Trial Outcomes & Findings for Effectiveness of Photobiomodulation and Manual Therapy Alone or Combined in TMD Patients (NCT NCT03454581)
NCT ID: NCT03454581
Last Updated: 2019-09-26
Results Overview
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.
COMPLETED
PHASE2
51 participants
0,7,14,21,28,60,90 days
2019-09-26
Participant Flow
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.
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.
Participant milestones
| Measure |
Photobiomodulation Group
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.
|
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.
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 .
|
Combined Therapy Group (CT)
Applied the protocols of photobiomodulation group and immediately after, to MT group.
17 individuals.
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
16
|
17
|
|
Overall Study
COMPLETED
|
14
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Photobiomodulation and Manual Therapy Alone or Combined in TMD Patients
Baseline characteristics by cohort
| Measure |
Photobiomodulation Group (PBM)
n=18 Participants
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 Group (MT)
n=16 Participants
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 .
|
Combined Therapy Group (CT)
n=17 Participants
Applied the protocols of PBM group and immediately after, to MT group.
.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.29 years
STANDARD_DEVIATION 14.43 • n=5 Participants
|
42.44 years
STANDARD_DEVIATION 17.45 • n=7 Participants
|
41.65 years
STANDARD_DEVIATION 19.46 • n=5 Participants
|
43.48 years
STANDARD_DEVIATION 17.01 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Duration of pain
|
8.8 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
10.1 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
9.2 years
STANDARD_DEVIATION 9 • n=5 Participants
|
9.4 years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
PRIMARY outcome
Timeframe: 0,7,14,21,28,60,90 daysVisual 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.
Outcome measures
| Measure |
Photobiomodulation Group
n=14 Participants
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.
|
Manual Therapy Group (MT)
n=13 Participants
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.
|
Combined Therapy Group (CT)
n=14 Participants
Applied the protocols of photobiomodulation group and immediately after, to MT group.
|
|---|---|---|---|
|
Change From Baseline in Visual Analogic Scale (VAS) for Pain
Baseline
|
4.1 millimeters
Interval 2.91 to 5.36
|
4.4 millimeters
Interval 2.46 to 6.31
|
5.2 millimeters
Interval 3.75 to 6.61
|
|
Change From Baseline in Visual Analogic Scale (VAS) for Pain
Day 7
|
3.3 millimeters
Interval 1.89 to 4.68
|
2.8 millimeters
Interval 1.51 to 4.03
|
3.4 millimeters
Interval 2.23 to 4.49
|
|
Change From Baseline in Visual Analogic Scale (VAS) for Pain
Day14
|
1.9 millimeters
Interval 1.1 to 2.76
|
1.7 millimeters
Interval 0.71 to 2.68
|
2.4 millimeters
Interval 1.72 to 3.13
|
|
Change From Baseline in Visual Analogic Scale (VAS) for Pain
Day 21
|
1.8 millimeters
Interval 0.77 to 2.8
|
0.5 millimeters
Interval 0.03 to 1.04
|
1.9 millimeters
Interval 1.12 to 2.59
|
|
Change From Baseline in Visual Analogic Scale (VAS) for Pain
Day 28
|
1.1 millimeters
Interval 0.43 to 1.71
|
1.3 millimeters
Interval 0.17 to 2.44
|
0.9 millimeters
Interval 0.43 to 1.43
|
|
Change From Baseline in Visual Analogic Scale (VAS) for Pain
Day 60
|
0.8 millimeters
Interval 0.19 to 1.39
|
0.6 millimeters
Interval 0.16 to 1.07
|
1.2 millimeters
Interval 0.72 to 1.71
|
|
Change From Baseline in Visual Analogic Scale (VAS) for Pain
Day 90
|
1.6 millimeters
Interval 0.96 to 2.27
|
0.9 millimeters
Interval 0.17 to 1.66
|
1.9 millimeters
Interval 0.79 to 2.92
|
SECONDARY outcome
Timeframe: 0,28,90 daysResearch 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).
Outcome measures
| Measure |
Photobiomodulation Group
n=14 Participants
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.
|
Manual Therapy Group (MT)
n=13 Participants
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.
|
Combined Therapy Group (CT)
n=14 Participants
Applied the protocols of photobiomodulation group and immediately after, to MT group.
