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NCT Number: NCT06627855

Effectiveness of the Fascial Distortion Model in Temporomandibular Disorders: 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.

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Key information

Conditions

Temporomandibular Disorders (TMD) Craniomandibular Disorders Fascial Distortion Jaw Diseases Joint Diseases Mandibular Diseases Manual Therapy Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karabük University

Merkez, Karabük Province, 78050, Turkey (Türkiye)

Location status: Recruiting

Location contact

Harun Gençosmanoğlu, PT, MSc

CONTACT

[email protected]

+903704189093

Harun Gençosmanoğlu, PT, MSc

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Fascial Distortion Model

Procedure

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.

Other names: Typaldos Manual Therapy

Sham treatment

Procedure

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.

Primary outcomes

  1. Head posture

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

    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.

  2. Cervical range of motions

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

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

  3. Temporomandibular range of motions

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

    Digital vernier caliper measurements based on maximum pain-free mouth opening, maximum possible mouth opening, maximum possible assisted mouth opening, laterotrusions, and protrusion.

  4. Cervical muscle performance

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

    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.

  5. Pressure pain threshold

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

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

  6. Pain intensity in the last week

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

    Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.

  7. Chronic pain intensity

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

    Graded Chronic Pain Scale (Revised). Scoring: Grade 1=mild, Grade 2=bothersome, Grade 3=high impact chronic pain. Higher scores mean a worse outcome.

  8. Temporomandibular disorders severity

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

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

  9. Dysfunction

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

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

  10. Disability

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

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

  11. Health-related quality of life

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

    Short Form-36. Its subdomains are physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health.

  12. Kinesiophobia

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

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

  13. Central sensitization

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

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

  14. Present pain intensity

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

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

  15. Present pain intensity (ordinal)

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

    Present pain intensity scale of McGill Pain Questionnaire. Minimum and maximum values are 0 and 5 points, respectively. Higher scores mean a worse outcome.

  16. Pain intensity in the last week (ordinal)

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

    Numeric Pain Rating Scale. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Harun Gençosmanoğlu, PT, MSc

CONTACT

[email protected]

+903704189093

Sponsors and collaborators

Lead sponsor

Karabuk University

Other

Registry information

Official study title

Investigation of the Effectiveness of Manual Therapy Based on Fascial Distortion Model in Individuals With Temporomandibular Disorder: A Randomized Sham-controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 4, 2024
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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