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Completed

NCT Number: NCT04294602

Efficacy Of Different Types Of Physiotherapy Approaches In Temporomandibular Disorders

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

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Key information

Conditions

Temporomandibular Disorder Behavior Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Motor Activity Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University

Istanbul, Maltepe, 34000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

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

Low Level Laser Therapy

Other

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.

Manuel Pressure Release

Other

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

Patient Education

Other

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

Primary outcomes

  1. Pressure Pain Threshold Assessment

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

    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.

  2. Pain Severity Assessment

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

    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

  3. Jaw Movements Assessment

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

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

  4. Neck Movements Assessment

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

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

  5. Temporomandibular Disorder Severity

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

    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)

  6. Quality of Life Assesment

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

    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 outcomes

  1. Neck Disability Assesment

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

    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).

  2. Psychological Status Assesment

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

    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).

Sponsors and collaborators

Lead sponsor

Bitlis Eren University

Other

Collaborators

  • Marmara University

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 4, 2020
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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