Investigation of the Efficacy of Manual Therapy Based on the Fascial Distortion Model in Individuals With Temporomandibular Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Temporomandibular Disorder
- Sponsor
- Hacettepe University
- Enrollment
- 53
- Locations
- 2
- Primary Endpoint
- Eye-Tragus-Horizontal Angle on lateral photography of head posture
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
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).
Investigators
Harun Gençosmanoğlu
Principal Investigator
Hacettepe University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Eye-Tragus-Horizontal Angle on lateral photography of head posture
Time Frame: 8th week
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
Pogonion-Tragus-C7 Angle on lateral photography of head posture
Time Frame: 8th week
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
Time Frame: 8th week
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
Tragus-C7-Shoulder Angle on lateral photography of head posture
Time Frame: 8th week
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
Time Frame: 8th week
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.
Disability based on Craniomandibular Pain and Disability Inventory
Time Frame: 8th week
Craniomandibular Pain and Disability Inventory. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
Disability based on Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire
Time Frame: 8th week
Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.
Pain intensity at last seven days based on Short-Form McGill Pain Questionnaire
Time Frame: 8th week
Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
Present pain intensity (ordinal)
Time Frame: 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.
Chronic pain intensity
Time Frame: 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 pain intensity
Time Frame: 8th week
Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome.
Pain intensity at last seven days based on Numeric Pain Rating Scale
Time Frame: 8th week
Numeric Pain Rating Scale. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.
Temporomandibular disorder severity
Time Frame: 8th week
Fonseca Anamnestic Index. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.
Secondary Outcomes
- Temporomandibular joint range of motions(8th week)
- Function(8th week)