NCT05673642

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

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

First Submitted

Initial submission to the registry

December 21, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

December 23, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2023

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

1 month

First QC Date

December 21, 2022

Last Update Submit

June 19, 2025

Conditions

Keywords

TMJ Disorder, Myofascial Release, Low back pain

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (2)

  • DC-TMD Evoluation

    10 minute

  • Oswestry Low Back Disability Survey

    10 minute

Study Arms (3)

Working group

EXPERIMENTAL

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

Other: Myofascial Release Techniques

Exercise group

EXPERIMENTAL

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

Other: Myofascial Release Techniques

Control group

EXPERIMENTAL

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

Other: Myofascial Release Techniques

Interventions

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

Also known as: Myofascial Exercise
Control groupExercise groupWorking group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, 34820, Turkey (Türkiye)

Location

Related Publications (1)

  • Senel Topaloglu E, Budak M, Atilgan E, Kurt H. Effect of myofascial release therapy applied to selective muscles on mobility and function in patients with temporomandibular dysfunction and co-occurring chronic low back pain: A randomized controlled trial. Medicine (Baltimore). 2025 Aug 22;104(34):e44086. doi: 10.1097/MD.0000000000044086.

MeSH Terms

Conditions

Temporomandibular Joint DisordersLow Back Pain

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ebru Senel topaloglu, 1

    Istanbul Medipol University Turkey Istanbul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This study was conducted as a single-blind randomized controlled trial, where participants were unaware of their group assignments. The care provider, investigator, and outcome assessor were also blinded to the group allocation to minimize assessment bias. The randomization process was conducted independently to ensure allocation concealment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A parallel-group randomized controlled trial with three distinct arms.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student.

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 6, 2023

Study Start

December 23, 2022

Primary Completion

January 25, 2023

Study Completion

June 24, 2023

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

I will publish my manuscript about this study, so researchers can access my individual participant data with this way.

Locations