Temporomandibular Disorder
Conditions
Keywords
Temporomandibular Diseases, Photobiomodulation, Low level laser, Treatment, Manual Therapy
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.
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.
Interventions
PROCEDUREPhotobiomodulation
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.
PROCEDUREManual 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 .
Sponsors
Federal University of Rio Grande do Sul
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| Photobiomodulation Group (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. | 18 |
| Manual Therapy Group (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 . | 16 |
| Combined Therapy Group (CT) Applied the protocols of PBM group and immediately after, to MT group.
. | 17 |
| Total | 51 |
Baseline characteristics
| Characteristic | Photobiomodulation Group (PBM) | Manual Therapy Group (MT) | Combined Therapy Group (CT) | Total |
|---|---|---|---|---|
| Age, Continuous | 46.29 years STANDARD_DEVIATION 14.43 | 42.44 years STANDARD_DEVIATION 17.45 | 41.65 years STANDARD_DEVIATION 19.46 | 43.48 years STANDARD_DEVIATION 17.01 |
| Duration of pain | 8.8 years STANDARD_DEVIATION 6.9 | 10.1 years STANDARD_DEVIATION 12.8 | 9.2 years STANDARD_DEVIATION 9 | 9.4 years STANDARD_DEVIATION 9.9 |
| Sex: Female, Male Female | 18 Participants | 15 Participants | 16 Participants | 49 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 13 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 | 0 / 14 |
Outcome results
Primary
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.
Time frame: 0,7,14,21,28,60,90 days
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Photobiomodulation Group | Change From Baseline in Visual Analogic Scale (VAS) for Pain | Day 7 | 3.3 millimeters |
| Photobiomodulation Group | Change From Baseline in Visual Analogic Scale (VAS) for Pain | Day 28 | 1.1 millimeters |
| Photobiomodulation Group | Change From Baseline in Visual Analogic Scale (VAS) for Pain | Day 21 | 1.8 millimeters |
| Photobiomodulation Group | Change From Baseline in Visual Analogic Scale (VAS) for Pain | Baseline | 4.1 millimeters |
| Photobiomodulation Group | Change From Baseline in Visual Analogic Scale (VAS) for Pain | Day 90 | 1.6 millimeters |
| Photobiomodulation Group | Change From Baseline in Visual Analogic Scale (VAS) for Pain | Day 60 | 0.8 millimeters |
| Photobiomodulation Group | Change From Baseline in Visual Analogic Scale (VAS) for Pain | Day14 | 1.9 millimeters |
| Manual Therapy Group (MT) | Change From Baseline in Visual Analogic Scale (VAS) for Pain | Day 21 | 0.5 millimeters |
| Manual Therapy Group (MT) | Change From Baseline in Visual Analogic Scale (VAS) for Pain | Baseline | 4.4 millimeters |
| Manual Therapy Group (MT) | Change From Baseline in Visual Analogic Scale (VAS) for Pain | Day 7 | 2.8 millimeters |
| Manual Therapy Group (MT) | Change From Baseline in Visual Analogic Scale (VAS) for Pain | Day14 | 1.7 millimeters |
| Manual Therapy Group (MT) | Change From Baseline in Visual Analogic Scale (VAS) for Pain | Day 28 | 1.3 millimeters |
| Manual Therapy Group (MT) | Change From Baseline in Visual Analogic Scale (VAS) for Pain | Day 60 | 0.6 millimeters |
| Manual Therapy Group (MT) | Change From Baseline in Visual Analogic Scale (VAS) for Pain | Day 90 | 0.9 millimeters |
| Combined Therapy Group (CT) | Change From Baseline in Visual Analogic Scale (VAS) for Pain | Day 28 | 0.9 millimeters |
| Combined Therapy Group (CT) | Change From Baseline in Visual Analogic Scale (VAS) for Pain | Day 7 | 3.4 millimeters |
| Combined Therapy Group (CT) | Change From Baseline in Visual Analogic Scale (VAS) for Pain | Day 90 | 1.9 millimeters |
| Combined Therapy Group (CT) | Change From Baseline in Visual Analogic Scale (VAS) for Pain | Day 60 | 1.2 millimeters |
| Combined Therapy Group (CT) | Change From Baseline in Visual Analogic Scale (VAS) for Pain | Day 21 | 1.9 millimeters |
| Combined Therapy Group (CT) | Change From Baseline in Visual Analogic Scale (VAS) for Pain | Day14 | 2.4 millimeters |
| Combined Therapy Group (CT) | Change From Baseline in Visual Analogic Scale (VAS) for Pain | Baseline | 5.2 millimeters |
p-value: <0.001Regression, Linear
Secondary
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).
