- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05673642
Effect of Myofascial Release Technique Applied to in Patients With Temporomandibular Dysfunction
Effect of Myofascial Release Technique Applied to in Patients With TMD
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
We aim to compare the effectiveness of MFR and exercise therapy on mobility and function by investigating the effectiveness of the Myofascial Release Technique (MFR), which we will apply to the muscles we choose related to the facial system connection in participants with temporomandibular dysfunction (TMD) and low back pain.
Method and Material Working group (Group A): Myofascial release technique will be applied. A total of 10 sessions will be applied for 4 weeks, 3 times a week for the first 2 weeks, and 2 times a week for the next 2 weeks.
Exercise group (Group B): The stretching exercises that we planned to give to the exercise group were planned for the muscles to which we will apply myofascial technique.
• Control group (Group C): No application will be made to the control group. Evaluations will be made at the beginning of the study and at the end of 4 weeks. The evaluation parameters to be used are as follows; Oswestry Low Back Disability Survey, Algometer and Myotonometry.
Inclusion Criteria: Participants aged 18-50 years diagnosed with TMD,Persons with a score of 20% or more on the Oswestry waist index, and People with low back pain for more than 3 months,Persons with mechanical low back pain and lumbar disc herniation without neurological deficits will be included in the study.Persons with acute or chronic temporomandibular dysfunction will be included. Exclusion Criteria; Neurological problems,Presence of extruded and sequestered lumbar disc herniation,Cardiovascular symptoms and circulation problems,Infection,Fibromyalgia, Acute arthritis conditions,Those with spinal abnormalities,Fracture history, presence of dislocation / subluxation will be excluded
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ebru SenelTopaloglu, 1
- Phone Number: +905058598098
- Email: fzt.senel@gmail.com
Study Contact Backup
- Name: Esra Atılgan, 2
- Phone Number: +905053855816
- Email: eatilgan@medipol.edu.tr
Study Locations
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-
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Istanbul, Turkey, 34820
- Recruiting
- Istanbul Medipol University
-
Contact:
- Ebru Senel Topaloglu
- Phone Number: +905058598098
- Email: fzt.senel@gmail.com
-
Contact:
- Esra Atılgan
- Phone Number: +905053855816
- Email: eatilgan@medipol.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants aged 18-50 years diagnosed with TMD
- Persons with a score of 20% or more on the Oswestry waist index, and
- People with low back pain for more than 3 months
- Persons with mechanical low back pain and lumbar disc herniation without neurological deficits will be included in the study.
- Persons with acute or chronic temporomandibular dysfunction will be included
Exclusion Criteria:
- Neurological problems,
- Presence of extruded and sequestered lumbar disc herniation
- Cardiovascular symptoms and circulation problems,
- Infection,
- Fibromyalgia, Acute arthritis conditions
- Those with spinal abnormalities,
- Fracture history, presence of dislocation / subluxation will be excluded
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Working group
A total of 10 sessions will be applied myofascial release technique for 4 weeks, 3 times a week for the first 2 weeks, and 2 times a week for the next 2 weeks.
Evaluations will be made at the beginning of the study and at the end of 4 weeks
|
Myofascial Release Technique (MFR), which we will apply to the muscles we choose related to the facial system connection
Other Names:
|
Experimental: Exercise group
The stretching exercises that we planned to give to the exercise group were planned for the muscles to which we will apply myofascial technique.
Evaluations will be made at the beginning of the study and at the end of 4 weeks
|
Myofascial Release Technique (MFR), which we will apply to the muscles we choose related to the facial system connection
Other Names:
|
Experimental: Control group
No application will be made to the control group.
Evaluations will be made at the beginning of the study and at the end of 4 weeks
|
Myofascial Release Technique (MFR), which we will apply to the muscles we choose related to the facial system connection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Algometer
Time Frame: 5 minute
|
Pressure algometer will be used for temporomandibular joint pain.
It will be applied to the lower masseter muscles and anterior temporalis muscles bilaterally on the lateral pole of the algometer and the average of three applications in each region will be taken.
|
5 minute
|
Myotonometry
Time Frame: 10 minute
|
It will be used to assess muscle tone differences.
Myotonometry provides valid and reliable measurement of tissue stiffness.
The measurement will be applied bilaterally to the masseter, temporalis, trapezius, erector spinal muscles, quadrates lumborum and TFL muscles.
|
10 minute
|
Oswestry Low Back Disability Survey
Time Frame: 10 minute
|
To be used to assess functional disability for the lower back
|
10 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DC-TMD Evoluation
Time Frame: 10 minute
|
The amount of mouth opening will be used to evaluate mandibular lateral shifts and mandibular protrusion.
|
10 minute
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ebru Senel topaloglu, 1, Istanbul Medipol University Turkey Istanbul
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Stomatognathic Diseases
- Jaw Diseases
- Craniomandibular Disorders
- Mandibular Diseases
- Myofascial Pain Syndromes
- Back Pain
- Low Back Pain
- Joint Diseases
- Temporomandibular Joint Disorders
- Temporomandibular Joint Dysfunction Syndrome
Other Study ID Numbers
- E-10840098-772.02-6577
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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