Temporomandibular Disorder.Phase 1/2NCT02018770
Effect of Phototherapy in Individuals With Temporomandibular Disorder.
A Phase 1/2 study testing Phototherapy in people with Temporomandibular Disorder., run by University of Nove de Julho at 1 site in Brazil.
Trial summary
The present study aims to evaluate the effect of phototherapy with the combination of different sources of light on pain, activity of temporal and masseter muscles, bilateral and joint mobility in subjects with TMD. It will be made a randomized, placebo-controlled and double-blind clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Temporomandibular Disorder.
- What is being tested?
- Phototherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2014to Dec 2014
- Phase
- Phase 1/2
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 40 years.
- Female volunteers.
- Diagnosis of myogenic TMD pain must masseter presenting moderate to severe according to the RDC / TMD.
- Display body mass index (BMI) less than 25 kg/m2 to standardize the sample.
- In addition, volunteers must submit scores of pain greater than 3 cm according to the Visual Analog Scale masticatory muscles.
Who cannot join
- history of neurological disorders.
- chronic neck pain resulting from a traumatic incident.
- chronic musculoskeletal condition.
- medical diagnosis of fibromyalgia; systemic disease.
- connective tissue disorder.
- having undergone physical therapy use of analgesic, muscle relaxant.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Nove de Julho
São Paulo, São Paulo, 01415000
Daniela Ap Biasotto-Gonzalez, Doctor, +5511999063166, dani_atm@ig.com.br
About this study
Official title: Effect of Phototherapy on Pain, Muscles Activity and Joint Mobility in Individuals With Temporomandibular Disorder: A Randomized, Placebo-Controlled and Double-Blind Clinical Trial.
The present study aims to evaluate the effect of phototherapy with the combination of different sources of light on pain, activity of temporal and masseter muscles, bilateral and joint mobility in subjects with TMD. It will be made a randomized, placebo-controlled and double-blind clinical trial. Individuals participate with myogenic temporomandibular disorder, being allocated into 4 groups randomly and stratified by the method of sealed envelopes. The results will be evaluated using: RDC/TMD, digital caliper, electromyography, and visual analog scale and algometry. The protocols will be used in a single session and will be evaluated in four different moments. The variables that will be investigated are pain, muscle activity and joint mobility. The analyses of the data will be performed by adopting a significance level of 5%.
- Conditions
- Temporomandibular Disorder.
- Being tested
- Phototherapy, Placebo phototherapy
- Keywords
- Temporomandibular Disorders, Electromyogram,, Modalities of physiotherapy,, Temporomandibular dysfunction syndrome,, Lasers.
- 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.
PhototherapyRadiation
Portable Cluster 9 PainAway ® diodes manufactured by Multi Radiance Medical ® (Solon, OH-USA), being 1 905 nm diode (1 mW average power 10 W of peak power, spot of 0.44 cm2), 875 nm diodes 4 (17.5 mW average power for each diode, spot of 1 cm2) and 670 nm diodes 4 (15 mW average power for each diode1 spot, cm2), frequency of 1000 Hz, irradiation time of 300 seconds, energy delivered from 39.3 Joules.
Placebo phototherapyRadiation
The volunteers will be subjected to the same Groups ' intervention and placebo pen Phototherapy.
| Study group | Role | What they receive |
|---|---|---|
| Phototherapy | Experimental | Three groups will receive different fototerapia of light sources, and group 1 will not receive dose: Group A (0, 65Joules), Group B (1.30 Joules) and Group C (1.95 Joules) . Receives: Radiation: Phototherapy |
| Placebo phototherapy | Placebo comparator | The volunteers will be subjected to the same Groups intervention Phototherapy . The but researcher will receive placebo pen. It is the caveat that, after completed the voluntary participation, will be held with the active pen treatment. Receives: Radiation: Placebo phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity.
Will be used a algometry D-200 of Instrutherm ®, which is a semi quantitative method to measure the intensity of the pain by the pressure, find painful spots, in addition to quantify changes the various pain syndromes.
Measured: 1 year
Secondary outcomes (1)
Electromyographic activity
The electrical powers of masticatory muscles will be verified in this study through surface electromyography, specifically the masseter and temporal muscles, serving as a useful tool to quantify muscle activity during Mastication and thus identify its functional changes.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionSep 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Disorder.Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Ap. Biasotto-Gonzalez, University of Nove de Julho
- Investigators
- Daniela Ap Biasotto-Gonzalez, Doctor, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018770
- Sponsor's protocol ID
- 18032013.4.0000.5511
- Status last verified
- Jan 2014
- First submitted
- 17 Dec 2013
- Last updated
- 11 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Herpich CM, Leal-Junior ECP, Gomes CAFP, Gloria IPDS, Amaral AP, Amaral MFRS, Politti F, Biasotto-Gonzalez DA. Immediate and short-term effects of phototherapy on pain, muscle activity, and joint mobility in women with temporomandibular disorder: a randomized, double-blind, placebo-controlled, clinical trial. Disabil Rehabil. 2018 Sep;40(19):2318-2324. doi: 10.1080/09638288.2017.1336648. Epub 2017 Jun 11.