Time frame: 0,28,90 days
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Photobiomodulation Group | Change at Jaw Movements | Right excursion - day 0 | 5.93 millimeters |
| Photobiomodulation Group | Change at Jaw Movements | Maximum opening - day 0 | 40.86 millimeters |
| Photobiomodulation Group | Change at Jaw Movements | Right excursion - day 90 | 7.90 millimeters |
| Photobiomodulation Group | Change at Jaw Movements | Maximum opening - day 90 | 44.50 millimeters |
| Photobiomodulation Group | Change at Jaw Movements | Maximum opening - day 28 | 42.79 millimeters |
| Photobiomodulation Group | Change at Jaw Movements | Opening - Day 28 | 35.27 millimeters |
| Photobiomodulation Group | Change at Jaw Movements | Opening - Day 0 | 29.64 millimeters |
| Photobiomodulation Group | Change at Jaw Movements | Right excursion - day 28 | 8.36 millimeters |
| Photobiomodulation Group | Change at Jaw Movements | Opening - Day 90 | 36.86 millimeters |
| Manual Therapy Group (MT) | Change at Jaw Movements | Right excursion - day 28 | 8.62 millimeters |
| Manual Therapy Group (MT) | Change at Jaw Movements | Opening - Day 0 | 27.92 millimeters |
| Manual Therapy Group (MT) | Change at Jaw Movements | Opening - Day 28 | 34.00 millimeters |
| Manual Therapy Group (MT) | Change at Jaw Movements | Opening - Day 90 | 33.38 millimeters |
| Manual Therapy Group (MT) | Change at Jaw Movements | Maximum opening - day 0 | 38.46 millimeters |
| Manual Therapy Group (MT) | Change at Jaw Movements | Maximum opening - day 28 | 41.85 millimeters |
| Manual Therapy Group (MT) | Change at Jaw Movements | Maximum opening - day 90 | 42.54 millimeters |
| Manual Therapy Group (MT) | Change at Jaw Movements | Right excursion - day 0 | 6.31 millimeters |
| Manual Therapy Group (MT) | Change at Jaw Movements | Right excursion - day 90 | 8.31 millimeters |
| Combined Therapy Group (CT) | Change at Jaw Movements | Maximum opening - day 90 | 39.93 millimeters |
| Combined Therapy Group (CT) | Change at Jaw Movements | Opening - Day 90 | 31.93 millimeters |
| Combined Therapy Group (CT) | Change at Jaw Movements | Right excursion - day 90 | 7.36 millimeters |
| Combined Therapy Group (CT) | Change at Jaw Movements | Right excursion - day 0 | 6.57 millimeters |
| Combined Therapy Group (CT) | Change at Jaw Movements | Opening - Day 28 | 31.50 millimeters |
| Combined Therapy Group (CT) | Change at Jaw Movements | Right excursion - day 28 | 6.64 millimeters |
| Combined Therapy Group (CT) | Change at Jaw Movements | Maximum opening - day 28 | 38.93 millimeters |
| Combined Therapy Group (CT) | Change at Jaw Movements | Maximum opening - day 0 | 35.29 millimeters |
| Combined Therapy Group (CT) | Change at Jaw Movements | Opening - Day 0 | 29.71 millimeters |
p-value: 0.05Generalized Estimating Equation
Secondary
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.
