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

Not Applicable

Completed

• Conditions: Temporomandibular Joint Dysfunction; Manual Therapy; Temporomandibular Joint Disorders; Core Stabilization Exercise Therapy; Temporomandibular Disorders; Temporomandibular Disorder; Temporomandibular Joint Dysfunction Syndrome
• Interventions: Procedure: Fascial Distortion Model; Procedure: Rocabado's 6x6 Exercises; Behavioral: Patient Education; Procedure: Core Stabilization Training

• Registration Number: NCT06186817
• Lead Sponsor: Hacettepe University

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2023-12-17
• Study First Submitted: 2023-12-17
• Study First Submitted QC: 2023-12-17
• Study First Posted: 2024-01-02
• Primary Completion: 2024-03-30
• Status Verified: 2024-07
• Study Completion: 2025-01-02
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Having a temporomandibular joint complaint that has persisted for three months
• Being diagnosed with temporomandibular disorder according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I
• Comprehension and interest in responding to assessment questions

Exclusion Criteria

• Having a systemic condition (neurological, rheumatological, oncological, etc.) that could 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 regions in the previous six months
• Receiving any surgical treatment, medical treatment, or physiotherapy for temporomandibular 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual Therapy based Fascial Distortion Model	Fascial Distortion Model	All participants were given manual therapy based on the Fascial Distortion Model in addition to conventional therapy (Rocabado's 6x6 Exercises and Patient Education). Conventional therapy was implemented as a home program for 8 weeks, while Manual Therapy was conducted for forty-five minutes once a week in a clinical setting.
Core Stabilization Training	Rocabado's 6x6 Exercises	All participants were given manual therapy based on the Core Stabilization Training in addition to conventional therapy (Rocabado's 6x6 Exercises and Patient Education). Conventional therapy was implemented as a home program for 8 weeks, while Core Stabilization Training was conducted for forty-five minutes once a week in a clinical setting.
Core Stabilization Training	Core Stabilization Training	All participants were given manual therapy based on the Core Stabilization Training in addition to conventional therapy (Rocabado's 6x6 Exercises and Patient Education). Conventional therapy was implemented as a home program for 8 weeks, while Core Stabilization Training was conducted for forty-five minutes once a week in a clinical setting.
Manual Therapy based Fascial Distortion Model	Rocabado's 6x6 Exercises	All participants were given manual therapy based on the Fascial Distortion Model in addition to conventional therapy (Rocabado's 6x6 Exercises and Patient Education). Conventional therapy was implemented as a home program for 8 weeks, while Manual Therapy was conducted for forty-five minutes once a week in a clinical setting.
Core Stabilization Training	Patient Education	All participants were given manual therapy based on the Core Stabilization Training in addition to conventional therapy (Rocabado's 6x6 Exercises and Patient Education). Conventional therapy was implemented as a home program for 8 weeks, while Core Stabilization Training was conducted for forty-five minutes once a week in a clinical setting.
Manual Therapy based Fascial Distortion Model	Patient Education	All participants were given manual therapy based on the Fascial Distortion Model in addition to conventional therapy (Rocabado's 6x6 Exercises and Patient Education). Conventional therapy was implemented as a home program for 8 weeks, while Manual Therapy was conducted for forty-five minutes once a week in a clinical setting.

Primary Outcome Measures

Name	Time	Method
Pogonion-Tragus-C7 Angle on lateral photography of head posture	From enrollment to the end of treatment at 8 weeks	The angle between the line connecting the pogonion (the most protruding point on the front of the mandible) to the tragus and the line connecting the tragus to the C7 vertebra
Tragus-C7-Horizontal Angle on lateral photography of head posture	From enrollment to the end of treatment at 8 weeks	The angle between the line connecting the tragus to the C7 vertebra and the horizontal line emerging from the C7 vertebra level. It refers to the neck inclination angle
Disability based on Neck Disability Index	From enrollment to the end of treatment at 8 weeks	Neck Disability Index. Minimum and maximum values are 0 and 5 points, respectively. Higher scores mean a worse outcome.
Cervical active range of motion	From enrollment to the end of treatment at 8 weeks	Dijital inclinometric measurements. Flexion, extension, right and left lateral flexions and right and left rotations.
Neck pain intensity at last seven days based on Short-Form McGill Pain Questionnaire	Baseline, 2nd week, 4th week, 6th week and 8th week	Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
Present neck pain intensity (ordinal)	Baseline, 2nd week, 4th week, 6th week and 8th week	Present pain intensity scale of McGill Pain Questionnaire. Minimum and maximum values are 0 and 5 points, respectively. Higher scores mean a worse outcome.
Eye-Tragus-Horizontal Angle on lateral photography of head posture	From enrollment to the end of treatment at 8 weeks	The angle between the line connecting the midpoint of the lateral corner of the eye to the tragus of ear and the horizontal line emerging from the tragus level. It refers to the cranial rotation angle
Tragus-C7-Shoulder Angle on lateral photography of head posture	From enrollment to the end of treatment at 8 weeks	The angle between the line connecting the acromion to the C7 vertebra and the line connecting the C7 vertebra to the tragus. It refers to the sum of the tragus-C7-horizontal angle and the shoulder-C7-horizontal angle; Shoulder-C7-Horizontal Angle (5): The angle between the line connecting the acromion to the C7 vertebra and the horizontal line emerging from the C7 vertebra level. It refers to the angle of the shoulder.
Shoulder-C7-Horizontal Angle on lateral photography of head posture	From enrollment to the end of treatment at 8 weeks	The angle between the line connecting the acromion to the C7 vertebra and the horizontal line emerging from the C7 vertebra level. It refers to the angle of the shoulder.
Quality of Life based on Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire	From enrollment to the end of treatment at 8 weeks	Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.
Chronic neck pain intensity	Baseline, 2nd week, 4th week, 6th week and 8th week	Graded Chronic Pain Scale (Revised). Scoring: Grade 1=mild, Grade 2=bothersome, Grade 3=high impact chronic pain. Higher scores mean a worse outcome.
Present neck pain intensity	Baseline, 2nd week, 4th week, 6th week and 8th week	Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome.
Neck pain intensity at last seven days based on Numeric Pain Rating Scale	Baseline, 2nd week, 4th week, 6th week and 8th week	Numeric Pain Rating Scale. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Hand grip strength	From enrollment to the end of treatment at 8 weeks	An hand dynamometer will be used to measure grip strength. Two measurements will taken with a 30-second rest between each trial, and the average of the three measurements will be recorded.
Cervical muscle performance	From enrollment to the end of treatment at 8 weeks	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.

Trial Locations

Locations (2)

Hacettepe University; 🇹🇷 Ankara, Turkey

Karabük University; 🇹🇷 Karabük, Turkey