Effectiveness of the Fascial Distortion Model on the Cervical Spine in Individuals with Temporomandibular Disorder

Last updated: March 11, 2025
Sponsor: Hacettepe University
Overall Status: Completed

Phase

N/A

Condition

Oral Facial Pain

Treatment

Core Stabilization Training

Rocabado's 6x6 Exercises

Fascial Distortion Model

Clinical Study ID

NCT06186817
2023/1359
  • Ages 18-64
  • All Genders

Study Summary

The goal of this randomized clinical trial is to investigate the effectiveness of Manual Therapy Based on the Fascial Distortion Model (FDM) on the cervical spine by comparing it with Core Stabilization Training (CST) or Control in individuals with temporomandibular disorders. The main questions it aims to answer are:

Is the effectiveness of the addition of FDM-based Manual Therapy to conventional therapy different from the addition of CST or control? Is the effectiveness of the addition of CST to conventional therapy different from the addition of FDM or control? All participants in the intervention groups will be given eight-week conventional therapy (Rocabado Exercises and Patient Education) in addition to FDM-based Manual Therapy or CST. Participants in the control group will not be given any therapy during the study.

Neck pain intensity, hand grip strength, head posture, cervical muscle performance, cervical range of motion (function), disability, and quality of life will be assessed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Having a temporomandibular joint complaint that has persisted for three months

  • Being diagnosed with temporomandibular disorder according to the Diagnostic Criteriafor Temporomandibular Disorders (DC/TMD) Axis I

  • Comprehension and interest in responding to assessment questions

Exclusion

Exclusion Criteria:

  • Having a systemic condition (neurological, rheumatological, oncological, etc.) thatcould affect the temporomandibular joint and/or interfere with the evaluation

  • History of any trauma that may have affected cranial, cervical, or facial region

  • Having undergone any surgical intervention in cranial, cervical, or facial regionsin the previous six months

  • Receiving any surgical treatment, medical treatment, or physiotherapy fortemporomandibular disorder in the last month

  • Having received radiotherapy in the cranial or cervical region

  • Pregnancy or breastfeeding

  • Exercise for head posture for the last month

Study Design

Total Participants: 51
Treatment Group(s): 4
Primary Treatment: Core Stabilization Training
Phase:
Study Start date:
December 17, 2023
Estimated Completion Date:
January 02, 2025

Study Description

Interventions are needed to address neck pain intensity, hand grip strength, head posture, cervical muscle performance, cervical range of motion (function), disability, and quality of life in individuals with temporomandibular disorder (TMD). This study aims to examine the effectiveness of Fascial Distortion Model-based Manual Therapy compared to Core Stabilization Training or Control in individuals with TMD over an 8-week period. Individuals with TMD will be randomized into Group 1 (Fascial Distortion Model-based Manual Therapy, Rocabado Exercises, and Patient Education), Group 2 (Core Stabilization Training, Rocabado Exercises, and Patient Education), or Group 3 (Control). Rocabado Exercises and Patient Education will be implemented as a home program for 8 weeks, while Fascial Distortion Model-based Manual Therapy and Core Stabilization Training will be conducted once a week in a clinical setting. Neck pain intensity will be assessed using the Graded Chronic Pain Scale (Revised) and the Short-Form McGill Pain Questionnaire. Hand grip strength and head posture will be assessed using a hand dynamometer and lateral photography, respectively. The Functional Strength Testing of the Cervical Spine and cervical range of motions will be used to assess cervical muscle performance and function, respectively. Disability and quality of life will be evaluated using the Neck Disability Index and the Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire. All outcomes will be measured at baseline and end of the study, while neck pain intensity will also undergo intermediate assessments (2nd, 4th, and 6th weeks).

Connect with a study center

  • Hacettepe University

    Ankara, 06100
    Turkey

    Site Not Available

  • Karabük University

    Karabük, 78050
    Turkey

    Site Not Available

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