TMDPBMT: Effectiveness of Photobiomodulation and Manual Therapy Alone or Combined in TMD Patients

• Sponsor: Federal University of Rio Grande do Sul (Other)
• Overall Status: Completed
• CT.gov ID: NCT03454581
• Collaborator: (none)
• Enrollment: 51
• Arms: 3
• Actual Duration (Months): 5.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Temporomandibular Disorder	Procedure: Photobiomodulation; Procedure: Manual Therapy (MT)	Phase 2

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

• Study Type: Interventional
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparative Effectiveness of Photobiomodulation and Manual Therapy Alone or Combined in TMD Patients: a Randomized Clinical Trial
• Actual Study Start Date: May 17, 2016
• Actual Primary Completion Date: Nov 14, 2016
• Actual Study Completion Date: Nov 14, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Photobiomodulation group (PBM) 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	Procedure: Photobiomodulation; 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.; Other Names: Low Level Laser (PBM)
Experimental: Manual Therapy group (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.	Procedure: 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 .
Experimental: Combined therapy group (CT) Applied the protocols of PBM group and immediately after, to MT group. 17 individuals.	Procedure: Photobiomodulation; 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.; Other Names: Low Level Laser (PBM) ; Procedure: 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 .

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Visual Analogic Scale (VAS) for Pain [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.

Secondary Outcome Measures

1. Change at Jaw Movements [0,28,90 days]

   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).

2. Change on Chronic Pain Grades [0,90 days]

   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.

3. Changes on Levels of Depression Symptoms [0,90 days]

   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).

4. Change on Nonspecific Physical Symptoms With Pain [0, 90 days]

   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.

5. Change on Nonspecific Physical Symptoms Without Pain [0, 90 days]

   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.

6. Changes on Mandibular Function [0, 90 days]

   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.

7. Changes on Levels of Anxiety [0,90 days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• TMD myogenic and arthrogenic diagnosis based in RDC/TMD Axis I analysis

• Pain in temporomandibular joint (TMJ)

• Limitation in mouth opening.

Exclusion Criteria:

• Current dental or physical treatment

• Polyarthritis and other rheumatic diseases

• Use of anti-inflammatory and muscle relaxant

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Federal University of Rio Grande do Sul

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Manoela Domingues Martins, Associate Professor, Federal University of Rio Grande do Sul
• ClinicalTrials.gov Identifier: NCT03454581
• Other Study ID Numbers: PBM and MT TMD
• First Posted: Mar 6, 2018
• Last Update Posted: Sep 26, 2019
• Last Verified: Aug 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Manoela Domingues Martins, Associate Professor, Federal University of Rio Grande do Sul: Temporomandibular Diseases; Photobiomodulation; Low level laser; Treatment; Manual Therapy
• Additional relevant MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome

Study Results

Participant Flow

Recruitment Details	Recruitment and follow-up assessment: May 2016 to November 2016. Location: Participants were recruited from patients referred to the Department of Buco Maxillofacial Surgery and Traumatology and to the Department of Conservative Dentistry at Federal University of Rio Grande do Sul, Porto Alegre,Brazil.
Pre-assignment Detail	Fifty-one participants were enrolled and randomized into 3 groups. Inclusion criteria: myogenic and arthrogenic temporomandibular dysfunction, pain and mouth movement limitation. Exclusion criteria: Dental therapy; rheumatic diseases, use of anti-inflammatory and muscle relaxant.

