Temporomandibular DisorderPhase 2TMDPBMTNCT03454581
Effectiveness of Photobiomodulation and Manual Therapy Alone or Combined in TMD Patients
A Phase 2 study testing Photobiomodulation and Manual Therapy (MT) in people with Temporomandibular Disorder, run by Federal University of Rio Grande do Sul.
Trial summary
The aim of the present study was to investigate the effect of photobiomodulation (PBM) and manual therapy (MT) isolated or combined in the reduce of pain, the improve of mandibular movements, the psychosocial aspects and the anxiety symptoms of patients with TMD. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- Photobiomodulation and Manual Therapy (MT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 17 May 2016to 14 Nov 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TMD myogenic and arthrogenic diagnosis based in RDC/TMD Axis I analysis
- Pain in temporomandibular joint (TMJ)
- Limitation in mouth opening.
Who cannot join
- Current dental or physical treatment
- Polyarthritis and other rheumatic diseases
- Use of anti-inflammatory and muscle relaxant
About this study
Official title: Comparative Effectiveness of Photobiomodulation and Manual Therapy Alone or Combined in TMD Patients: a Randomized Clinical Trial
The aim of the present study was to investigate the effect of photobiomodulation (PBM) and manual therapy (MT) isolated or combined in the reduce of pain, the improve of mandibular movements, the psychosocial aspects and the anxiety symptoms of patients with TMD.
Read the detailed description
Temporomandibular disorders (TMD) is a complex and multifactorial disease. Therapeutic modalities, as PBM and MT, expected to relief of symptoms, improve of function and reduce the impact of the disease in patient's life. Fifty-one TMD patients were randomly allocated to three groups: PBM group (n=18) using 808 nm, 100 milliwatt (mW), 13.3 J ∕cm2, 4 J per point), MT group (n=16) with 21 minutes sessions of MT of the masticatory muscles and TMJ and Combined Therapy group (CT) (n=17) applying the 2 protocol described above. All treatments were done three times a week for four consecutive weeks. Evaluations were performed at baseline, during the treatment (days 7, 14, 21, and 28) and follow up (day 60 and day 90). Visual analogue scale (VAS), Research Diagnostic Criteria (RDC/TMD) Axis I and II, Beck anxiety inventory (BAI) were used in different moments of evaluation time.
- Conditions
- Temporomandibular Disorder
- Being tested
- Photobiomodulation, Manual Therapy (MT)
- Keywords
- Temporomandibular Diseases, Photobiomodulation, Low level laser, Treatment, Manual Therapy
- 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.
PhotobiomodulationProcedure or surgery
Also called Low Level Laser (PBM)
PBM was applied, three times a week for four consecutive weeks at 5 points in the TMJ region: superior, anterior, lateral, posterior and postero inferior to the condyle. In addition, all patients received laser application in the temporal muscle (anterior, middle and posterior), in the masseter (upper, middle and lower portion) and insertion of the medial pterygoid.
Manual Therapy (MT)Procedure or surgery
Patients were submitted to MT at temporal, masseter and pterygoid medial from both sides, during 3 minutes each muscle group (Extraoral) and at masseter and lateral pterygoid (Intraoral) for 3 minutes, each total 21 minutes. MT on the TMJ region was performed for 1 minute and 3 repetitions during three times a week .
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation group (PBM) | Experimental | Gallium-aluminium-arsenide (GaAlAs) diode laser (MM Optics Recover, São Carlos, São Paulo, Brazil) with a wavelength of 808 nm, punctual contact mode,spot size of 0.03 cm2, power output of 100 mW, output density of 333 mW∕cm2, energy density of 13.3 J ∕cm2, 40 s exposure time per point, and 4 Joules (J) of total energy per point.
18 individuals Receives: Procedure: Photobiomodulation |
| Manual Therapy group (MT) | Experimental | At masticatory muscles were performed circular movements, slip and compression with fingers movements. At the temporomandibular joint (TMJ) was performed a caudal distraction with anterior projection, placing the thumb on the second or third molar.
