Temporomandibular Disorders (TMD)NCT06627855
Effectiveness of the Fascial Distortion Model in Temporomandibular Disorders: A Randomized Sham-controlled Trial
A study testing Fascial Distortion Model in people with Temporomandibular Disorders (TMD) and Manual Therapy, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to investigate the effectiveness of Manual Therapy Based on the Fascial Distortion Model in individuals with temporomandibular disorders compared to sham control. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Temporomandibular Disorders (TMD), Manual Therapy, Fascial Distortion
- What is being tested?
- Fascial Distortion Model
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Oct 2024to Dec 2026
- Phase
- Interventional
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having temporomandibular joint complaints and being diagnosed with temporomandibular disorder according to the Diagnostic Criteria for Temporomandibular Disorders Axis I
- Understand and be willing to answer assessment questions
- A temporomandibular joint complaint for the last three months
- Pain in the jaw, face or neck
Who cannot join
- Has a systemic disease (neurological, rheumatologic, oncologic, etc.) that may affect the temporomandibular joint, cervical spine and/or assessment
- Any history of trauma that may have affected the cranio-cervico-facial region
- Having undergone any surgical intervention in the cranio-cervico-facial region within the last six months
- Receiving surgical treatment, medical treatment, splint therapy or physiotherapy for temporomandibular disorder in the last month
- Radiotherapy in the head and neck region
- Pregnancy or breastfeeding
- Exercise therapy for craniocervical posture for the last month
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Karabük University
Merkez, Karabük Province, 78050
Harun Gençosmanoğlu, PT, MSc, +903704189093, harungencosmanoglu@karabuk.edu.tr
Harun Gençosmanoğlu, PT, MSc
About this study
Official title: Investigation of the Effectiveness of Manual Therapy Based on Fascial Distortion Model in Individuals With Temporomandibular Disorder: A Randomized Sham-controlled Trial
The aim of the study was to investigate the effectiveness of Manual Therapy Based on the Fascial Distortion Model in individuals with temporomandibular disorders compared to sham control. Individuals diagnosed with temporomandibular disorder will be randomly assigned to groups as Group 1 (Manual Therapy Based on Fascial Distortion Model) and Group 2 (Sham Control). Head posture, cervical and temporomandibular joint range of motion, cervical muscle performance, pain intensity, pressure pain thresholds, temporomandibular disorder severity, disability, dysfunction, health-related quality of life, kinesiophobia, and central sensitization will be assessed.
Read the detailed description
Interventions are needed to address head posture, cervical and temporomandibular joint range of motion, cervical muscle performance, pain intensity, pressure pain thresholds, temporomandibular disorder severity, disability, dysfunction, health-related quality of life, kinesiophobia, and central sensitization in individuals with temporomandibular disorder (TMD). This study aims to examine the effectiveness of Manual Therapy Based on the Fascial Distortion Model in individuals with TMDs compared to sham control over a 4-week period. Individuals with TMD will be randomized into Group 1 (Fascial Distortion Model-based Manual Therapy) or Group 2 (Sham Control). Interventions will be conducted once a week in a clinical setting. Head posture will be measured by lateral photogrammetry, cervical range of motion will be measured by an inclinometer, temporomandibular range of motion will be measured by a vernier caliper, cervical muscle performance will be measured by Cervical Spine Functional Strength Test, and pressure pain threshold will be measured by an algometer. Pain intensity will be assessed using the Graded Chronic Pain Scale (Revised) and the Short-Form McGill Pain Questionnaire. TMD severity will be assessed using the Fonseca Anamnestic Index. Mandibular Function Impairment Questionnaire will be used to assess dysfunction. Disability will be evaluated using the Craniofacial Pain and Disability Inventory. Health-related quality of life will be assessed using Short Form-36. Kinesiophobia will be assessed with the Tampa Kinesiophobia Scale; central sensitization will be assessed with the Central Sensitisation Inventory.
All outcomes will be measured at baseline and end of the study, while pain intensity and pressure pain thresholds will also undergo intermediate assessments (2nd and 3rd week).
