital camera
Measured: Baseline and 4 weeks
Secondary outcomes (5)
Changes in TMD severity
Measured by Fonseca´s Anamnesic Index
Measured: Baseline and 4 weeks
Changes in Neck disability
Measured by the Neck Disability Index
Measured: Baseline and 4 weeks
Changes in Pain incapacity
Measured by the IDD-CF
Measured: Baseline and 4 weeks
Changes in Movement Range of Motion (Opening)
Measured using a pachymeter (mean values of 3 opening measures)
Measured: Baseline and 4 weeks
Changes in Referred Pain
Measured by Visual Analogic Scale
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DysfunctionStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniela Ap. Biasotto-Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniela Ap. Biasotto-Gonzalez, University of Nove de Julho
- Investigators
- Daniela Ap Biasotto-Gonzalez, PHD, Study chair, Study Principal Investigator - Universidade Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822469
- Sponsor's protocol ID
- 2YEH1984
- Acronym
- TEMCMAPTTS
- Status last verified
- Feb 2022
- First submitted
- 23 Jun 2016
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermograph Evaluation of Masticatory Muscles Pre and Post Indirect Physiotherapeutic Treatment in TMD Subjects: A Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT02822469
- Acronym / sponsor ID
- TEMCMAPTTS / 2YEH1984
- Conditions
- Temporomandibular Joint Dysfunction
- Keywords
- TMD Infrared Thermography Physical Therapy Modalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Daniela Ap. Biasotto-GonzalezUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 4 Jul 2016 (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.
Background: Different therapeutic approaches have been proposed for the treatment of TMD. Myofascial and joint techniques, exercises, intraoral devices, thermal, electro and phototherapy applications, are among the most common. The combination of local treatments and adjacent structures such as the cervical region have also been studied in this area. It is believed that the anatomic proximity, neuronal interconnections and convergent afferents from the trigeminal and cervical areas can lead the understanding of the relationship of these structures. In order to assess the effects of these different forms of treatment studies have used different resources such as diagnostic imaging and biological signals, in order to complement the clinical diagnosis. Infrared thermography has been one of the resource assessment in the literature and it is interesting and stands out from other methods because it is functional, non-invasive and inexpensive.
Purpose: To evaluate the thermograms concerning the masseter and anterior temporal muscles, severity, pain, range of mandibular motion and neck disability in TMD patients, before and after physical therapy applied to the cervical and thoracic regions.
Methods: This is a randomized, placebo-controlled study, designed to evaluate the effects of indirect treatment on the thermography of the masticatory muscles, severity, pain, range of motion and neck disability in individuals with TMD. These will be randomized and allocated into two groups: GA (intervention) and GB (placebo) and assessed as: Diagnostic Criteria for Temporomandibular Research Disorders (RDC/TMD), Fonseca´s Anamnesic Index (FAI), Thermography, EVA, IDD-CF, Pachymetry and Neck Disability Index (NDI).
Statistical analysis: The temperature of the orofacial region, acquired through thermography is considered the primary endpoint and as a secondary endpoint will be the evaluation of the severity according to FAI, pain by VAS and IDD-CF, the range of mandibular motion by pachymetry and neck disability by NDI.
Statistical analysis: The normality of the data will be verified using the Kolmogorov-Smirnov test, which will be expressed as mean and standard deviation and/or median and interquartile range. Repeated measures analysis of variance of two factors, post hoc Bonferroni will be used for inter and intra-group comparisons. The significance level of p≤0.05 is set.
Detailed description
This is a randomized, placebo-controlled, study designed to evaluate the thermograms concerning the masseter and anterior temporal muscles, severity, pain, range of mandibular motion and neck disability in TMD patients, before and after physical therapy applied to the cervical and thoracic regions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy Treatment Group | Experimental | Other: Manual Therapy TreatmentSevere and Moderate TMD patients who filled the inclusion criteria who will receive the Manual Therapy Treatment |
| Placebo Ultrasound Treatment Group | Placebo comparator | Device: Placebo UltrasoundSevere and Moderate TMD patients who filled the inclusion criteria who will receive the Placebo Treatment. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 and 45 years;
- presence of pain in the facial region in the last 6 months;
- diagnosis of myofascial pain (I) and/or disc displacement (IIa and IIb) determined by the DRC/TMD; Moderate DTM Record carrier or determined by Fonseca Anamnesic Index.
Key exclusion criteria (11 listed)
- A history of trauma/cervical surgery and/or craniofacial;
- Neurological disorders;
- cervical disc disease;
- degenerative diseases of the spine;
- systemic diseases;
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 |
|---|---|---|
| Manual Therapy TreatmentTreatment starts with 10 deep breathing movements for global relaxation. The anterior and posterior neck muscles, shoulder girdle and subdiaphragmatic will be addressed with myofascial techniques repeated 10 times in each stroke. The cervical spine will be pulled in the longitudinal direction. The draw will be held 1 time, lasting 1 minute. The thoracic region will receive mobilization technique in the anteroposterior direction,10 repeated movements involving all thoracic segment. The treatment will be applied previously trained therapists, 4 weeks, 2 times a week, totaling eight sessions. The treatment time per session is about 25 minutes. | Other | Manual Therapy Treatment Group |
| Placebo UltrasoundA detuned pulsed ultrasound will be applied to regions of the muscles around the shoulder girdle and anterior posterior cervical, for 25 minutes (2.5 minutes in each zone ). The device will be used with the internal cables disconnected for the placebo effect . However, you can handle it and adjust the doses and alarms as it is connected in order to simulate clinical practice and increase the credibility of the use of this device in the voluntary . The placebo treatment will be applied by previously trained therapists. Treatment will have 4 weeks, 2 times a week, totaling eight sessions. | Device | Placebo Ultrasound Treatment Group |
Primary outcome
Changes in Skin Temperature
Time frame: Baseline and 4 weeks
Measured by the Infrared thermographic digital camera
5 secondary outcomes
Changes in TMD severity
Time frame: Baseline and 4 weeks
Changes in Neck disability
Time frame: Baseline and 4 weeks
Changes in Pain incapacity
Time frame: Baseline and 4 weeks
Changes in Movement Range of Motion (Opening)
Time frame: Baseline and 4 weeks
Changes in Referred Pain
Time frame: Baseline and 4 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 21 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Daniela Ap Biasotto-Gonzalez, PHD study chair
Study Principal Investigator - Universidade Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy Treatment in people with Temporomandibular Joint Dysfunction, run by Daniela Ap. Biasotto-Gonzalez 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 11 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 21 Feb 2022. 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. Some participants in this study may receive a placebo. 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?
Changes in Skin Temperature (time frame: Baseline and 4 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 21 Feb 2022.