16 individuals. Receives: Procedure: Manual Therapy (MT) |
| Combined therapy group (CT) | Experimental | Applied the protocols of PBM group and immediately after, to MT group. 17 individuals. Receives: Procedure: Photobiomodulation; Procedure: Manual Therapy (MT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Visual Analogic Scale (VAS) for Pain
Visual Analogic Score (VAS) is a psychometric scale used to measure subjective characteristics, as pain. Consists of a 100mm horizontal line with descriptors "no pain" at the initial point (score 0) and "worst pain" at the end point (score 100). To avoid clustering of scores, numbers or verbal descriptors at intermediate points are not recommended. Patients were asked to place a handwritten mark at one point along the 100mm line that best represents their pain intensity. The scores are recorded in millimeters and determined by the measurements from the initial point of the scale to the patients' mark, using a ruler. Higher scores indicate high levels of pain intensity. In this study, the scores (mm) of pain were recorded at days 7, 14, 21, 28, 60 and 90 and compared to the baseline score (day 0) to evaluate the response to each treatment.
Measured: 0,7,14,21,28,60,90 days
Secondary outcomes (7)
Change at Jaw Movements
Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Axis I was used to provide information of jaw movements. Using a caliper to assess mandibular range of motion (in millimeters), we measure mouth opening, right and left deviations and protrusion.
This questionnaire was applied at baseline (day 0), end of the treatment (day 28) and follow up (day 90).
Measured: 0,28,90 days
Change on Chronic Pain Grades
RDC/TMD Axis II includes measures from the Graded Chronic Pain Scale (GCPS). Participants rated on scales from 0 = "no pain" to 10 = "pain as bad as could be" their current pain and average and worst facial pain in the past six months. Also, on scales from 0 = "no interference" to 10 = "unable to carry on any activities" the degree of facial pain interference with daily activities in the past six months. The mean of the ratings, multiplied by 10, gives information on characteristic pain intensity (CPI) and daily disability. The GCP is based on CPI, number of disability days in the past six months and daily disability score classified as 0 = no pain, I = low CPI and disability, II = high CPI and low pain-related disability, III = moderate CPI and disability, and IV = severe CPI and disability. In this study, the number of participants, at the end of the study, with Low Incapacity (Grades 0 to I) and Higher Incapacity (Grades II to IV) was compared to the baseline numbers.
Measured: 0,90 days
Changes on Levels of Depression Symptoms
RDC/TMD Axis II is a validated questionnaire which assess the levels of depression symptoms (LDS). The participants answered 20 questions about how much they have been distressed to several symptoms of depression rating on a scale: 0 =Not at all; 1= A little bit; 2=Moderately; 3=Quite a bit; 4=Extremely. The total number of participants in the end of study, with no depression (scores 0 and 1 on the scale) and with moderate and severe depression (scores 2 to 4 on the scale) was compared to the baseline numbers (day 0).
Measured: 0,90 days
Change on Nonspecific Physical Symptoms With Pain
RDC/TMD Axis II can be used to provide information on nonspecific physical symptoms with pain. The participants rate the experiences in the past few weeks relative to "how usually feels" about several pain symptoms as follows: 0 =Not at all; 1= A little bit; 2=Moderately; 3=Quite a bit; 4=Extremely. We divided the participants into no symptoms ("Normal" = scores 0 to1 at the scale) and moderate/severe symptoms (scale 2 to 4 at the scale) and compared the total number of participants in each classification (No symptoms and Moderate/severe symptoms) at the end of the study to the baseline numbers.