|
|---|---|---|---|
|
Change at Jaw Movements
Opening - Day 0
|
29.64 millimeters
Interval 27.17 to 32.35
|
27.92 millimeters
Interval 24.97 to 31.23
|
29.71 millimeters
Interval 25.49 to 34.64
|
|
Change at Jaw Movements
Opening - Day 28
|
35.27 millimeters
Interval 29.53 to 35.92
|
34.00 millimeters
Interval 30.85 to 37.47
|
31.50 millimeters
Interval 29.27 to 33.9
|
|
Change at Jaw Movements
Opening - Day 90
|
36.86 millimeters
Interval 34.51 to 39.36
|
33.38 millimeters
Interval 30.78 to 36.21
|
31.93 millimeters
Interval 30.41 to 33.52
|
|
Change at Jaw Movements
Maximum opening - day 0
|
40.86 millimeters
Interval 37.62 to 44.09
|
38.46 millimeters
Interval 35.06 to 41.86
|
35.29 millimeters
Interval 31.02 to 39.54
|
|
Change at Jaw Movements
Maximum opening - day 28
|
42.79 millimeters
Interval 40.15 to 45.42
|
41.85 millimeters
Interval 39.6 to 44.09
|
38.93 millimeters
Interval 36.7 to 41.16
|
|
Change at Jaw Movements
Maximum opening - day 90
|
44.50 millimeters
Interval 42.24 to 46.76
|
42.54 millimeters
Interval 39.56 to 45.51
|
39.93 millimeters
Interval 37.86 to 42.0
|
|
Change at Jaw Movements
Right excursion - day 0
|
5.93 millimeters
Interval 4.26 to 8.26
|
6.31 millimeters
Interval 5.13 to 7.76
|
6.57 millimeters
Interval 5.21 to 8.29
|
|
Change at Jaw Movements
Right excursion - day 28
|
8.36 millimeters
Interval 7.21 to 9.68
|
8.62 millimeters
Interval 6.91 to 10.74
|
6.64 millimeters
Interval 5.63 to 7.83
|
|
Change at Jaw Movements
Right excursion - day 90
|
7.90 millimeters
Interval 6.69 to 9.33
|
8.31 millimeters
Interval 7.06 to 9.78
|
7.36 millimeters
Interval 6.57 to 8.24
|
SECONDARY outcome
Timeframe: 0,90 daysRDC/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.
Outcome measures
| Measure |
Photobiomodulation Group
n=14 Participants
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.
|
Manual Therapy Group (MT)
n=13 Participants
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.
|
Combined Therapy Group (CT)
n=14 Participants
Applied the protocols of photobiomodulation group and immediately after, to MT group.
|
|---|---|---|---|
|
Change on Chronic Pain Grades
Day 0 · Low Incapacity
|
10 Participants
|
12 Participants
|
7 Participants
|
|
Change on Chronic Pain Grades
Day 0 · High Incapacity
|
4 Participants
|
1 Participants
|
7 Participants
|
|
Change on Chronic Pain Grades
Day 90 · Low Incapacity
|
13 Participants
|
13 Participants
|
8 Participants
|
|
Change on Chronic Pain Grades
Day 90 · High Incapacity
|
1 Participants
|
0 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 0,90 daysRDC/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).
Outcome measures
| Measure |
Photobiomodulation Group
n=14 Participants
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.
|
Manual Therapy Group (MT)
n=13 Participants
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.
|
Combined Therapy Group (CT)
n=14 Participants
Applied the protocols of photobiomodulation group and immediately after, to MT group.
|
|---|---|---|---|
|
Changes on Levels of Depression Symptoms
Day 0 · No depression
|
6 Participants
|
7 Participants
|
3 Participants
|
|
Changes on Levels of Depression Symptoms
Day 0 · Moderate/Severe depression
|
8 Participants
|
6 Participants
|
11 Participants
|
|
Changes on Levels of Depression Symptoms
Day 90 · No depression
|
11 Participants
|
9 Participants
|
9 Participants
|
|
Changes on Levels of Depression Symptoms
Day 90 · Moderate/Severe depression
|
3 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 0, 90 daysRDC/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.
Outcome measures
| Measure |
Photobiomodulation Group
n=14 Participants
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.
|
Manual Therapy Group (MT)
n=13 Participants
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.
|
Combined Therapy Group (CT)
n=14 Participants
Applied the protocols of photobiomodulation group and immediately after, to MT group.
|
|---|---|---|---|
|
Change on Nonspecific Physical Symptoms With Pain
Day 0 · Normal
|
3 Participants
|
5 Participants
|
2 Participants
|
|
Change on Nonspecific Physical Symptoms With Pain
Day 0 · Moderate/Severe symptoms
|
11 Participants
|
8 Participants
|
12 Participants
|
|
Change on Nonspecific Physical Symptoms With Pain
Day 90 · Normal
|
7 Participants
|
10 Participants
|
6 Participants
|
|
Change on Nonspecific Physical Symptoms With Pain
Day 90 · Moderate/Severe symptoms
|
7 Participants
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 0, 90 daysRDC/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.
Outcome measures
| Measure |
Photobiomodulation Group
n=14 Participants
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.
|
Manual Therapy Group (MT)
n=13 Participants
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.
|
Combined Therapy Group (CT)
n=14 Participants
Applied the protocols of photobiomodulation group and immediately after, to MT group.
|
|---|---|---|---|
|
Change on Nonspecific Physical Symptoms Without Pain
Day 0 · Normal
|
5 Participants
|
6 Participants
|
2 Participants
|
|
Change on Nonspecific Physical Symptoms Without Pain
Day 0 · Moderate/Severe symptoms
|
9 Participants
|
7 Participants
|
12 Participants
|
|
Change on Nonspecific Physical Symptoms Without Pain
Day 90 · Normal
|
8 Participants
|
11 Participants
|
8 Participants
|
|
Change on Nonspecific Physical Symptoms Without Pain
Day 90 · Moderate/Severe symptoms
|
6 Participants
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 0, 90 daysPopulation: To the Analysis of Population, we used the mean and the confidence interval of scores of all participants from each group.
