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

Karabuk University

Status: Enrolling

Conditions: Temporomandibular Disorders (TMD); Fascial Distortion; Manual Therapy

Treatments: Procedure: Fascial Distortion Model; Procedure: Sham treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06627855

2024/1627

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Manual Therapy based Fascial Distortion Model

Active Comparator group

Description:

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

Treatment:

Procedure: Fascial Distortion Model

Control

Sham Comparator group

Description:

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

Treatment:

Procedure: Sham treatment