Measured: 0, 90 days
Change on Nonspecific Physical Symptoms Without Pain
RDC/TMD Axis II is also used to provide information on nonspecific physical symptoms without pain. The participants rate the experiences in the past few weeks relative to "how usually feels" about several symptoms nonrelated to pain as follows: 0 =Not at all; 1= A little bit; 2=Moderately; 3=Quite a bit; 4=Extremely. We divided the participants in no symptoms ("Normal" =scores 0 to1 at the scale) and moderate/severe symptoms (scale 2 to 4 at the scale) and compared the total number of participants in each classification at the end of the study to the baseline numbers.
Measured: 0, 90 days
Changes on Mandibular Function
The changes at mandibular functions can be evaluated using the question 19 of RDC/TMD Axis II. Participants answered 0=No (no limitation due to jaw problem) or 1=Yes (the activity is limited by the jaw problem - worse outcome) to a list of activities that the jaw problem can limit from doing. The mean of all the "Yes" answers (score 1) for each group in the end of the study (day 90) was calculated and compared to the baseline means.
Measured: 0, 90 days
Changes on Levels of Anxiety
Beck anxiety inventory (BAI) is a validated questionnaire with 21 multiple-choice items addressing how much the patient has been bothered by common symptoms of anxiety, at the list in the previous week. Each answer is scored on a scale value of 0 = not at all , 1=Mildly, but it didn't bother me much, 2=Moderately - it wasn't pleasant at times and 3=Severely - it bothered me a lot. We applied the BAI in two moments of the study (baseline and at follow -up= day 90). In each moment the participants were classified using a score calculated by finding the sum of the 21 items. Score of 0-21 = low anxiety, Score of 22-35 = moderate anxiety, Score of 36 and above = high levels of anxiety. We presented the results using only the mean of BAI of participants of each group in that moment. We compared the mean of BAI among the groups (PBM X MT X combined groups- intergroup analysis) in the baseline and follow-up period. In addition, we also analyzed intragroup results comparing the mean of BAI.
Measured: 0,90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start17 May 2016
- Primary completion14 Nov 2016
- Study completion14 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Temporomandibular DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manoela Domingues Martins, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454581
- Sponsor's protocol ID
- PBM and MT TMD
- Acronym
- TMDPBMT
- Status last verified
- Aug 2019
- First submitted
- 5 Feb 2018
- Last updated
- 26 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Photobiomodulation and Manual Therapy Alone or Combined in TMD Patients: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03454581
- Acronym / sponsor ID
- TMDPBMT / PBM and MT TMD
- Conditions
- Temporomandibular Disorder
- Keywords
- Temporomandibular Diseases, Photobiomodulation, Low level laser, Treatment, Manual Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 17 May 2016 (actual)
- Primary completion
- 14 Nov 2016 (actual)
- Study completion
- 14 Nov 2016 (actual)
- First posted
- 6 Mar 2018 (actual)
- Results
- Posted 26 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study was to investigate the effect of photobiomodulation (PBM) and manual therapy (MT) isolated or combined in the reduce of pain, the improve of mandibular movements, the psychosocial aspects and the anxiety symptoms of patients with TMD.
