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CompletedNCT04294602Updated Mar 4, 2020

Efficacy Of Different Types Of Physiotherapy Approaches In Temporomandibular Disorders

An interventional study of Exercise and Low Level Laser Therapy in Temporomandibular Disorder, sponsored by Bitlis Eren University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2020-03-04.

Sponsored by Bitlis Eren University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled May 2017, registered Feb 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study summary

The aim of this study is to investigate the efficacy of different types of physiotherapy approaches in cases with cervical myofascial painful TMD.

Read the 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.

02

Conditions studied

  • Temporomandibular Disorder

Keywords

  • Temporomandibular disorders
  • Exercise
  • Low-level laser therapy
03

In context

Temporomandibular Joint Disorders

609 studies on the registry are indexed under Temporomandibular Joint Disorders; 160 are open to participants now.

This study's enrollment of 59 is above the median of 46 across 434 interventional studies indexed under Temporomandibular Joint Disorders.

Browse Temporomandibular Joint Disorders studies →

Lead sponsor

Bitlis Eren University is the lead sponsor of 48 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    Exercise Program

    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: Exercise · Other: Patient Education

  • Experimental
    Low Level Laser Therapy Program

    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: Exercise · Other: Low Level Laser Therapy · Other: Patient Education

  • Experimental
    Manual Pressure Release Program

    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: Exercise · Other: Manuel Pressure Release · Other: Patient Education

Interventions

  • OtherExercise

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

  • OtherLow Level Laser Therapy

    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.

  • OtherManuel Pressure Release

    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

  • OtherPatient Education

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

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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

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

  3. Jaw Movements Assessment

    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.

  4. Neck Movements Assessment

    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.

  5. 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)

    Time frame: Change from baseline temporomandibular disorder severity score at week 4

  6. 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).

    Time frame: Change from baseline quality of life score at week 4

Secondary outcomes

  1. 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).

    Time frame: Change from baseline neck disability score at week 4.

  2. 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).

    Time frame: Change from baseline psychological status score at week 4.

07

Study locations

1 site
  • Marmara University
    Istanbul, Maltepe 34000, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04294602
Lead sponsor
Bitlis Eren University
Collaborators
Marmara University
Responsible party
Abdurrahman Tanhan (research assistant, Bitlis Eren University) — Principal investigator
First posted
Mar 4, 2020
Start date
May 15, 2017
Primary completion
Mar 13, 2018
Completion
May 10, 2018
Last update
Mar 4, 2020

Study contacts

Abdurrahman TANHAN, MSc
principal investigator · Bitlis Eren University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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