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Efficacy Of Different Types Of Physiotherapy Approaches In Temporomandibular Disorders

Primary Purpose

Temporomandibular Disorder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Low Level Laser Therapy
Manuel Pressure Release
Patient Education
Sponsored by
Bitlis Eren University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorder focused on measuring Temporomandibular disorders, Exercise, Low-level laser therapy

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cases who have 3 or more symptoms related to TMJ problems
  • cases who have trigger points in cervical and masticatory muscles
  • cases who TMD detected by the dentist,
  • being between the ages of 18-30,
  • volunteer to participate in the study

Exclusion Criteria:

  • Patients with a positive history of trauma in the face and neck area and neurological disorders
  • patients undergoing TMJ or cervical region surgery in the last 3 months,
  • patients who used dental orthotics within 1 month,
  • patients who have TMJ instability,
  • patients who have cervical and upper thoracic region,
  • patients who have active infection and chronic pain, such as trigeminal neuralgia

Sites / Locations

  • Marmara University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Exercise Program

Low Level Laser Therapy Program

Manual Pressure Release Program

Arm Description

This group received therapeutic exercises and patient education. For patients to encounter fewer problems and to reduce their problems, some recommendations were made that should be taken into consideration in daily life. These suggestions were given in writing. The exercise program included muscle stretching, massage of painful muscles, guided opening and closing movements, gentle isometric tension exercises against resistance, correction of body posture and relaxation techniques. All exercises were done in 6 repetitions a set, 3 sets a day, 3 days a week, treatment program lasted 4 weeks.

This group received LLLT, therapeutic exercises and patient education in the therapy programs. LLLT (max output power: 1200mW, wavelength: 808 nm, dosage: 10j/ cm2 Electronica Pagani Laser Tower Light, Italy) 2.5-4j/TrP dosage was applied to MTrP or sensitive points. The application was applied to MTrP or sensitive points in the mastication and cervical muscles.LLLT program was done in 3 days a week, the treatment program lasted 4 weeks.

ThisThis group received manual pressure release (MPR), therapeutic exercises and patient education in the therapy programs. MPR technique is a noninvasive method based on pressure on the trigger point in accordance with the patient's tolerance and technique applies supine position relax as much as possible, MTrPs in the mastication and neck muscle. Applied pressure gradually with finger over the MTrPs until the subject reported a 'moderate but easily tolerable' pain value of 7 out of 10. When the pain value decreased to at least 3 or 4 therapist increased pressure again until discomfort and/or pain appeared again. This process was repeated until there was no MTrP tension/tenderness or 60 s had elapsed. MPR program was done in 3 days a week, the treatment program lasted 4 weeks.

Outcomes

Primary Outcome Measures

Pressure Pain Threshold Assessment
Pressure Pain Threshold (PPT) of an individual's mastication and cervical muscle was measured with an algometer (JTECH Medical Industries, CommanderTMAlgometer), and the applied pressure was increased to 1 cm2/ kg per second. PPT measurements were repeated three times and the average was used for analysis in every participant.
Pain Severity Assessment
To evaluate the general pain severity of the patients, the Visual Analog Scale (VAS), which is the Visual Pain Scale of Turkish, was used. Patients were asked to mark their general pain separately on a 10 cm scale. According to this, "0" indicates that there is no pain, and "10" indicates the most severe pain. The distance between the marked point and the beginning of the line was recorded in centimeters
Jaw Movements Assessment
Maximum mouth opening (MMO) and lateral deviation were measured with a caliper.
Neck Movements Assessment
Cervical rotations and the craniovertebral angle between C7 and tragus were measured by a goniometer.
Temporomandibular Disorder Severity
The TMD severity in participation is defined by the Craniomandibular Index (CMI) which was developed to provide a standardized measure to the severity of problems in mandibular movement, muscle, and joint tenderness and TMJ noise for use in epidemiological and clinical outcome studies. The instrument was designed to have clearly defined objective criteria, simple clinical methods, and ease in scoring; it is divided into the Palpation Index (PI) and the Dysfunction Index (DI). The means of the subscales were averaged to produce a CMI score ranging from 0 (best) to 1 (worst)
Quality of Life Assesment
Short Form-36 questionnaire contains the physical and mental component, which is evaluated, is close to 100, indicating an increase in health-related quality of life. The means SF-36 score ranging from 0 (worst) to 100 (best).

