NCT05481268

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2018

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
Last Updated

August 1, 2022

Status Verified

July 1, 2022

Enrollment Period

4 months

First QC Date

July 27, 2022

Last Update Submit

July 29, 2022

Conditions

Keywords

Temporomandibular painKinesiotapeStretching

Outcome Measures

Primary Outcomes (5)

  • 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

  • Range of Motion

    The range of motion of the cervical joint was assessed using a goniometer

    2 weeks

  • 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. .

    2 week

  • Muscle Strength

    Cervical muscle strength was assessed manually

    2 week

  • 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 Outcomes (2)

  • The Patient Health Questionnaire

    2 weeks

  • Jaw Functional Limitation Scale

    2 weeks

Study Arms (3)

Kinesiotaping Group

EXPERIMENTAL

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

Other: Kinesiotaping Group

Stretching Group

EXPERIMENTAL

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

Other: Stretching Group

Control Group

OTHER

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

Other: Control Group

Interventions

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.

Kinesiotaping 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.

Stretching 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.

Control Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arel University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Ozge Baykan Copuroglu, MSc

    Istanbul Arel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prelector/ Physiotherapist

Study Record Dates

First Submitted

July 27, 2022

First Posted

August 1, 2022

Study Start

March 15, 2018

Primary Completion

July 19, 2018

Study Completion

July 19, 2018

Last Updated

August 1, 2022

Record last verified: 2022-07

Locations