ClinicalTrials.gg
RecruitingNCT06627855Updated Aug 5, 2026

Effectiveness of the Fascial Distortion Model in Temporomandibular Disorders: A Randomized Sham-controlled Trial

An interventional study of Fascial Distortion Model and Sham treatment in Temporomandibular Disorders (TMD), Manual Therapy and Fascial Distortion, sponsored by Karabuk University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by Karabuk University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years 1 month later.

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Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 150 studies in Temporomandibular Joint Disorders with a site in Turkey — 27 open to participants now, 28 under way, none of them phase 3. Temporomandibular Joint Disorders · Turkey.

Planned enrollment
64th of 80
30 · median 45
Started
2024
with 22 others
No phase
76 of 150
13 open now
Primary completion
2024-12
later than 12 of 27 live
Registered
86th of 150
by date

Among the 150 studies in Temporomandibular Joint Disorders with a site in Turkey, this one is the 64th largest by planned enrollment of the 80 interventional ones that give a count, is one of 23 that started in 2024, is one of 76 with no phase, reaches primary completion later than 12 of the 27 other live ones, and was the 86th registered.

Temporomandibular Joint Disorders

591 studies on the registry are indexed under Temporomandibular Joint Disorders; 149 are open to participants now.

Browse Temporomandibular Joint Disorders studies →

Open to participants now

27 of the 150 studies in Temporomandibular Joint Disorders with a site in Turkey are open now. Recruiting first, the newest first:

21 more — sign in →

All 27 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 75 Temporomandibular Joint Disorders studies recruiting now, 26 (35%) set no upper age limit and 45 (60%) stop at 75 or younger; 7 take children under 18; 23 take healthy volunteers.

This study: 18 Years to 64 Years · all sexes · no healthy volunteers.

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02

Study 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. 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).

03

Conditions studied

  • Temporomandibular Disorders (TMD)
  • Manual Therapy
  • Fascial Distortion

Keywords

  • manual therapy
  • fascial distortion model
  • temporomandibular disorders
  • head posture
04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Manual Therapy based Fascial Distortion Model

    It will conducted for forty-five minutes once a week in a clinical setting for 4 weeks.

    Procedure: Fascial Distortion Model

  • Sham comparator
    Control

    Sham application will conducted for forty-five minutes once a week in a clinical setting for 4 weeks.

    Procedure: Sham treatment

Interventions

  • ProcedureFascial Distortion Model

    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.

    Also known as: Typaldos Manual Therapy

  • ProcedureSham treatment

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From enrollment to the end of treatment at 4th week

  2. Cervical range of motions

    Inclinometric measurements based on flexion, extension, lateral flexions, and rotations.

    Time frame: From enrollment to the end of treatment at 4th week

  3. 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.

    Time frame: From enrollment to the end of treatment at 4th week

  4. 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.

    Time frame: From enrollment to the end of treatment at 4th week

  5. Pressure pain threshold

    Algometer. Tempormandibular joint, masseter, temporalis anterior, suboccipital muscle, trapezius, lateral epicondyle for both side.

    Time frame: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.

  6. 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.

    Time frame: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.

  7. 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.

    Time frame: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.

  8. Temporomandibular disorders severity

    Fonseca Anamnestic Index. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.

    Time frame: From enrollment to the end of treatment at 4th week

  9. Dysfunction

    Mandibular Function Impairment Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.

    Time frame: From enrollment to the end of treatment at 4th week

  10. Disability

    Craniofacial Pain and Disability Inventory. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.

    Time frame: From enrollment to the end of treatment at 4th week

  11. 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.

    Time frame: From enrollment to the end of treatment at 4th week

  12. Kinesiophobia

    Tampa Kinesiophobia Scale for Temporomandibular Disorders. Minimum and maximum values are 1 and 4 points, respectively. Higher scores mean a worse outcome.

    Time frame: From enrollment to the end of treatment at 4th week

  13. Central sensitization

    Central Sensitisation Inventory. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.

    Time frame: From enrollment to the end of treatment at 4th week

  14. Present pain intensity

    Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome.

    Time frame: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.

  15. 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.

    Time frame: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.

  16. 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.

    Time frame: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.

07

Study locations

1 of 1 sites recruiting
  • Karabük University
    Merkez, Karabük Province 78050, Turkey (Türkiye)
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2024 to primary completion in Dec 2024, 2 months.

Of 242 non-industry interventional studies with no phase under Temporomandibular Joint Disorders, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 21. This study's 2 months is below that.

Counting every sponsor, half of 246 studies reached it within 10 months; a quarter within 5 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 3, 2024
First posted
Oct 4, 2024
StartActual
Oct 3, 2024
Primary completionActual
Dec 15, 2024
CompletionEst.
Dec 2026
Last update
Aug 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06627855
Lead sponsor
Karabuk University
Responsible party
Harun Gençosmanoğlu (Lecturer, Karabuk University) — Principal investigator
First posted
Oct 4, 2024
Start date
Oct 3, 2024
Primary completion
Dec 15, 2024
Completion
Dec 2026 (estimated)
Last update
Aug 5, 2026

Study contacts

Harun Gençosmanoğlu, PT, MSc
Contact
harungencosmanoglu@karabuk.edu.tr
+903704189093
Harun Gençosmanoğlu, PT, MSc
principal investigator · Karabük University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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