Arm/Group Title	Photobiomodulation Group	Manual Therapy Group (MT)	Combined Therapy Group (CT)
Arm/Group Description	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 100mW (megawatts), 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 Photobiomodulation: 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.	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. 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 .	Applied the protocols of photobiomodulation group and immediately after, to MT group. 17 individuals.
Period Title: Overall Study
STARTED	18	16	17
COMPLETED	14	13	14
NOT COMPLETED	4	3	3

Baseline Characteristics

Arm/Group Title	Photobiomodulation Group (PBM)	Manual Therapy Group (MT)	Combined Therapy Group (CT)	Total
Arm/Group Description	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.	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 .	Applied the protocols of PBM group and immediately after, to MT group. .	Total of all reporting groups
Overall Participants	18	16	17	51
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.29 (14.43)	42.44 (17.45)	41.65 (19.46)	43.48 (17.01)
Sex: Female, Male (Count of Participants)
Female	18 100%	15 93.8%	16 94.1%	49 96.1%
Male	0 0%	1 6.3%	1 5.9%	2 3.9%
Duration of pain (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	8.8 (6.9)	10.1 (12.8)	9.2 (9)	9.4 (9.9)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Visual Analogic Scale (VAS) for Pain
Description	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.
Time Frame	0,7,14,21,28,60,90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photobiomodulation Group	Manual Therapy Group (MT)	Combined Therapy Group (CT)
Arm/Group Description	Gallium-aluminium-arsenide (GaAlAs) diode laser with a wavelength of 808 nm was applied, three times a week for four consecutive weeks at TMJ, temporal muscle, masseter and insertion of the medial pterygoid.	Patients were submitted to circular movements at temporal, masseter and pterygoid medial (Extraoral) and at masseter and lateral pterygoid (Intraoral) during three times a week for 4 weeks. In addition, an articular manipulation at TMJ was performed.	Applied the protocols of photobiomodulation group and immediately after, to MT group.
Measure Participants	14	13	14
Baseline	4.1	4.4	5.2
Day 7	3.3	2.8	3.4
Day14	1.9	1.7	2.4
Day 21	1.8	0.5	1.9
Day 28	1.1	1.3	0.9
Day 60	0.8	0.6	1.2
Day 90	1.6	0.9	1.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Photobiomodulation Group, Manual Therapy Group (MT), Combined Therapy Group (CT)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change at Jaw Movements
Description	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).
Time Frame	0,28,90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photobiomodulation Group	Manual Therapy Group (MT)	Combined Therapy Group (CT)
Arm/Group Description	Gallium-aluminium-arsenide (GaAlAs) diode laser with a wavelength of 808 nm was applied, three times a week for four consecutive weeks at TMJ, temporal muscle, masseter and insertion of the medial pterygoid.	Patients were submitted to circular movements at temporal, masseter and pterygoid medial (Extraoral) and at masseter and lateral pterygoid (Intraoral) during three times a week for 4 weeks. In addition, an articular manipulation at TMJ was performed.	Applied the protocols of photobiomodulation group and immediately after, to MT group.
Measure Participants	14	13	14
Opening - Day 0	29.64	27.92	29.71
Opening - Day 28	35.27	34.00	31.50
Opening - Day 90	36.86	33.38	31.93
Maximum opening - day 0	40.86	38.46	35.29
Maximum opening - day 28	42.79	41.85	38.93
Maximum opening - day 90	44.50	42.54	39.93
Right excursion - day 0	5.93	6.31	6.57
Right excursion - day 28	8.36	8.62	6.64
Right excursion - day 90	7.90	8.31	7.36

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Photobiomodulation Group, Manual Therapy Group (MT), Combined Therapy Group (CT)
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Generalized Estimating Equation
	Comments

3. Secondary Outcome

Title	Change on Chronic Pain Grades
Description	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.
Time Frame	0,90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photobiomodulation Group	Manual Therapy Group (MT)	Combined Therapy Group (CT)
Arm/Group Description	Gallium-aluminium-arsenide (GaAlAs) diode laser with a wavelength of 808 nm was applied, three times a week for four consecutive weeks at TMJ, temporal muscle, masseter and insertion of the medial pterygoid.	Patients were submitted to circular movements at temporal, masseter and pterygoid medial (Extraoral) and at masseter and lateral pterygoid (Intraoral) during three times a week for 4 weeks. In addition, an articular manipulation at TMJ was performed.	Applied the protocols of photobiomodulation group and immediately after, to MT group.
Measure Participants	14	13	14
Low Incapacity	10 55.6%	12 75%	7 41.2%
High Incapacity	4 22.2%	1 6.3%	7 41.2%
Low Incapacity	13 72.2%	13 81.3%	8 47.1%
High Incapacity	1 5.6%	0 0%	6 35.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Photobiomodulation Group, Manual Therapy Group (MT), Combined Therapy Group (CT)
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Generalized Estimating Equation
	Comments