Time frame: 0,90 days
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Photobiomodulation Group | Change on Chronic Pain Grades | Day 0 | Low Incapacity | 10 Participants |
| Photobiomodulation Group | Change on Chronic Pain Grades | Day 0 | High Incapacity | 4 Participants |
| Photobiomodulation Group | Change on Chronic Pain Grades | Day 90 | Low Incapacity | 13 Participants |
| Photobiomodulation Group | Change on Chronic Pain Grades | Day 90 | High Incapacity | 1 Participants |
| Manual Therapy Group (MT) | Change on Chronic Pain Grades | Day 90 | High Incapacity | 0 Participants |
| Manual Therapy Group (MT) | Change on Chronic Pain Grades | Day 0 | Low Incapacity | 12 Participants |
| Manual Therapy Group (MT) | Change on Chronic Pain Grades | Day 90 | Low Incapacity | 13 Participants |
| Manual Therapy Group (MT) | Change on Chronic Pain Grades | Day 0 | High Incapacity | 1 Participants |
| Combined Therapy Group (CT) | Change on Chronic Pain Grades | Day 90 | High Incapacity | 6 Participants |
| Combined Therapy Group (CT) | Change on Chronic Pain Grades | Day 0 | High Incapacity | 7 Participants |
| Combined Therapy Group (CT) | Change on Chronic Pain Grades | Day 90 | Low Incapacity | 8 Participants |
| Combined Therapy Group (CT) | Change on Chronic Pain Grades | Day 0 | Low Incapacity | 7 Participants |
p-value: 0.05Generalized Estimating Equation
Secondary
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.
Time frame: 0, 90 days
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Photobiomodulation Group | Change on Nonspecific Physical Symptoms Without Pain | Day 0 | Normal | 5 Participants |
| Photobiomodulation Group | Change on Nonspecific Physical Symptoms Without Pain | Day 0 | Moderate/Severe symptoms | 9 Participants |
| Photobiomodulation Group | Change on Nonspecific Physical Symptoms Without Pain | Day 90 | Normal | 8 Participants |
| Photobiomodulation Group | Change on Nonspecific Physical Symptoms Without Pain | Day 90 | Moderate/Severe symptoms | 6 Participants |
| Manual Therapy Group (MT) | Change on Nonspecific Physical Symptoms Without Pain | Day 90 | Moderate/Severe symptoms | 2 Participants |
| Manual Therapy Group (MT) | Change on Nonspecific Physical Symptoms Without Pain | Day 0 | Normal | 6 Participants |
| Manual Therapy Group (MT) | Change on Nonspecific Physical Symptoms Without Pain | Day 90 | Normal | 11 Participants |
| Manual Therapy Group (MT) | Change on Nonspecific Physical Symptoms Without Pain | Day 0 | Moderate/Severe symptoms | 7 Participants |
| Combined Therapy Group (CT) | Change on Nonspecific Physical Symptoms Without Pain | Day 90 | Moderate/Severe symptoms | 6 Participants |
| Combined Therapy Group (CT) | Change on Nonspecific Physical Symptoms Without Pain | Day 0 | Moderate/Severe symptoms | 12 Participants |
| Combined Therapy Group (CT) | Change on Nonspecific Physical Symptoms Without Pain | Day 90 | Normal | 8 Participants |
| Combined Therapy Group (CT) | Change on Nonspecific Physical Symptoms Without Pain | Day 0 | Normal | 2 Participants |
p-value: 0.05Generalized Estimating Equation
Secondary
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.
