Efficacy of Manual Therapy Based on the Fascial Distortion Model in Individuals With Temporomandibular Disorder
- Conditions
- Temporomandibular Joint Dysfunction SyndromeTemporomandibular Joint Disc DisplacementManual TherapyTemporomandibular DisorderTemporomandibular Joint DisordersTemporomandibular Joint Pain
- Interventions
- Procedure: Fascial Distortion ModelProcedure: Core Stabilization TrainingProcedure: Rocabado's 6x6 ExercisesBehavioral: Patient Education
- Registration Number
- NCT06134310
- Lead Sponsor
- Hacettepe University
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 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 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. 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. 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.
- Primary Outcome Measures
Name Time Method Eye-Tragus-Horizontal Angle on lateral photography of head posture 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 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 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 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 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 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 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 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) 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 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 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 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 8th week Fonseca Anamnestic Index. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.
- Secondary Outcome Measures
Name Time Method Temporomandibular joint range of motions 8th week Dijital caliper measurements
Function 8th week Mandibular Function Impairment Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.
Trial Locations
- Locations (2)
University of KarabĆ¼k
š¹š·KarabĆ¼k, Turkey
Hacettepe University
š¹š·Ankara, Turkey