PubMed 28602137Herpich CM, Leal-Junior EC, Amaral AP, Tosato Jde P, Gloria IP, Garcia MB, Barbosa BR, El Hage Y, Arruda EE, Gomes CA, Rodrigues MS, de Sousa DF, de Carvalho Pde T, Bussadori SK, Gonzalez Tde O, Politti F, Biasotto-Gonzalez DA. Effects of phototherapy on muscle activity and pain in individuals with temporomandibular disorder: a study protocol for a randomized controlled trial. Trials. 2014 Dec 16;15:491. doi: 10.1186/1745-6215-15-491.
PubMed 25514875
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Phototherapy on Pain, Muscles Activity and Joint Mobility in Individuals With Temporomandibular Disorder: A Randomized, Placebo-Controlled and Double-Blind Clinical Trial.
- ClinicalTrials.gov ID
- NCT02018770
- Acronym / sponsor ID
- 18032013.4.0000.5511
- Conditions
- Temporomandibular Disorder.
- Keywords
- Temporomandibular Disorders, Electromyogram,, Modalities of physiotherapy,, Temporomandibular dysfunction syndrome,, Lasers.
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 23 Dec 2013 (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 present study aims to evaluate the effect of phototherapy with the combination of different sources of light on pain, activity of temporal and masseter muscles, bilateral and joint mobility in subjects with TMD. It will be made a randomized, placebo-controlled and double-blind clinical trial. Individuals participate with myogenic temporomandibular disorder, being allocated into 4 groups randomly and stratified by the method of sealed envelopes. The results will be evaluated using: RDC/TMD, digital caliper, electromyography, and visual analog scale and algometry. The protocols will be used in a single session and will be evaluated in four different moments. The variables that will be investigated are pain, muscle activity and joint mobility. The analyses of the data will be performed by adopting a significance level of 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phototherapy | Experimental | Radiation: PhototherapyThree groups will receive different fototerapia of light sources, and group 1 will not receive dose: Group A (0, 65Joules), Group B (1.30 Joules) and Group C (1.95 Joules) . |
| Placebo phototherapy | Placebo comparator | Radiation: Placebo phototherapyThe volunteers will be subjected to the same Groups intervention Phototherapy . The but researcher will receive placebo pen. It is the caveat that, after completed the voluntary participation, will be held with the active pen treatment. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18 to 40 years.
- Female volunteers.
- Diagnosis of myogenic TMD pain must masseter presenting moderate to severe according to the RDC / TMD.
- Display body mass index (BMI) less than 25 kg/m2 to standardize the sample.
- In addition, volunteers must submit scores of pain greater than 3 cm according to the Visual Analog Scale masticatory muscles.
Key exclusion criteria (6 listed)
- history of neurological disorders.
- chronic neck pain resulting from a traumatic incident.
- chronic musculoskeletal condition.
- medical diagnosis of fibromyalgia; systemic disease.
- connective tissue disorder.
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 |
|---|---|---|
| PhototherapyPortable Cluster 9 PainAway ® diodes manufactured by Multi Radiance Medical ® (Solon, OH-USA), being 1 905 nm diode (1 mW average power 10 W of peak power, spot of 0.44 cm2), 875 nm diodes 4 (17.5 mW average power for each diode, spot of 1 cm2) and 670 nm diodes 4 (15 mW average power for each diode1 spot, cm2), frequency of 1000 Hz, irradiation time of 300 seconds, energy delivered from 39.3 Joules. | Radiation | Phototherapy |
| Placebo phototherapyThe volunteers will be subjected to the same Groups ' intervention and placebo pen Phototherapy. | Radiation | Placebo phototherapy |
Primary outcome
Pain intensity.
Time frame: 1 year
Will be used a algometry D-200 of Instrutherm ®, which is a semi quantitative method to measure the intensity of the pain by the pressure, find painful spots, in addition to quantify changes the various pain syndromes.
1 secondary outcome
Electromyographic activity
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2014.
- Derived from this study: PubMed 28602137Herpich CM, Leal-Junior ECP, Gomes CAFP, Gloria IPDS, Amaral AP, Amaral MFRS, Politti F, Biasotto-Gonzalez DA. Immediate and short-term effects of phototherapy on pain, muscle activity, and joint mobility in women with temporomandibular disorder: a randomized, double-blind, placebo-controlled, clinical trial. Disabil Rehabil. 2018 Sep;40(19):2318-2324. doi: 10.1080/09638288.2017.1336648. Epub 2017 Jun 11.
- Derived from this study: PubMed 25514875Herpich CM, Leal-Junior EC, Amaral AP, Tosato Jde P, Gloria IP, Garcia MB, Barbosa BR, El Hage Y, Arruda EE, Gomes CA, Rodrigues MS, de Sousa DF, de Carvalho Pde T, Bussadori SK, Gonzalez Tde O, Politti F, Biasotto-Gonzalez DA. Effects of phototherapy on muscle activity and pain in individuals with temporomandibular disorder: a study protocol for a randomized controlled trial. Trials. 2014 Dec 16;15:491. doi: 10.1186/1745-6215-15-491.
- URL of the University of Nove de JulhoLink provided by the sponsor.
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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, Doctor principal investigator
University of 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 Phase 1/2 study testing Phototherapy in people with Temporomandibular Disorder., run by University of Nove de Julho 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 5 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: status not confirmed, as of the sponsor's last update on 11 Mar 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. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02018770, which also lists 2 linked publications.
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 11 Mar 2014.