Temporomandibular Disorder Clinical Trial
Official title:
Efficacy Of Different Types Of Physiotherapy Approaches In Temporomandibular Disorders
NCT number | NCT04294602 |
Other study ID # | BitlisErenU1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 15, 2017 |
Est. completion date | May 10, 2018 |
Verified date | March 2020 |
Source | Bitlis Eren University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to investigate the efficacy of different types of physiotherapy approaches in cases with cervical myofascial painful TMD.
Status | Completed |
Enrollment | 59 |
Est. completion date | May 10, 2018 |
Est. primary completion date | March 13, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Marmara University | Istanbul | Maltepe |
Lead Sponsor | Collaborator |
---|---|
Bitlis Eren University | Marmara University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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 | |
Primary | 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 | 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). | Change from baseline neck disability score at week 4. | |
Secondary | 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). | Change from baseline psychological status score at week 4. |
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