4. Secondary Outcome

Title	Changes on Levels of Depression Symptoms
Description	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).
Time Frame	0,90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photobiomodulation Group	Manual Therapy Group (MT)	Combined Therapy Group (CT)
Arm/Group Description	Gallium-aluminium-arsenide (GaAlAs) diode laser with a wavelength of 808 nm was applied, three times a week for four consecutive weeks at TMJ, temporal muscle, masseter and insertion of the medial pterygoid.	Patients were submitted to circular movements at temporal, masseter and pterygoid medial (Extraoral) and at masseter and lateral pterygoid (Intraoral) during three times a week for 4 weeks. In addition, an articular manipulation at TMJ was performed.	Applied the protocols of photobiomodulation group and immediately after, to MT group.
Measure Participants	14	13	14
No depression	6 33.3%	7 43.8%	3 17.6%
Moderate/Severe depression	8 44.4%	6 37.5%	11 64.7%
No depression	11 61.1%	9 56.3%	9 52.9%
Moderate/Severe depression	3 16.7%	4 25%	5 29.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Photobiomodulation Group, Manual Therapy Group (MT), Combined Therapy Group (CT)
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Generalized Estimating Equation
	Comments

5. Secondary Outcome

Title	Change on Nonspecific Physical Symptoms With Pain
Description	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.
Time Frame	0, 90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photobiomodulation Group	Manual Therapy Group (MT)	Combined Therapy Group (CT)
Arm/Group Description	Gallium-aluminium-arsenide (GaAlAs) diode laser with a wavelength of 808 nm was applied, three times a week for four consecutive weeks at TMJ, temporal muscle, masseter and insertion of the medial pterygoid.	Patients were submitted to circular movements at temporal, masseter and pterygoid medial (Extraoral) and at masseter and lateral pterygoid (Intraoral) during three times a week for 4 weeks. In addition, an articular manipulation at TMJ was performed.	Applied the protocols of photobiomodulation group and immediately after, to MT group. .
Measure Participants	14	13	14
Normal	3 16.7%	5 31.3%	2 11.8%
Moderate/Severe symptoms	11 61.1%	8 50%	12 70.6%
Normal	7 38.9%	10 62.5%	6 35.3%
Moderate/Severe symptoms	7 38.9%	3 18.8%	8 47.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Photobiomodulation Group, Manual Therapy Group (MT), Combined Therapy Group (CT)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Generalized Estimating Equation
	Comments

6. Secondary Outcome

Title	Change on Nonspecific Physical Symptoms Without Pain
Description	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.
Time Frame	0, 90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photobiomodulation Group	Manual Therapy Group (MT)	Combined Therapy Group (CT)
Arm/Group Description	Gallium-aluminium-arsenide (GaAlAs) diode laser with a wavelength of 808 nm was applied, three times a week for four consecutive weeks at TMJ, temporal muscle, masseter and insertion of the medial pterygoid.	Patients were submitted to circular movements at temporal, masseter and pterygoid medial (Extraoral) and at masseter and lateral pterygoid (Intraoral) during three times a week for 4 weeks. In addition, an articular manipulation at TMJ was performed.	Applied the protocols of photobiomodulation group and immediately after, to MT group. .
Measure Participants	14	13	14
Normal	5 27.8%	6 37.5%	2 11.8%
Moderate/Severe symptoms	9 50%	7 43.8%	12 70.6%
Normal	8 44.4%	11 68.8%	8 47.1%
Moderate/Severe symptoms	6 33.3%	2 12.5%	6 35.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Photobiomodulation Group, Manual Therapy Group (MT), Combined Therapy Group (CT)
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Generalized Estimating Equation
	Comments

7. Secondary Outcome

Title	Changes on Mandibular Function
Description	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.
Time Frame	0, 90 days

Outcome Measure Data

Analysis Population Description

To the Analysis of Population, we used the mean and the confidence interval of scores of all participants from each group.

