NCT04294602

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 29, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

10 months

First QC Date

February 29, 2020

Last Update Submit

March 2, 2020

Conditions

Keywords

Temporomandibular disordersExerciseLow-level laser therapy

Outcome Measures

Primary Outcomes (6)

  • 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.

    Change from baseline pressure pain threshold score in neck and mastication muscles at week 4.

  • 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

    Change from baseline TMJ pain and intensity of head pain, TMJ noise and jaw locking score at week 4.

  • Jaw Movements Assessment

    Maximum mouth opening (MMO) and lateral deviation were measured with a caliper.

    Change from baseline MMO and lateral deviation score at week 4.

  • Neck Movements Assessment

    Cervical rotations and the craniovertebral angle between C7 and tragus were measured by a goniometer.

    Change from baseline cervical rotations and craniovertebral angle score at week 4.

  • 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)

    Change from baseline temporomandibular disorder severity score at week 4

  • 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).

    Change from baseline quality of life score at week 4

Secondary Outcomes (2)

  • Neck Disability Assesment

    Change from baseline neck disability score at week 4.

  • Psychological Status Assesment

    Change from baseline psychological status score at week 4.

Study Arms (3)

Exercise Program

EXPERIMENTAL

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.

Other: ExerciseOther: Patient Education

Low Level Laser Therapy Program

EXPERIMENTAL

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.

Other: ExerciseOther: Low Level Laser TherapyOther: Patient Education

Manual Pressure Release Program

EXPERIMENTAL

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.

Other: ExerciseOther: Manuel Pressure ReleaseOther: Patient Education

Interventions

Exercise therapy intended in reducing muscle spasm, improving coordination of the mastication muscles and alter the jaw closure pattern.

Exercise ProgramLow Level Laser Therapy ProgramManual Pressure Release Program

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.

Low Level Laser Therapy Program

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

Manual Pressure Release Program

Some suggestions were made to TMD people who should pay attention to in daily life. These suggestions were given in writing.

Exercise ProgramLow Level Laser Therapy ProgramManual Pressure Release Program

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, Maltepe, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint DisordersMotor Activity

Interventions

ExerciseLow-Level Light TherapyPatient Education as Topic

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaLaser TherapyTherapeuticsPhototherapyHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Abdurrahman TANHAN, MSc

    Bitlis Eren University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

February 29, 2020

First Posted

March 4, 2020

Study Start

May 15, 2017

Primary Completion

March 13, 2018

Study Completion

May 10, 2018

Last Updated

March 4, 2020

Record last verified: 2020-03

Locations