Temporomandibular Joint DisordersNCT02139735
Therapeutic Response of Ultrasound and Muscular Stretching in Temporomandibular Disorder Patients
A study testing Ultrasound and Ultrasound associated with stretching in people with Temporomandibular Joint Disorders, run by Universidade Federal de Santa Maria at 1 site in Brazil.
Trial summary
The combination of ultrasound and muscular stretching may have positive effects on pain relief and on the balance of the masticatory muscles activity. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Ultrasound and Ultrasound associated with stretching
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2012to Mar 2014
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis of myogenic or mixed TMD according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD)
- women aged 20 to 35 years.
Who cannot join
- psychomotor impairment ;
- history of orthopedic trauma involving the temporomandibular region , orofacial surgery or poor training ;
- analgesics , anti-inflammatories , muscle relaxants , antidepressants ;
- presence of acute TMJ pain ( last 3 months) ;
- have perform physical therapy or speech therapy for the past 6 months;
- periods of the end of the menstrual cycle (7 days prior to menstruation ) and onset of menstruation ( first 2 days ) were excluded for conducting evaluations of volunteers who did not use oral contraception and those who used it to break.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de Santa Maria
Santa Maria, Rio Grande do Sul, 97105-900
About this study
Official title: Therapeutic Response of Ultrasound and Muscular Stretching in Temporomandibular Disorder Patients: Clinical Trial
The combination of ultrasound and muscular stretching may have positive effects on pain relief and on the balance of the masticatory muscles activity.
Read the detailed description
This study aimed to evaluate the therapeutic response of ultrasound (US) and ultrasound associated with stretching of the masticatory muscles on the pressure pain threshold and the electrical activity of masseter and anterior temporal muscles in Temporomandibular Disorder (TMD) patients . The study included 18 women with TMD diagnosed by the instrument Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD). The pressure pain threshold, evaluated through algometry, and the electrical activity of the masticatory muscles were evaluated, by means of surface electromyography, before and immediately after the therapeutic procedures. The volunteers underwent three different interventions: ultrasound, ultrasound associated with stretching and ultrasound placebo, with a 1-week of minimum interval between them.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Ultrasound, Ultrasound associated with stretching, Placebo
- Keywords
- Temporomandibular Joint Disorders,, Ultrasonics,, Electromyography,, Pain Measurement,, Muscle Stretching Exercise
- 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.
UltrasoundOther
3 MHz ultrasound in continuous mode with an intensity of 1.0 W / cm ² was applied for 3 minutes in the TMJ and masseter muscles bilaterally
Ultrasound associated with stretchingOther
3 MHz ultrasound in continuous mode with an intensity of 1.0 W / cm ² was applied for 3 minutes in the TMJ and masseter muscles, bilaterally.
Active stretching of the masseter muscles with mouth opening and closed lips
PlaceboOther
Turned off ultrasound application on area of TMJ and masseter muscle, bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Experimental | 3 MHz (Mega Hertz) ultrasound in continuous mode with an intensity of 1.0 W / cm ² was applied for 3 minutes in the TMJ (Temporomandibular joint) and masseter muscles bilaterally Receives: Other: Ultrasound associated with stretching; Other: Placebo |
| Ultrasound associated with stretchting | Experimental | 3 MHz ultrasound in continuous mode with an intensity of 1.0 W / cm ² was applied for 3 minutes in the TMJ and masseter muscles bilaterally.
