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

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.

Study Overview

• Status: Recruiting
• Conditions: Manual Therapy; Temporomandibular Disorders (TMD); Fascial Distortion
• Intervention / Treatment: Procedure: Fascial Distortion Model; Procedure: Sham treatment

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).

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Harun Gençosmanoğlu, PT, MSc; Phone Number: +903704189093; Email: harungencosmanoglu@karabuk.edu.tr

Study Locations

• Turkey (Türkiye)
  • Karabük Province
    • Merkez, Karabük Province, Turkey (Türkiye), 78050
      • Recruiting
      • Karabuk University
      • Contact: Harun Gençosmanoğlu, PT, MSc; Phone Number: +903704189093; Email: harungencosmanoglu@karabuk.edu.tr
      • Principal Investigator: Harun Gençosmanoğlu, PT, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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 Comparator: Control; Sham application will conducted for forty-five minutes once a week in a clinical setting for 4 weeks.	Procedure: Sham 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of treatment at 4th week
Cervical range of motions	Inclinometric measurements based on flexion, extension, lateral flexions, and rotations.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.

Collaborators and Investigators

• Sponsor: Karabuk University
• Investigators: Principal Investigator: Harun Gençosmanoğlu, PT, MSc, Karabuk University

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2024
• Primary Completion (Actual): December 15, 2024
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 3, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Actual): August 5, 2026
• Last Update Submitted That Met QC Criteria: August 3, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: manual therapy; temporomandibular disorders; fascial distortion model; head posture
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Muscular Diseases; Joint Diseases; Jaw Diseases; Mandibular Diseases; Craniomandibular Disorders; Temporomandibular Joint Disorders
• Other Study ID Numbers: 2024/1627

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No