Secondary Outcome Measures

Neck Disability Assesment
Northwick Park Neck Pain Questionnaire; Neck pain severity, neck pain and sleep, numbness and tingling in the arms at night, duration of symptoms and complaints, weight-bearing, reading and watching television, work and housework, social activities and driving includes 9 items. Each item consists of 5 options, the level of disability increases as you approach 36 points. The means northwick park neck pain questionnaire score ranging from 0 (best) to 36 (worst).
Psychological Status Assesment
Beck depression index which is a two-factor scale, emotion and somatic, has 21 questions, the lowest score is 0 and the highest score is 3 in each question. The means Beck depression index score ranging from 0 (best) to 63 (worst).

Full Information

First Posted
February 29, 2020
Last Updated
March 2, 2020
Sponsor
Bitlis Eren University
Collaborators
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT04294602
Brief Title
Efficacy Of Different Types Of Physiotherapy Approaches In Temporomandibular Disorders
Official Title
Efficacy Of Different Types Of Physiotherapy Approaches In Temporomandibular Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
March 13, 2018 (Actual)
Study Completion Date
May 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bitlis Eren University
Collaborators
Marmara University

4. Oversight

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

5. Study Description

Brief Summary
The aim of this study is to investigate the efficacy of different types of physiotherapy approaches in cases with cervical myofascial painful TMD.
Detailed Description
59 persons with TMD diagnosed by the dentist and with cervical myofascial pain, aged 18-30 years will be randomly allocated, 3 groups. The participants were randomly allocated only exercise group (EG) (n=20), low-level laser therapy plus exercise group (LLLT) (n=17) and manual pressure release plus exercise group (MPR) (n=22). The cases were evaluated and treated by the same physiotherapist for 4 weeks (12 sessions). Pain, pain pressure threshold, temporomandibular joint (TMJ) mobility and disability, forward head posture, head rotation, neck disability, psychological status and quality of life were evaluated. Evaluations were repeated before and after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder
Keywords
Temporomandibular disorders, Exercise, Low-level laser therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Program
Arm Type
Experimental
Arm Description
This group received therapeutic exercises and patient education. For patients to encounter fewer problems and to reduce their problems, some recommendations were made that should be taken into consideration in daily life. These suggestions were given in writing. The exercise program included muscle stretching, massage of painful muscles, guided opening and closing movements, gentle isometric tension exercises against resistance, correction of body posture and relaxation techniques. All exercises were done in 6 repetitions a set, 3 sets a day, 3 days a week, treatment program lasted 4 weeks.
Arm Title
Low Level Laser Therapy Program
Arm Type
Experimental
Arm Description
This group received LLLT, therapeutic exercises and patient education in the therapy programs. LLLT (max output power: 1200mW, wavelength: 808 nm, dosage: 10j/ cm2 Electronica Pagani Laser Tower Light, Italy) 2.5-4j/TrP dosage was applied to MTrP or sensitive points. The application was applied to MTrP or sensitive points in the mastication and cervical muscles.LLLT program was done in 3 days a week, the treatment program lasted 4 weeks.
Arm Title
Manual Pressure Release Program
Arm Type
Experimental
Arm Description
ThisThis group received manual pressure release (MPR), therapeutic exercises and patient education in the therapy programs. MPR technique is a noninvasive method based on pressure on the trigger point in accordance with the patient's tolerance and technique applies supine position relax as much as possible, MTrPs in the mastication and neck muscle. Applied pressure gradually with finger over the MTrPs until the subject reported a 'moderate but easily tolerable' pain value of 7 out of 10. When the pain value decreased to at least 3 or 4 therapist increased pressure again until discomfort and/or pain appeared again. This process was repeated until there was no MTrP tension/tenderness or 60 s had elapsed. MPR program was done in 3 days a week, the treatment program lasted 4 weeks.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Exercise therapy intended in reducing muscle spasm, improving coordination of the mastication muscles and alter the jaw closure pattern.
Intervention Type
Other
Intervention Name(s)
Low Level Laser Therapy
Intervention Description
LLLT (max output power: 1200mW, wavelength: 808 nm, dosage: 10j/ cm2 Electronica Pagani Laser Tower Light, Italy) 2.5-4j/TrP dosage was applied to MTrP or sensitive points.
Intervention Type
Other
Intervention Name(s)
Manuel Pressure Release
Intervention Description