Active stretching of the masseter muscles with mouth opening and closed lips Receives: Other: Ultrasound; Other: Placebo |
| Placebo | Experimental | Turned off ultrasound application on area of TMJ and masseter muscle, bilaterally. Receives: Other: Ultrasound; Other: Ultrasound associated with stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
pressure pain threshold
algometry
Measured: 10 minutes
Secondary outcomes (1)
surface electromyography
electromyographic activity was measure at rest, in maximal intercuspal position and maximal voluntary clench
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startMar 2012
- Primary completionJun 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Maria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eliane Correa, Universidade Federal de Santa Maria
- Investigators
- Eliane C. Corrêa, Doctor, Principal investigator, Universidade Federal de Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139735
- Sponsor's protocol ID
- UFSM-MO-01
- Status last verified
- May 2014
- First submitted
- 9 May 2014
- Last updated
- 15 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Response of Ultrasound and Muscular Stretching in Temporomandibular Disorder Patients: Clinical Trial
- ClinicalTrials.gov ID
- NCT02139735
- Acronym / sponsor ID
- UFSM-MO-01
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- Temporomandibular Joint Disorders,, Ultrasonics,, Electromyography,, Pain Measurement,, Muscle Stretching Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universidade Federal de Santa MariaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 15 May 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 combination of ultrasound and muscular stretching may have positive effects on pain relief and on the balance of the masticatory muscles activity.
Detailed description
This study aimed to evaluate the therapeutic response of ultrasound (US) and ultrasound associated with stretching of the masticatory muscles on the pressure pain threshold and the electrical activity of masseter and anterior temporal muscles in Temporomandibular Disorder (TMD) patients . The study included 18 women with TMD diagnosed by the instrument Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD). The pressure pain threshold, evaluated through algometry, and the electrical activity of the masticatory muscles were evaluated, by means of surface electromyography, before and immediately after the therapeutic procedures. The volunteers underwent three different interventions: ultrasound, ultrasound associated with stretching and ultrasound placebo, with a 1-week of minimum interval between them.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Experimental | Other: Ultrasound associated with stretching, Other: Placebo3 MHz (Mega Hertz) ultrasound in continuous mode with an intensity of 1.0 W / cm ² was applied for 3 minutes in the TMJ (Temporomandibular joint) and masseter muscles bilaterally |
| Ultrasound associated with stretchting | Experimental | Other: Ultrasound, Other: Placebo3 MHz ultrasound in continuous mode with an intensity of 1.0 W / cm ² was applied for 3 minutes in the TMJ and masseter muscles bilaterally. Active stretching of the masseter muscles with mouth opening and closed lips |
| Placebo | Experimental | Other: Ultrasound, Other: Ultrasound associated with stretchingTurned off ultrasound application on area of TMJ and masseter muscle, bilaterally. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- diagnosis of myogenic or mixed TMD according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD)
- women aged 20 to 35 years.
Key exclusion criteria (6 listed)
- psychomotor impairment ;
- history of orthopedic trauma involving the temporomandibular region , orofacial surgery or poor training ;
- analgesics , anti-inflammatories , muscle relaxants , antidepressants ;
- presence of acute TMJ pain ( last 3 months) ;
- have perform physical therapy or speech therapy for the past 6 months;
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 |
|---|---|---|
| Ultrasound3 MHz ultrasound in continuous mode with an intensity of 1.0 W / cm ² was applied for 3 minutes in the TMJ and masseter muscles bilaterally | Other | Placebo, Ultrasound associated with stretchting |
| Ultrasound associated with stretching3 MHz ultrasound in continuous mode with an intensity of 1.0 W / cm ² was applied for 3 minutes in the TMJ and masseter muscles, bilaterally. Active stretching of the masseter muscles with mouth opening and closed lips | Other | Placebo, Ultrasound |
| PlaceboTurned off ultrasound application on area of TMJ and masseter muscle, bilaterally. | Other | Ultrasound, Ultrasound associated with stretchting |
Primary outcome
pressure pain threshold
Time frame: 10 minutes
algometry
1 secondary outcome
surface electromyography
Time frame: 10 minutes
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 15 May 2014.
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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.
Eliane C. Corrêa, Doctor principal investigator
Universidade Federal de Santa Maria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound and Ultrasound associated with stretching in people with Temporomandibular Joint Disorders, run by Universidade Federal de Santa Maria 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 2 inclusion and 6 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 15 May 2014. 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?
pressure pain threshold (time frame: 10 minutes). 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 15 May 2014.