search
Back to results

Effect of Myofascial Release Technique Applied to in Patients With Temporomandibular Dysfunction

Primary Purpose

Temporomandibular Joint Disorder, Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Myofascial Release Techniques
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorder focused on measuring TMJ Disorder, Myofascial Release, Low back pain

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Istanbul Medipol UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Working group

Exercise group

Control group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Algometer
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.
Myotonometry
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.
Oswestry Low Back Disability Survey
To be used to assess functional disability for the lower back

Secondary Outcome Measures

DC-TMD Evoluation
The amount of mouth opening will be used to evaluate mandibular lateral shifts and mandibular protrusion.

Full Information

First Posted
December 21, 2022
Last Updated
December 21, 2022
Sponsor
Istanbul Medipol University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05673642
Brief Title
Effect of Myofascial Release Technique Applied to in Patients With Temporomandibular Dysfunction
Official Title
Effect of Myofascial Release Technique Applied to in Patients With TMD
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
January 15, 2023 (Anticipated)
Study Completion Date
January 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

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

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorder, Low Back Pain
Keywords
TMJ Disorder, Myofascial Release, Low back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Working group
Arm Type
Experimental
Arm Description
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
Arm Title
Exercise group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Myofascial Release Techniques
Other Intervention Name(s)
Myofascial Exercise
Intervention Description
Myofascial Release Technique (MFR), which we will apply to the muscles we choose related to the facial system connection
Primary Outcome Measure Information:
Title
Algometer
Description
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.
Time Frame
5 minute
Title
Myotonometry
Description
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.
Time Frame
10 minute
Title
Oswestry Low Back Disability Survey
Description
To be used to assess functional disability for the lower back
Time Frame
10 minute
Secondary Outcome Measure Information:
Title
DC-TMD Evoluation
Description
The amount of mouth opening will be used to evaluate mandibular lateral shifts and mandibular protrusion.
Time Frame
10 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ebru SenelTopaloglu, 1
Phone
+905058598098
Email
fzt.senel@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Esra Atılgan, 2
Phone
+905053855816
Email
eatilgan@medipol.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebru Senel topaloglu, 1
Organizational Affiliation
Istanbul Medipol University Turkey Istanbul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
ZIP/Postal Code
34820
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ebru Senel Topaloglu
Phone
+905058598098
Email
fzt.senel@gmail.com
First Name & Middle Initial & Last Name & Degree
Esra Atılgan
Phone
+905053855816
Email
eatilgan@medipol.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
I will publish my manuscript about this study, so researchers can access my individual participant data with this way.

Learn more about this trial

Effect of Myofascial Release Technique Applied to in Patients With Temporomandibular Dysfunction

We'll reach out to this number within 24 hrs