Time frame: 0, 90 days
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Photobiomodulation Group | Change on Nonspecific Physical Symptoms With Pain | Day 90 | Normal | 7 Participants |
| Photobiomodulation Group | Change on Nonspecific Physical Symptoms With Pain | Day 0 | Normal | 3 Participants |
| Photobiomodulation Group | Change on Nonspecific Physical Symptoms With Pain | Day 90 | Moderate/Severe symptoms | 7 Participants |
| Photobiomodulation Group | Change on Nonspecific Physical Symptoms With Pain | Day 0 | Moderate/Severe symptoms | 11 Participants |
| Manual Therapy Group (MT) | Change on Nonspecific Physical Symptoms With Pain | Day 90 | Normal | 10 Participants |
| Manual Therapy Group (MT) | Change on Nonspecific Physical Symptoms With Pain | Day 0 | Moderate/Severe symptoms | 8 Participants |
| Manual Therapy Group (MT) | Change on Nonspecific Physical Symptoms With Pain | Day 0 | Normal | 5 Participants |
| Manual Therapy Group (MT) | Change on Nonspecific Physical Symptoms With Pain | Day 90 | Moderate/Severe symptoms | 3 Participants |
| Combined Therapy Group (CT) | Change on Nonspecific Physical Symptoms With Pain | Day 90 | Moderate/Severe symptoms | 8 Participants |
| Combined Therapy Group (CT) | Change on Nonspecific Physical Symptoms With Pain | Day 0 | Normal | 2 Participants |
| Combined Therapy Group (CT) | Change on Nonspecific Physical Symptoms With Pain | Day 0 | Moderate/Severe symptoms | 12 Participants |
| Combined Therapy Group (CT) | Change on Nonspecific Physical Symptoms With Pain | Day 90 | Normal | 6 Participants |
p-value: <0.01Generalized Estimating Equation
Secondary
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.
Time frame: 0,90 days
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Photobiomodulation Group | Changes on Levels of Anxiety | Day 0 | 17.86 score on a scale |
| Photobiomodulation Group | Changes on Levels of Anxiety | Day 90 | 9.57 score on a scale |
| Manual Therapy Group (MT) | Changes on Levels of Anxiety | Day 0 | 14.92 score on a scale |
| Manual Therapy Group (MT) | Changes on Levels of Anxiety | Day 90 | 7.92 score on a scale |
| Combined Therapy Group (CT) | Changes on Levels of Anxiety | Day 0 | 31.21 score on a scale |
| Combined Therapy Group (CT) | Changes on Levels of Anxiety | Day 90 | 13.57 score on a scale |
p-value: 0.05Generalized Estimating Equation
Secondary
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).
Time frame: 0,90 days
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Photobiomodulation Group | Changes on Levels of Depression Symptoms | Day 0 | No depression | 6 Participants |
| Photobiomodulation Group | Changes on Levels of Depression Symptoms | Day 0 | Moderate/Severe depression | 8 Participants |
| Photobiomodulation Group | Changes on Levels of Depression Symptoms | Day 90 | No depression | 11 Participants |
| Photobiomodulation Group | Changes on Levels of Depression Symptoms | Day 90 | Moderate/Severe depression | 3 Participants |
| Manual Therapy Group (MT) | Changes on Levels of Depression Symptoms | Day 90 | Moderate/Severe depression | 4 Participants |
| Manual Therapy Group (MT) | Changes on Levels of Depression Symptoms | Day 0 | No depression | 7 Participants |
| Manual Therapy Group (MT) | Changes on Levels of Depression Symptoms | Day 90 | No depression | 9 Participants |
| Manual Therapy Group (MT) | Changes on Levels of Depression Symptoms | Day 0 | Moderate/Severe depression | 6 Participants |
| Combined Therapy Group (CT) | Changes on Levels of Depression Symptoms | Day 90 | Moderate/Severe depression | 5 Participants |
| Combined Therapy Group (CT) | Changes on Levels of Depression Symptoms | Day 0 | Moderate/Severe depression | 11 Participants |
| Combined Therapy Group (CT) | Changes on Levels of Depression Symptoms | Day 90 | No depression | 9 Participants |
| Combined Therapy Group (CT) | Changes on Levels of Depression Symptoms | Day 0 | No depression | 3 Participants |
p-value: <0.05Generalized Estimating Equation
Secondary
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.
