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

Temporomandibular Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06134310
• Other study ID #: 00002755468
• Secondary ID: 1649B032002402
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2023
• Est. completion date: March 2024

Study information

• Verified date: November 2023
• Source: Hacettepe University
• Contact: Harun Gençosmanoglu, PT, MSc
• Phone: +903704189093
• Email: harun.gencosmanoglu[@]hacettepe.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: March 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Joint Diseases
• Manual Therapy
• Temporomandibular Disorder
• Temporomandibular Joint Disc Displacement
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome
• Temporomandibular Joint Pain

Intervention

Procedure:
• Fascial Distortion Model
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.
• Core Stabilization Training
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
• Rocabado's 6x6 Exercises
Resting position of the tongue, rotational control of temporomandibular joint, rhythmic stabilization, axial extension of the neck, shoulder posture, and stabilized head flexion

Behavioral:
• Patient Education
Participants are instructed to perform some behaviors while avoiding others based on the etiology of temporomandibular disorders.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara
Turkey	University of Karabük	Karabük

Sponsors (2)

Lead Sponsor	Collaborator
Hacettepe University	The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Present pain intensity	Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome.	Baseline
Primary	Present pain intensity	Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome.	2nd week
Primary	Present pain intensity	Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome.	4th week
Primary	Present pain intensity	Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome.	6th week
Primary	Present pain intensity	Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome.	8th week
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Temporomandibular disorder severity	Fonseca Anamnestic Index. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.	Baseline
Primary	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	Function	Mandibular Function Impairment Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.	Baseline
Secondary	Function	Mandibular Function Impairment Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.	8th week
Secondary	Temporomandibular joint range of motions	Dijital caliper measurements	Baseline
Secondary	Temporomandibular joint range of motions	Dijital caliper measurements	8th week