Efficacy of Manual Therapy Based on the Fascial Distortion Model in Individuals With Temporomandibular Disorder

Study Overview
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Brief Summary
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The goal of this randomized clinical trial is to investigate the efficacy of Manual Therapy Based on the Fascial Distortion Model (FDM) 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 efficacy of the addition of FDM-based Manual Therapy to conventional therapy different from the addition of CST or control? Is the efficacy 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. Pain intensity, TMD severity, head posture, function, and disability will be assessed.

Detailed Description
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Interventions are needed to address pain intensity, temporomandibular disorder severity, head posture, function, and disability levels in individuals with temporomandibular disorder (TMD). This study aims to examine the efficacy 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. Pain intensity will be assessed using the Graded Chronic Pain Scale (Revised) and the Short-Form McGill Pain Questionnaire. TMD severity and head posture will be assessed using the Fonseca Anamnestic Index and lateral photography, respectively. Mandibular Function Impairment Questionnaire and temporomandibular joint range of motions will be used to assess function. Disability will be evaluated using the Craniomandibular Pain and Disability Inventory and the Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire. All outcomes will be measured at baseline and end of the study, while pain intensity will also undergo intermediate assessments (2nd, 4th, and 6th weeks).

Official Title
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Investigation of the Efficacy of Manual Therapy Based on the Fascial Distortion Model in Individuals With Temporomandibular Disorder

Conditions
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Temporomandibular Disorder, Temporomandibular Joint Dysfunction Syndrome, Temporomandibular Joint Disorders, Temporomandibular Joint Pain, Temporomandibular Joint Disc Displacement, Manual Therapy

Intervention / Treatment
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* Procedure: Fascial Distortion Model
* Procedure: Core Stabilization Training
* Procedure: Rocabado's 6x6 Exercises
* Behavioral: Patient Education


Participation Criteria
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Eligibility Criteria
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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 region 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manual Therapy based Fascial Distortion Model<br>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. | Procedure: Fascial Distortion Model<br>* 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.<br>Procedure: Rocabado's 6x6 Exercises<br>* Resting position of the tongue, rotational control of temporomandibular joint, rhythmic stabilization, axial extension of the neck, shoulder posture, and stabilized head flexion<br>Behavioral: Patient Education<br>* Participants are instructed to perform some behaviors while avoiding others based on the etiology of temporomandibular disorders.<br>|
| Active Comparator: Core Stabilization Training<br>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. | Procedure: Core Stabilization Training<br>* Week 1st (1 x 10 reps): Supine deep cervical activation, supine deep lumbar activation, prone deep cervical activation, prone deep lumbar activation, supine combined deep cervical and lumbar activation, and prone combined deep cervical and lumbar activation; Week 2nd (1 x 10 reps): Arm openings, hundreds 1, one leg stretch 1, double leg stretch 1, shoulder bridge, breaststroke, leg pull prone prep 1; Week 3rd (1 x 10 reps): Arm openings, hundreds 2, one leg stretch 2, double leg stretch 2, shoulder bridge, breaststroke, leg pull prone prep 2; Week 4th (1 x 10 reps): Arm openings, hundreds 2, one leg stretch 2, double leg stretch 3, shoulder bridge, breaststroke, leg pull prone prep 2; Week 5th to 8th (with Resistance Band; 1 x 10 reps): Arm openings, shoulder bridge, swan dive, scapula isolations, plough, biceps curl, roll up, roll up with biceps, roll up with rowing, seated spine twist, swimming in kneeling, one leg kick in kneeling and diamond press in standing<br>* Other names: Spinal Stabilization Training;Procedure: Rocabado's 6x6 Exercises<br>* Resting position of the tongue, rotational control of temporomandibular joint, rhythmic stabilization, axial extension of the neck, shoulder posture, and stabilized head flexion<br>Behavioral: Patient Education<br>* Participants are instructed to perform some behaviors while avoiding others based on the etiology of temporomandibular disorders.<br>|
| No Intervention: Control<br>No participant was given any therapy during the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eye-Tragus-Horizontal Angle on lateral photography of head posture | 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 | Baseline | 
| Eye-Tragus-Horizontal Angle on lateral photography of head posture | 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 | 8th week | 
| Pogonion-Tragus-C7 Angle on lateral photography of head posture | 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 | Baseline | 
| Pogonion-Tragus-C7 Angle on lateral photography of head posture | 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 | 8th week | 
| Tragus-C7-Horizontal Angle on lateral photography of head posture | 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 | Baseline | 
| Tragus-C7-Horizontal Angle on lateral photography of head posture | 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 | 8th week | 
| Tragus-C7-Shoulder Angle on lateral photography of head posture | 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. | Baseline | 
| Tragus-C7-Shoulder Angle on lateral photography of head posture | 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. | 8th week | 
| Shoulder-C7-Horizontal Angle on lateral photography of head posture | 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. | Baseline | 
| Shoulder-C7-Horizontal Angle on lateral photography of head posture | 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. | 8th week | 
| Disability based on Craniomandibular Pain and Disability Inventory | Craniomandibular Pain and Disability Inventory. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome. | Baseline | 
| Disability based on Craniomandibular Pain and Disability Inventory | Craniomandibular Pain and Disability Inventory. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome. | 8th week | 
| Disability based on Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire | Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome. | Baseline | 
| Disability based on Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire | Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome. | 8th 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. | Baseline | 
| 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. | 2nd 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. | 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. | 6th 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. | 8th week | 
| Pain intensity at last seven days based on Short-Form McGill Pain Questionnaire | Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome. | Baseline | 
| Pain intensity at last seven days based on Short-Form McGill Pain Questionnaire | Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome. | 2nd week | 
| Pain intensity at last seven days based on Short-Form McGill Pain Questionnaire | Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome. | 4th week | 
| Pain intensity at last seven days based on Short-Form McGill Pain Questionnaire | Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome. | 6th week | 
| Pain intensity at last seven days based on Short-Form McGill Pain Questionnaire | Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome. | 8th week | 
| Present pain intensity | Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome. | Baseline | 
| Present pain intensity | Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome. | 2nd week | 
| Present pain intensity | Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome. | 4th week | 
| Present pain intensity | Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome. | 6th week | 
| Present pain intensity | Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome. | 8th 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. | Baseline | 
| 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. | 2nd 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. | 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. | 6th 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. | 8th week | 
| Pain intensity at last seven days based on Numeric Pain Rating Scale | Numeric Pain Rating Scale. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome. | Baseline | 
| Pain intensity at last seven days based on Numeric Pain Rating Scale | Numeric Pain Rating Scale. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome. | 2nd week | 
| Pain intensity at last seven days based on Numeric Pain Rating Scale | Numeric Pain Rating Scale. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome. | 4th week | 
| Pain intensity at last seven days based on Numeric Pain Rating Scale | Numeric Pain Rating Scale. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome. | 6th week | 
| Pain intensity at last seven days based on Numeric Pain Rating Scale | Numeric Pain Rating Scale. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome. | 8th week | 
| Temporomandibular disorder severity | Fonseca Anamnestic Index. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome. | Baseline | 
| Temporomandibular disorder severity | Fonseca Anamnestic Index. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome. | 8th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function | Mandibular Function Impairment Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome. | Baseline | 
| Function | Mandibular Function Impairment Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome. | 8th week | 
| Temporomandibular joint range of motions | Dijital caliper measurements | Baseline | 
| Temporomandibular joint range of motions | Dijital caliper measurements | 8th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fascial Distortion Model, Core Stabilization Training