- Being tested
- Fascial Distortion Model, Sham treatment
- Keywords
- manual therapy, fascial distortion model, temporomandibular disorders, head posture
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascial Distortion ModelProcedure or surgery
Also called Typaldos Manual Therapy
The following techniques were used on the cranial and cervical areas during therapy: Trigger band technique, herniated trigger point technique, continuum technique, folding technique, cylinder technique, and tectonic technique.
Sham treatmentProcedure or surgery
The techniques in the therapy will be applied by imitating the techniques in the therapy for the fascial distortions determined according to the Manual Therapy Based on the Fascial Distortion Model.
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy based Fascial Distortion Model | Active comparator | It will conducted for forty-five minutes once a week in a clinical setting for 4 weeks. Receives: Procedure: Fascial Distortion Model |
| Control | Sham comparator | Sham application will conducted for forty-five minutes once a week in a clinical setting for 4 weeks. Receives: Procedure: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Head posture
Lateral photogrammetry according to Eye-Tragus-Horizontal Angle, Pogonion-Tragus-C7 Angle, Tragus-C7-Horizontal Angle, Tragus-C7-Shoulder Angle, and Shoulder-C7-Horizontal Angle.
Measured: From enrollment to the end of treatment at 4th week
Cervical range of motions
Inclinometric measurements based on flexion, extension, lateral flexions, and rotations.
Measured: From enrollment to the end of treatment at 4th week
Temporomandibular range of motions
Digital vernier caliper measurements based on maximum pain-free mouth opening, maximum possible mouth opening, maximum possible assisted mouth opening, laterotrusions, and protrusion.
Measured: From enrollment to the end of treatment at 4th week
Cervical muscle performance
The Functional Strength Testing of the Cervical Spine was used to evaluate the cervical muscle performance. This is a test that functionally evaluates cervical muscle strength. Results of this test are assessed as functional, functionally fair, functionally poor, and nonfunctional. Six-to-eight repetitions for the flexion test and 20-25 s holding time for the other tests indicate that the test result is functional. Three-to-five repetitions for the flexion test and 10-19 s holding time for the other tests indicate that the test result is functionally fair. One-to-two repetitions for the flexion test and 1-9 s holding time for the other tests indicate that the test result is functionally poor. Zero repetition for the flexion test and 0 s holding time for the other tests indicate that the test result is nonfunctional. Each test was terminated at onset of pain, and the relevant value was recorded.
Measured: From enrollment to the end of treatment at 4th week
Pressure pain threshold
Algometer. Tempormandibular joint, masseter, temporalis anterior, suboccipital muscle, trapezius, lateral epicondyle for both side.
Measured: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.
Pain intensity in the last week
Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.
Chronic pain intensity
Graded Chronic Pain Scale (Revised). Scoring: Grade 1=mild, Grade 2=bothersome, Grade 3=high impact chronic pain. Higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.
Temporomandibular disorders severity
Fonseca Anamnestic Index. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 4th week
Dysfunction
Mandibular Function Impairment Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 4th week
Disability
Craniofacial Pain and Disability Inventory. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 4th week
Health-related quality of life
Short Form-36. Its subdomains are physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health.
Measured: From enrollment to the end of treatment at 4th week
Kinesiophobia
Tampa Kinesiophobia Scale for Temporomandibular Disorders. Minimum and maximum values are 1 and 4 points, respectively. Higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 4th week
Central sensitization
Central Sensitisation Inventory. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 4th week
Present pain intensity
Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.
Present pain intensity (ordinal)
Present pain intensity scale of McGill Pain Questionnaire. Minimum and maximum values are 0 and 5 points, respectively. Higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.
Pain intensity in the last week (ordinal)
Numeric Pain Rating Scale. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start3 Oct 2024
- Primary completion15 Dec 2024
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMD)Studies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harun Gençosmanoğlu, Karabuk University
- Investigators
- Harun Gençosmanoğlu, PT, MSc, Principal investigator, Karabük University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627855
- Sponsor's protocol ID
- 2024/1627
- Status last verified
- Oct 2025
- First submitted
- 3 Oct 2024
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No