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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05673642
Other study ID # E-10840098-772.02-6577
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 10, 2021
Est. completion date January 30, 2023

Study information

Verified date May 2022
Source Istanbul Medipol University Hospital
Contact Ebru SenelTopaloglu, 1
Phone +905058598098
Email fzt.senel@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date January 30, 2023
Est. primary completion date January 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Myofascial Release Techniques
Myofascial Release Technique (MFR), which we will apply to the muscles we choose related to the facial system connection

Locations

Country Name City State
Turkey Istanbul Medipol University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 5 minute
Primary 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. 10 minute
Primary Oswestry Low Back Disability Survey To be used to assess functional disability for the lower back 10 minute
Secondary DC-TMD Evoluation The amount of mouth opening will be used to evaluate mandibular lateral shifts and mandibular protrusion. 10 minute
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