Time frame: 0, 90 days
Population: To the Analysis of Population, we used the mean and the confidence interval of scores of all participants from each group.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Photobiomodulation Group | Changes on Mandibular Function | Eating hard foods - day 0 | 0.71 score on a scale |
| Photobiomodulation Group | Changes on Mandibular Function | Chewing - day 90 | 0.29 score on a scale |
| Photobiomodulation Group | Changes on Mandibular Function | Swallowing - day 0 | 0.14 score on a scale |
| Photobiomodulation Group | Changes on Mandibular Function | Eating soft foods - day 90 | 0.00 score on a scale |
| Photobiomodulation Group | Changes on Mandibular Function | Chewing - day 0 | 0.5 score on a scale |
| Photobiomodulation Group | Changes on Mandibular Function | Swallowing - day 90 | 0.07 score on a scale |
| Photobiomodulation Group | Changes on Mandibular Function | Eating soft foods - day 0 | 0.07 score on a scale |
| Photobiomodulation Group | Changes on Mandibular Function | Exercising - day 90 | 0.00 score on a scale |
| Photobiomodulation Group | Changes on Mandibular Function | Smiling - day 0 | 0.36 score on a scale |
| Photobiomodulation Group | Changes on Mandibular Function | Eating hard foods - day 90 | 0.43 score on a scale |
| Photobiomodulation Group | Changes on Mandibular Function | Exercising - day 0 | 0.07 score on a scale |
| Photobiomodulation Group | Changes on Mandibular Function | Smiling - day 90 | 0.07 score on a scale |
| Manual Therapy Group (MT) | Changes on Mandibular Function | Swallowing - day 90 | 0.00 score on a scale |
| Manual Therapy Group (MT) | Changes on Mandibular Function | Eating soft foods - day 0 | 0.23 score on a scale |
| Manual Therapy Group (MT) | Changes on Mandibular Function | Eating soft foods - day 90 | 0.00 score on a scale |
| Manual Therapy Group (MT) | Changes on Mandibular Function | Smiling - day 0 | 0.31 score on a scale |
| Manual Therapy Group (MT) | Changes on Mandibular Function | Smiling - day 90 | 0.08 score on a scale |
| Manual Therapy Group (MT) | Changes on Mandibular Function | Swallowing - day 0 | 0.23 score on a scale |
| Manual Therapy Group (MT) | Changes on Mandibular Function | Eating hard foods - day 90 | 0.54 score on a scale |
| Manual Therapy Group (MT) | Changes on Mandibular Function | Chewing - day 0 | 0.85 score on a scale |
| Manual Therapy Group (MT) | Changes on Mandibular Function | Chewing - day 90 | 0.38 score on a scale |
| Manual Therapy Group (MT) | Changes on Mandibular Function | Exercising - day 0 | 0.08 score on a scale |
| Manual Therapy Group (MT) | Changes on Mandibular Function | Exercising - day 90 | 0.08 score on a scale |
| Manual Therapy Group (MT) | Changes on Mandibular Function | Eating hard foods - day 0 | 0.85 score on a scale |
| Combined Therapy Group (CT) | Changes on Mandibular Function | Eating soft foods - day 0 | 0.36 score on a scale |
| Combined Therapy Group (CT) | Changes on Mandibular Function | Chewing - day 90 | 0.57 score on a scale |
| Combined Therapy Group (CT) | Changes on Mandibular Function | Smiling - day 0 | 0.50 score on a scale |
| Combined Therapy Group (CT) | Changes on Mandibular Function | Eating hard foods - day 90 | 0.71 score on a scale |
| Combined Therapy Group (CT) | Changes on Mandibular Function | Exercising - day 0 | 0.50 score on a scale |
| Combined Therapy Group (CT) | Changes on Mandibular Function | Eating soft foods - day 90 | 0.14 score on a scale |
| Combined Therapy Group (CT) | Changes on Mandibular Function | Eating hard foods - day 0 | 0.36 score on a scale |
| Combined Therapy Group (CT) | Changes on Mandibular Function | Swallowing - day 90 | 0.21 score on a scale |
| Combined Therapy Group (CT) | Changes on Mandibular Function | Swallowing - day 0 | 0.43 score on a scale |
| Combined Therapy Group (CT) | Changes on Mandibular Function | Exercising - day 90 | 0.07 score on a scale |
| Combined Therapy Group (CT) | Changes on Mandibular Function | Chewing - day 0 | 0.93 score on a scale |
| Combined Therapy Group (CT) | Changes on Mandibular Function | Smiling - day 90 | 0.36 score on a scale |
p-value: 0.05Generalized Estimating Equation