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

NCT06627855 | Recruiting

• 1 other identifier: 2024/1627
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Temporomandibular Disorders (TMD); Manual Therapy; Fascial Distortion

Keywords

manual therapy; fascial distortion model; temporomandibular disorders; head posture

Outcome Measures

Primary Outcomes (16)

• 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.

Study Arms (2)

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.

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.

Procedure: Sham treatment

Interventions

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.

Also known as: Typaldos Manual Therapy

Manual Therapy based Fascial Distortion Model

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.

Control

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karabuk University: lead

Study Sites (1)

Karabük University

Merkez, Karabük Province, 78050, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Harun Gençosmanoğlu, PT, MSc

  Karabük University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harun Gençosmanoğlu, PT, MSc

CONTACT

+903704189093; harungencosmanoglu@karabuk.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 4, 2024
• Study Start: October 3, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 1, 2025
• Last Updated: March 12, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)