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.
Outcome measures
| Measure |
Photobiomodulation Group
n=14 Participants
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.
|
Manual Therapy Group (MT)
n=13 Participants
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.
|
Combined Therapy Group (CT)
n=14 Participants
Applied the protocols of photobiomodulation group and immediately after, to MT group.
|
|---|---|---|---|
|
Changes on Mandibular Function
Eating soft foods - day 0
|
0.07 score on a scale
Interval 0.01 to 0.37
|
0.23 score on a scale
Interval 0.08 to 0.52
|
0.36 score on a scale
Interval 0.16 to 0.62
|
|
Changes on Mandibular Function
Eating soft foods - day 90
|
0.00 score on a scale
Interval 0.0 to 0.0
|
0.00 score on a scale
Interval 0.0 to 0.0
|
0.14 score on a scale
Interval 0.04 to 0.43
|
|
Changes on Mandibular Function
Smiling - day 0
|
0.36 score on a scale
Interval 0.16 to 0.62
|
0.31 score on a scale
Interval 0.12 to 0.59
|
0.50 score on a scale
Interval 0.26 to 0.74
|
|
Changes on Mandibular Function
Smiling - day 90
|
0.07 score on a scale
Interval 0.01 to 0.37
|
0.08 score on a scale
Interval 0.01 to 0.39
|
0.36 score on a scale
Interval 0.16 to 0.62
|
|
Changes on Mandibular Function
Swallowing - day 0
|
0.14 score on a scale
Interval 0.04 to 0.43
|
0.23 score on a scale
Interval 0.08 to 0.52
|
0.43 score on a scale
Interval 0.21 to 0.68
|
|
Changes on Mandibular Function
Swallowing - day 90
|
0.07 score on a scale
Interval 0.01 to 0.37
|
0.00 score on a scale
Interval 0.0 to 0.0
|
0.21 score on a scale
Interval 0.07 to 0.49
|
|
Changes on Mandibular Function
Chewing - day 0
|
0.5 score on a scale
Interval 0.26 to 0.74
|
0.85 score on a scale
Interval 0.55 to 0.96
|
0.93 score on a scale
Interval 0.63 to 0.99
|
|
Changes on Mandibular Function
Chewing - day 90
|
0.29 score on a scale
Interval 0.11 to 0.56
|
0.38 score on a scale
Interval 0.17 to 0.66
|
0.57 score on a scale
Interval 0.32 to 0.79
|
|
Changes on Mandibular Function
Exercising - day 0
|
0.07 score on a scale
Interval 0.01 to 0.37
|
0.08 score on a scale
Interval 0.01 to 0.39
|
0.50 score on a scale
Interval 0.26 to 0.74
|
|
Changes on Mandibular Function
Exercising - day 90
|
0.00 score on a scale
Interval 0.0 to 0.0
|
0.08 score on a scale
Interval 0.01 to 0.39
|
0.07 score on a scale
Interval 0.01 to 0.37
|
|
Changes on Mandibular Function
Eating hard foods - day 0
|
0.71 score on a scale
Interval 0.44 to 0.89
|
0.85 score on a scale
Interval 0.55 to 0.96
|
0.36 score on a scale
Interval 0.16 to 0.62
|
|
Changes on Mandibular Function
Eating hard foods - day 90
|
0.43 score on a scale
Interval 0.21 to 0.68
|
0.54 score on a scale
Interval 0.28 to 0.78
|
0.71 score on a scale
Interval 0.44 to 0.89
|
SECONDARY outcome
Timeframe: 0,90 daysBeck 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.
Outcome measures
| Measure |
Photobiomodulation Group
n=14 Participants
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.
|
Manual Therapy Group (MT)
n=13 Participants
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.
|
Combined Therapy Group (CT)
n=14 Participants
Applied the protocols of photobiomodulation group and immediately after, to MT group.
|
|---|---|---|---|
|
Changes on Levels of Anxiety
Day 0
|
17.86 score on a scale
Interval 8.56 to 27.15
|
14.92 score on a scale
Interval 6.31 to 23.54
|
31.21 score on a scale
Interval 21.93 to 40.49
|
|
Changes on Levels of Anxiety
Day 90
|
9.57 score on a scale
Interval 2.01 to 17.14
|
7.92 score on a scale
Interval 3.93 to 11.91
|
13.57 score on a scale
Interval 8.54 to 18.6
|
Adverse Events
Photobiomodulation Group (PBM)
Manual Therapy Group (MT)
Combined Therapy Group (CT)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
PhD Manoela Domingues Martins
Federal University of Rio Grande do Sul
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place