Arm/Group Title	Photobiomodulation Group	Manual Therapy Group (MT)	Combined Therapy Group (CT)
Arm/Group Description	Gallium-aluminium-arsenide (GaAlAs) diode laser with a wavelength of 808 nm was applied, three times a week for four consecutive weeks at TMJ, temporal muscle, masseter and insertion of the medial pterygoid.	Patients were submitted to circular movements at temporal, masseter and pterygoid medial (Extraoral) and at masseter and lateral pterygoid (Intraoral) during three times a week for 4 weeks. In addition, an articular manipulation at TMJ was performed.	Applied the protocols of photobiomodulation group and immediately after, to MT group.
Measure Participants	14	13	14
Chewing - day 0	0.5	0.85	0.93
Chewing - day 90	0.29	0.38	0.57
Exercising - day 0	0.07	0.08	0.50
Exercising - day 90	0.00	0.08	0.07
Eating hard foods - day 0	0.71	0.85	0.36
Eating hard foods - day 90	0.43	0.54	0.71
Eating soft foods - day 0	0.07	0.23	0.36
Eating soft foods - day 90	0.00	0.00	0.14
Smiling - day 0	0.36	0.31	0.50
Smiling - day 90	0.07	0.08	0.36
Swallowing - day 0	0.14	0.23	0.43
Swallowing - day 90	0.07	0.00	0.21

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Photobiomodulation Group, Manual Therapy Group (MT), Combined Therapy Group (CT)
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Generalized Estimating Equation
	Comments

8. Secondary Outcome

Title	Changes on Levels of Anxiety
Description	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.
Time Frame	0,90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photobiomodulation Group	Manual Therapy Group (MT)	Combined Therapy Group (CT)
Arm/Group Description	Gallium-aluminium-arsenide (GaAlAs) diode laser with a wavelength of 808 nm was applied, three times a week for four consecutive weeks at TMJ, temporal muscle, masseter and insertion of the medial pterygoid.	Patients were submitted to circular movements at temporal, masseter and pterygoid medial (Extraoral) and at masseter and lateral pterygoid (Intraoral) during three times a week for 4 weeks. In addition, an articular manipulation at TMJ was performed.	Applied the protocols of photobiomodulation group and immediately after, to MT group.
Measure Participants	14	13	14
Day 0	17.86	14.92	31.21
Day 90	9.57	7.92	13.57

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Photobiomodulation Group, Manual Therapy Group (MT), Combined Therapy Group (CT)
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Generalized Estimating Equation
	Comments

Adverse Events

Arm/Group Title	Photobiomodulation Group (PBM)		Manual Therapy Group (MT)		Combined Therapy Group (CT)
Arm/Group Description	Gallium-aluminium-arsenide (GaAlAs) diode laser with a wavelength of 808 nm was applied, three times a week for four consecutive weeks at TMJ, temporal muscle, masseter and insertion of the medial pterygoid.		Patients were submitted to circular movements at temporal, masseter and pterygoid medial (Extraoral) and at masseter and lateral pterygoid (Intraoral) during three times a week for 4 weeks. In addition, an articular manipulation at TMJ was performed.		Applied the protocols of PBM group and immediately after, to MT group.
All Cause Mortality
	Photobiomodulation Group (PBM)		Manual Therapy Group (MT)		Combined Therapy Group (CT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Photobiomodulation Group (PBM)		Manual Therapy Group (MT)		Combined Therapy Group (CT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/13 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Photobiomodulation Group (PBM)		Manual Therapy Group (MT)		Combined Therapy Group (CT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/13 (0%)		0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.