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Kinesiotaping and Stretching on SKM and Upper Trapezius Muscle in TMD Patients

Primary Purpose

TMJ Disc Disorder, Myofascial Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesiotaping Group
Stretching Group
Control Group
Sponsored by
Istanbul Arel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for TMJ Disc Disorder focused on measuring Temporomandibular pain, Kinesiotape, Stretching

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Arel University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Kinesiotaping Group

Stretching Group

Control Group

Arm Description

In the Kinesiotaping Group patients had muscle technique-inhibition method. An 'I' shaped tape was used for both SCM and upper trapezius.

The patient was stretched in a relaxed and supported position and physiotherapist positioned the patient passively for stretching.

Control Group patients, after the assessment by the dentist, the treatment method approved by the dentist was performed.

Outcomes

Primary Outcome Measures

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.
Range of Motion
The range of motion of the cervical joint was assessed using a goniometer
Research Diagnostic Criteria for Temporomandibular Disorders
Klinik değerlendirme formunun içeriğinde ağrının nedeni ve ağrının tarafı, ağız açılma şekli ve açılma miktarı, eklem sesleri, eksantrik hareket miktarları ve hareket sırasındaki ağrı durumları, eklem sesleri ve kas ağrıları palpasyonla değerlendirildi. .
Muscle Strength
Cervical muscle strength was assessed manually
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 27, 2022
Last Updated
July 29, 2022
Sponsor
Istanbul Arel University
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1. Study Identification

Unique Protocol Identification Number
NCT05481268
Brief Title
Kinesiotaping and Stretching on SKM and Upper Trapezius Muscle in TMD Patients
Official Title
Comparative Efficacy of Kinesiotaping and Stretching on Sternocleidomastoid and Upper Trapezius Muscles in Patients Suffering From Myofascial Pain Due to Temporomandibular Joint Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
July 19, 2018 (Actual)
Study Completion Date
July 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Arel University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TMJ Disc Disorder, Myofascial Pain
Keywords
Temporomandibular pain, Kinesiotape, Stretching

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesiotaping Group
Arm Type
Experimental
Arm Description
In the Kinesiotaping Group patients had muscle technique-inhibition method. An 'I' shaped tape was used for both SCM and upper trapezius.
Arm Title
Stretching Group
Arm Type
Experimental
Arm Description
The patient was stretched in a relaxed and supported position and physiotherapist positioned the patient passively for stretching.
Arm Title
Control Group
Arm Type
Other
Arm Description
Control Group patients, after the assessment by the dentist, the treatment method approved by the dentist was performed.
Intervention Type
Other
Intervention Name(s)
Kinesiotaping Group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Stretching Group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
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.
Time Frame
2 weeks
Title
Range of Motion
Description
The range of motion of the cervical joint was assessed using a goniometer
Time Frame
2 weeks
Title
Research Diagnostic Criteria for Temporomandibular Disorders
Description
Klinik değerlendirme formunun içeriğinde ağrının nedeni ve ağrının tarafı, ağız açılma şekli ve açılma miktarı, eklem sesleri, eksantrik hareket miktarları ve hareket sırasındaki ağrı durumları, eklem sesleri ve kas ağrıları palpasyonla değerlendirildi. .
Time Frame
2 week
Title
Muscle Strength
Description
Cervical muscle strength was assessed manually
Time Frame
2 week
Title
Mouth Opening Distance
Description
The mouth opening of the patients was measured in millimeters for the distance between anterior incisors of the upper and lower jaws.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
The Patient Health Questionnaire
Description
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.
Time Frame
2 weeks
Title
Jaw Functional Limitation Scale
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozge Baykan Copuroglu, MSc
Organizational Affiliation
Istanbul Arel University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arel University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

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Kinesiotaping and Stretching on SKM and Upper Trapezius Muscle in TMD Patients

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