MPR technique is a noninvasive method based on pressure on the trigger point in accordance with the patient's tolerance and technique applies supine position relax as much as possible, manuel pressure applied trigger point in neck and mactication muscles
Intervention Type
Other
Intervention Name(s)
Patient Education
Intervention Description
Some suggestions were made to TMD people who should pay attention to in daily life. These suggestions were given in writing.
Primary Outcome Measure Information:
Title
Pressure Pain Threshold Assessment
Description
Pressure Pain Threshold (PPT) of an individual's mastication and cervical muscle was measured with an algometer (JTECH Medical Industries, CommanderTMAlgometer), and the applied pressure was increased to 1 cm2/ kg per second. PPT measurements were repeated three times and the average was used for analysis in every participant.
Time Frame
Change from baseline pressure pain threshold score in neck and mastication muscles at week 4.
Title
Pain Severity Assessment
Description
To evaluate the general pain severity of the patients, the Visual Analog Scale (VAS), which is the Visual Pain Scale of Turkish, was used. Patients were asked to mark their general pain separately on a 10 cm scale. According to this, "0" indicates that there is no pain, and "10" indicates the most severe pain. The distance between the marked point and the beginning of the line was recorded in centimeters
Time Frame
Change from baseline TMJ pain and intensity of head pain, TMJ noise and jaw locking score at week 4.
Title
Jaw Movements Assessment
Description
Maximum mouth opening (MMO) and lateral deviation were measured with a caliper.
Time Frame
Change from baseline MMO and lateral deviation score at week 4.
Title
Neck Movements Assessment
Description
Cervical rotations and the craniovertebral angle between C7 and tragus were measured by a goniometer.
Time Frame
Change from baseline cervical rotations and craniovertebral angle score at week 4.
Title
Temporomandibular Disorder Severity
Description
The TMD severity in participation is defined by the Craniomandibular Index (CMI) which was developed to provide a standardized measure to the severity of problems in mandibular movement, muscle, and joint tenderness and TMJ noise for use in epidemiological and clinical outcome studies. The instrument was designed to have clearly defined objective criteria, simple clinical methods, and ease in scoring; it is divided into the Palpation Index (PI) and the Dysfunction Index (DI). The means of the subscales were averaged to produce a CMI score ranging from 0 (best) to 1 (worst)
Time Frame
Change from baseline temporomandibular disorder severity score at week 4
Title
Quality of Life Assesment
Description
Short Form-36 questionnaire contains the physical and mental component, which is evaluated, is close to 100, indicating an increase in health-related quality of life. The means SF-36 score ranging from 0 (worst) to 100 (best).
Time Frame
Change from baseline quality of life score at week 4
Secondary Outcome Measure Information:
Title
Neck Disability Assesment
Description
Northwick Park Neck Pain Questionnaire; Neck pain severity, neck pain and sleep, numbness and tingling in the arms at night, duration of symptoms and complaints, weight-bearing, reading and watching television, work and housework, social activities and driving includes 9 items. Each item consists of 5 options, the level of disability increases as you approach 36 points. The means northwick park neck pain questionnaire score ranging from 0 (best) to 36 (worst).
Time Frame
Change from baseline neck disability score at week 4.
Title
Psychological Status Assesment
Description
Beck depression index which is a two-factor scale, emotion and somatic, has 21 questions, the lowest score is 0 and the highest score is 3 in each question. The means Beck depression index score ranging from 0 (best) to 63 (worst).
Time Frame
Change from baseline psychological status score at week 4.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cases who have 3 or more symptoms related to TMJ problems cases who have trigger points in cervical and masticatory muscles cases who TMD detected by the dentist, being between the ages of 18-30, volunteer to participate in the study Exclusion Criteria: Patients with a positive history of trauma in the face and neck area and neurological disorders patients undergoing TMJ or cervical region surgery in the last 3 months, patients who used dental orthotics within 1 month, patients who have TMJ instability, patients who have cervical and upper thoracic region, patients who have active infection and chronic pain, such as trigeminal neuralgia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdurrahman TANHAN, MSc
Organizational Affiliation
Bitlis Eren University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara University
City
Istanbul
State/Province
Maltepe
ZIP/Postal Code
34000
Country
Turkey

12. IPD Sharing Statement

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Efficacy Of Different Types Of Physiotherapy Approaches In Temporomandibular Disorders

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