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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05481268
Other study ID # IstanbulArelUTME
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2018
Est. completion date July 19, 2018

Study information

Verified date July 2022
Source Istanbul Arel University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Purpose: This study determined the effects of Kinesiotaping and Stretching on pain, cervical joint range of motion and functional status in patients with myofascial pain due to temporomandibular joint disorder. Methods: 33 patients with myofascial pain due to temporomandibular joint disorder were included in the study. The patients were divided into three groups by simple randomization (Kinesiotaping group, Stretching group and Control group). Patients in the Kinesiotaping and Stretching groups received application for their Upper Trapezius and Sternocleidomastoid muscles twice a week for two weeks by the same physiotherapist. No application was made to the Control group. Cervical joint range of motion, muscle strength and pain were evaluated. Additionally, algometry tests and functional evaluation were performed. The tests were performed in the Kinesiotaping and Stretching groups before the applications and at the end of week 1 and week 2, on the other hand Control group evaluated before the application and at the end of week 2.


Description:

This study is my master's thesis that I conducted in 2018. Our prospective clinical study was approved by the Non-Interventional Ethics Committee. The study was conducted at Dentistry Prosthetic Odontotherapy Outpatient Clinic between February 2018 and April 2018. Volunteering 33 patients between the ages of 18 to 60 years and who applied clinics and were diagnosed with myofascial pain due to TMJ disorder according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) classification were included in the study. The patients were divided into groups using simple randomization method. There are 11 patients in groups. Blinding was ensured by patients and dentist were unaware the type of physiotherapy treatment application. Patient evaluation was repeated 3 times: before the treatment, at the end of week 1, and at the end of week 2 of the treatment. In our study, the effects of conservative treatment options used in 'treatment of TMD on 'disease symptoms were examined compared with the control group. A 2-week follow-up was foreseen for the acute impact outcomes of the study.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date July 19, 2018
Est. primary completion date July 19, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Age between 18 and 60 years - Myofascial pain according to RDC/TMD - Natural posterior occlusion and volunteering - Being informed and signing the consent to participate in the research. Exclusion Criteria: - Presence of dentofacial anomalies - Arthralgia - Disk displacement - General inflammatory connective tissue diseases (e.g. rheumatoid arthritis) - Psychiatric disease - Tumor - Orofacial disease symptoms (neuralgia, migraine, etc.) - Local skin infection - Using regular analgesic - Fibromyalgia - History of TMJ-related surgery - Findings of allergy related to Kinesiotape.

Study Design


Intervention

Other:
Kinesiotaping Group
In the Kinesiotaping Group patients had muscle technique-inhibition method. An 'I' shaped tape was used for both SCM and upper trapezius. The tension of the tape was adjusted between 20 and 25% and the application was performed in the longest position of the muscle. The inhibition technique was applied from the insertion to the origin of the muscle. The tape was applied to cover the trigger points where pain was felt. For upper trapezius, the muscle was taped in the opposite direction on the cervical region in lateral flexion, slight flexion, shoulder depression and using the muscle technique with the I tape. For SCM muscle, the tape was applied on the muscle in the opposite direction on the cervical region with positioning in lateral flexion, extension and ipsilateral rotation using the muscle technique with I tape Taping was applied every 3 days and totally in 4 cycles.
Stretching Group
In our application, 3 cycles of 20 seconds of stretches were applied to upper trapezius and SCM muscle. The patient was stretched in a relaxed and supported position and physiotherapist positioned the patient passively for stretching. For the SCM muscle, stretching was achieved in the positions of contralateral lateral flexion, ipsilateral rotation and extension. For upper trapezius, stretching was performed in flexion and lateral flexion. Stretching was performed every 3 days in 4 cycles in total.
Control Group
Control Group patients, after the assessment by the dentist, the treatment method approved by the dentist was performed. The assessment was performed before treatment, at the end of week 1 and at the end of week 2.

Locations

Country Name City State
Turkey Arel University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Arel University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Intensity The subjective pain intensity of the patients was assessed with the Visual Analogue Scale. The Visual Analog Scale includes scoring between 0 and 10. The corresponding numbers from 0 to 10 were explained to the patients. It was explained that the absence of pain was 0, the most severe pain felt was 10, and moderate pain was 5. For the Upper Trapezius and SCM muscle, the patients were asked to mark their resting and functional pain from the scale.Additionally, pain during palpation of the upper trapezius and sternocleidomastoid muscle was assessed with algometry. 2 weeks
Primary Range of Motion The range of motion of the cervical joint was assessed using a goniometer 2 weeks
Primary Research Diagnostic Criteria for Temporomandibular Disorders Klinik degerlendirme formunun içeriginde agrinin nedeni ve agrinin tarafi, agiz açilma sekli ve açilma miktari, eklem sesleri, eksantrik hareket miktarlari ve hareket sirasindaki agri durumlari, eklem sesleri ve kas agrilari palpasyonla degerlendirildi. . 2 week
Primary Muscle Strength Cervical muscle strength was assessed manually 2 week
Primary Mouth Opening Distance The mouth opening of the patients was measured in millimeters for the distance between anterior incisors of the upper and lower jaws. 2 weeks
Secondary The Patient Health Questionnaire The Patient Health Questionnaire was used for comparison in the assessments are two of the subtests of the RDC/TMD questionnaire. The purpose of those tests was to obtain numerical data and to observe the comparison objectively. 2 weeks
Secondary Jaw Functional Limitation Scale It has three levels of functional limitation, including chewing (6 items), jaw mobility (4 items), and verbal and emotional expression (10 items). Each item is rated on a numeric rating scale from 0 to 10. 0, no limitation; 10 indicates severe limitation. 2 weeks
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