Temporomandibular Joint DisorderNCT05673642
Myofascial Release Therapy for TMD Pain: A Randomized Trial
A study testing Myofascial Release Techniques in people with Temporomandibular Joint Disorder and Low Back Pain, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorder, Low Back Pain, Myofascial Release
- What is being tested?
- Myofascial Release Techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Dec 2022to 24 Jun 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Myofascial Release Therapy Applied to Selective Muscles on Mobility and Function in Patients With Temporomandibular Dysfunction: A Randomized Controlled Trial
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.
Read the 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
- Being tested
- Myofascial Release Techniques
- Keywords
- TMJ Disorder, Myofascial Release, Low back pain
- Medical subject headings
- Temporomandibular Joint Disorders, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial Release TechniquesOther
Also called Myofascial Exercise
Myofascial Release Technique (MFR), which we will apply to the muscles we choose related to the facial system connection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: Myofascial Release Techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 minute
Secondary outcomes (2)
DC-TMD Evoluation
The amount of mouth opening will be used to evaluate mandibular lateral shifts and mandibular protrusion.
Measured: 10 minute
Oswestry Low Back Disability Survey
To be used to assess functional disability for the lower back
Measured: 10 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start23 Dec 2022
- Primary completion25 Jan 2023
- Study completion24 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint 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
- Model description
- A parallel-group randomized controlled trial with three distinct arms.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Senel T, Istanbul Medipol University Hospital
- Investigators
- Ebru Senel topaloglu, 1, Principal investigator, Istanbul Medipol University Turkey Istanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673642
- Sponsor's protocol ID
- E-10840098-772.02-6577
- Status last verified
- Jun 2025
- First submitted
- 21 Dec 2022
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I will publish my manuscript about this study, so researchers can access my individual participant data with this way.
Publications
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.
PubMed 40859519
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Myofascial Release Therapy Applied to Selective Muscles on Mobility and Function in Patients With Temporomandibular Dysfunction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05673642
- Acronym / sponsor ID
- E-10840098-772.02-6577
- Keywords
- TMJ Disorder, Myofascial Release, Low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 23 Dec 2022 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 24 Jun 2023 (actual)
- First posted
- 6 Jan 2023 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A parallel-group randomized controlled trial with three distinct arms.
| Arm | Type | Receives |
|---|---|---|
| Working group | Experimental | Other: Myofascial Release TechniquesA 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 |
| Exercise group | Experimental | Other: Myofascial Release TechniquesThe 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 |
| Control group | Experimental | Other: Myofascial Release TechniquesNo 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Neurological problems,
- Presence of extruded and sequestered lumbar disc herniation
- Cardiovascular symptoms and circulation problems,
- Infection,
- Fibromyalgia, Acute arthritis conditions
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 |
|---|---|---|
| Myofascial Release TechniquesAlso: Myofascial ExerciseMyofascial Release Technique (MFR), which we will apply to the muscles we choose related to the facial system connection | Other | Control group, Exercise group, Working group |
Primary outcome
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.
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.
2 secondary outcomes
DC-TMD Evoluation
Time frame: 10 minute
Oswestry Low Back Disability Survey
Time frame: 10 minute
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 25 Jun 2025.
- Derived from this study: PubMed 40859519Senel 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.
- Individual participant dataSharing planned: No. I will publish my manuscript about this study, so researchers can access my individual participant data with this way.
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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.
Ebru Senel topaloglu, 1 principal investigator
Istanbul Medipol University Turkey Istanbul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial Release Techniques in people with Temporomandibular Joint Disorder and Low Back Pain, run by Istanbul Medipol University Hospital 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 5 inclusion and 7 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 25 Jun 2025. 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?
Algometer (time frame: 5 minute). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05673642, which also lists 1 linked publication.
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 25 Jun 2025.