Detailed description
Temporomandibular disorders (TMD) is a complex and multifactorial disease. Therapeutic modalities, as PBM and MT, expected to relief of symptoms, improve of function and reduce the impact of the disease in patient's life. Fifty-one TMD patients were randomly allocated to three groups: PBM group (n=18) using 808 nm, 100 milliwatt (mW), 13.3 J ∕cm2, 4 J per point), MT group (n=16) with 21 minutes sessions of MT of the masticatory muscles and TMJ and Combined Therapy group (CT) (n=17) applying the 2 protocol described above. All treatments were done three times a week for four consecutive weeks. Evaluations were performed at baseline, during the treatment (days 7, 14, 21, and 28) and follow up (day 60 and day 90). Visual analogue scale (VAS), Research Diagnostic Criteria (RDC/TMD) Axis I and II, Beck anxiety inventory (BAI) were used in different moments of evaluation time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation group (PBM) | Experimental | Procedure: PhotobiomodulationGallium-aluminium-arsenide (GaAlAs) diode laser (MM Optics Recover, São Carlos, São Paulo, Brazil) with a wavelength of 808 nm, punctual contact mode,spot size of 0.03 cm2, power output of 100 mW, output density of 333 mW∕cm2, energy density of 13.3 J ∕cm2, 40 s exposure time per point, and 4 Joules (J) of total energy per point. 18 individuals |
| Manual Therapy group (MT) | Experimental | Procedure: Manual Therapy (MT)At masticatory muscles were performed circular movements, slip and compression with fingers movements. At the temporomandibular joint (TMJ) was performed a caudal distraction with anterior projection, placing the thumb on the second or third molar. 16 individuals. |
| Combined therapy group (CT) | Experimental | Procedure: Photobiomodulation, Procedure: Manual Therapy (MT)Applied the protocols of PBM group and immediately after, to MT group. 17 individuals. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- TMD myogenic and arthrogenic diagnosis based in RDC/TMD Axis I analysis
- Pain in temporomandibular joint (TMJ)
- Limitation in mouth opening.
Key exclusion criteria (3 listed)
- Current dental or physical treatment
- Polyarthritis and other rheumatic diseases
- Use of anti-inflammatory and muscle relaxant
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 |
|---|---|---|
| PhotobiomodulationAlso: Low Level Laser (PBM)PBM was applied, three times a week for four consecutive weeks at 5 points in the TMJ region: superior, anterior, lateral, posterior and postero inferior to the condyle. In addition, all patients received laser application in the temporal muscle (anterior, middle and posterior), in the masseter (upper, middle and lower portion) and insertion of the medial pterygoid. | Procedure or surgery | Combined therapy group (CT), Photobiomodulation group (PBM) |
| Manual Therapy (MT)Patients were submitted to MT at temporal, masseter and pterygoid medial from both sides, during 3 minutes each muscle group (Extraoral) and at masseter and lateral pterygoid (Intraoral) for 3 minutes, each total 21 minutes. MT on the TMJ region was performed for 1 minute and 3 repetitions during three times a week . | Procedure or surgery | Combined therapy group (CT), Manual Therapy group (MT) |
Primary outcome
Change From Baseline in Visual Analogic Scale (VAS) for Pain
Time frame: 0,7,14,21,28,60,90 days
Visual Analogic Score (VAS) is a psychometric scale used to measure subjective characteristics, as pain. Consists of a 100mm horizontal line with descriptors "no pain" at the initial point (score 0) and "worst pain" at the end point (score 100). To avoid clustering of scores, numbers or verbal descriptors at intermediate points are not recommended. Patients were asked to place a handwritten mark at one point along the 100mm line that best represents their pain intensity. The scores are recorded in millimeters and determined by the measurements from the initial point of the scale to the patients' mark, using a ruler. Higher scores indicate high levels of pain intensity. In this study, the scores (mm) of pain were recorded at days 7, 14, 21, 28, 60 and 90 and compared to the baseline score (day 0) to evaluate the response to each treatment.
7 secondary outcomes
Change at Jaw Movements
Time frame: 0,28,90 days
Change on Chronic Pain Grades
Time frame: 0,90 days
Changes on Levels of Depression Symptoms
Time frame: 0,90 days
Change on Nonspecific Physical Symptoms With Pain
Time frame: 0, 90 days
Change on Nonspecific Physical Symptoms Without Pain
Time frame: 0, 90 days
Changes on Mandibular Function
Time frame: 0, 90 days
Changes on Levels of Anxiety
Time frame: 0,90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Photobiomodulation and Manual Therapy (MT) in people with Temporomandibular Disorder, run by Federal University of Rio Grande do Sul.
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 3 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 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
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?
Yes. Results are posted in the registry (first posted 26 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Visual Analogic Scale (VAS) for Pain (time frame: 0,7,14,21,28,60,90 days). 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 26 Sep 2019.