NCT06627855

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Karabuk University · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2024-10-03
• Primary completion: 2024-12-15
• Completion: 2025-12-01
• First posted: 2024-10-04
• Last updated: 2025-03-12

Locations

1 site across 1 country: Turkey (Türkiye)