search
Back to results

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

Primary Purpose

Temporomandibular Disorder

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Photobiomodulation
Manual Therapy (MT)
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorder focused on measuring Temporomandibular Diseases, Photobiomodulation, Low level laser, Treatment, Manual Therapy

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Photobiomodulation group (PBM)

    Manual Therapy group (MT)

    Combined therapy group (CT)

    Arm 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 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

    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.

    Applied the protocols of PBM group and immediately after, to MT group. 17 individuals.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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).
    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.
    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).
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    February 5, 2018
    Last Updated
    August 26, 2019
    Sponsor
    Federal University of Rio Grande do Sul
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03454581
    Brief Title
    Effectiveness of Photobiomodulation and Manual Therapy Alone or Combined in TMD Patients
    Acronym
    TMDPBMT
    Official Title
    Comparative Effectiveness of Photobiomodulation and Manual Therapy Alone or Combined in TMD Patients: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    May 17, 2016 (Actual)
    Primary Completion Date
    November 14, 2016 (Actual)
    Study Completion Date
    November 14, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Rio Grande do Sul

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Temporomandibular Disorder
    Keywords
    Temporomandibular Diseases, Photobiomodulation, Low level laser, Treatment, Manual Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    51 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Photobiomodulation group (PBM)
    Arm Type
    Experimental
    Arm 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 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
    Arm Title
    Manual Therapy group (MT)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Combined therapy group (CT)
    Arm Type
    Experimental
    Arm Description
    Applied the protocols of PBM group and immediately after, to MT group. 17 individuals.
    Intervention Type
    Procedure
    Intervention Name(s)
    Photobiomodulation
    Other Intervention Name(s)
    Low Level Laser (PBM)
    Intervention 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Manual Therapy (MT)
    Intervention Description
    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 .
    Primary Outcome Measure Information:
    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
    Secondary Outcome Measure Information:
    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
    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
    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
    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
    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
    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
    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

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs