TMJ Disc DisorderNCT05481268
Kinesiotaping and Stretching on SKM and Upper Trapezius Muscle in TMD Patients
A study testing Kinesiotaping Group and Stretching Group in people with TMJ Disc Disorder and Myofascial Pain, run by Istanbul Arel University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- TMJ Disc Disorder, Myofascial Pain
- What is being tested?
- Kinesiotaping Group and Stretching Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2018to 19 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Presence of dentofacial anomalies
- Arthralgia
- Disk displacement
- General inflammatory connective tissue diseases (e.g. rheumatoid arthritis)
- Psychiatric disease
- Tumor
Show all 12Show fewer
- Orofacial disease symptoms (neuralgia, migraine, etc.)
- Local skin infection
- Using regular analgesic
- Fibromyalgia
- History of TMJ-related surgery
- Findings of allergy related to Kinesiotape.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- TMJ Disc Disorder, Myofascial Pain
- Being tested
- Kinesiotaping Group, Stretching Group, Control Group
- Keywords
- Temporomandibular pain, Kinesiotape, Stretching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesiotaping GroupOther
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 GroupOther
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Kinesiotaping Group |
| Stretching Group | Experimental | The patient was stretched in a relaxed and supported position and physiotherapist positioned the patient passively for stretching. Receives: Other: Stretching Group |
| Control Group | Other | Control Group patients, after the assessment by the dentist, the treatment method approved by the dentist was performed. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Range of Motion
The range of motion of the cervical joint was assessed using a goniometer
Measured: 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. .
Measured: 2 week
Muscle Strength
Cervical muscle strength was assessed manually
Measured: 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.
Measured: 2 weeks
Secondary outcomes (2)
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.
Measured: 2 weeks
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start15 Mar 2018
- Primary completion19 Jul 2018
- Study completion19 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ Disc DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Arel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozge Baykan Copuroglu, Istanbul Arel University
- Investigators
- Ozge Baykan Copuroglu, MSc, Principal investigator, Istanbul Arel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481268
- Sponsor's protocol ID
- IstanbulArelUTME
- Status last verified
- Jul 2022
- First submitted
- 27 Jul 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05481268
- Acronym / sponsor ID
- IstanbulArelUTME
- Conditions
- TMJ Disc Disorder, Myofascial Pain
- Keywords
- Temporomandibular pain, Kinesiotape, Stretching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Istanbul Arel UniversityUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 19 Jul 2018 (actual)
- Study completion
- 19 Jul 2018 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kinesiotaping Group | Experimental | Other: Kinesiotaping GroupIn the Kinesiotaping Group patients had muscle technique-inhibition method. An 'I' shaped tape was used for both SCM and upper trapezius. |
| Stretching Group | Experimental | Other: Stretching GroupThe patient was stretched in a relaxed and supported position and physiotherapist positioned the patient passively for stretching. |
| Control Group | Other | Other: Control GroupControl Group patients, after the assessment by the dentist, the treatment method approved by the dentist was performed. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- Presence of dentofacial anomalies
- Arthralgia
- Disk displacement
- General inflammatory connective tissue diseases (e.g. rheumatoid arthritis)
- Psychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesiotaping GroupIn 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. | Other | Kinesiotaping Group |
| Stretching GroupIn 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. | Other | Stretching Group |
| Control GroupControl 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. | Other | Control Group |
Primary outcome
Pain Intensity
Time frame: 2 weeks
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
Time frame: 2 weeks
The range of motion of the cervical joint was assessed using a goniometer
Research Diagnostic Criteria for Temporomandibular Disorders
Time frame: 2 week
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
Time frame: 2 week
Cervical muscle strength was assessed manually
Mouth Opening Distance
Time frame: 2 weeks
The mouth opening of the patients was measured in millimeters for the distance between anterior incisors of the upper and lower jaws.
2 secondary outcomes
The Patient Health Questionnaire
Time frame: 2 weeks
Jaw Functional Limitation Scale
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozge Baykan Copuroglu, MSc principal investigator
Istanbul Arel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotaping Group and Stretching Group in people with TMJ Disc Disorder and Myofascial Pain, run by Istanbul Arel University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 2 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.