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

NCT06134310 | Completed

• 2 other identifiers: 000027554681649B032002402
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

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.

Conditions

Temporomandibular Disorder; Temporomandibular Joint Dysfunction Syndrome; Temporomandibular Joint Disorders; Temporomandibular Joint Pain; Temporomandibular Joint Disc Displacement; Manual Therapy

Keywords

Fascial Distortion Model; Core Stabilization Training

Outcome Measures

Primary Outcomes (41)

• 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 Outcomes (4)

• Function

  Baseline

• Function

  8th week

• Temporomandibular joint range of motions

  Baseline

• Temporomandibular joint range of motions

  8th week

Study Arms (3)

Manual Therapy based Fascial Distortion Model

ACTIVE COMPARATOR

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; Procedure: Rocabado's 6x6 Exercises; Behavioral: Patient Education

Core Stabilization Training

ACTIVE COMPARATOR

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; Procedure: Rocabado's 6x6 Exercises; Behavioral: Patient Education

Control

NO INTERVENTION

No participant was given any therapy during the study.

Interventions

Fascial Distortion Model PROCEDURE

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.

Manual Therapy based Fascial Distortion Model

Core Stabilization Training PROCEDURE

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

Also known as: Spinal Stabilization Training

Core Stabilization Training

Rocabado's 6x6 Exercises PROCEDURE

Resting position of the tongue, rotational control of temporomandibular joint, rhythmic stabilization, axial extension of the neck, shoulder posture, and stabilized head flexion

Core Stabilization Training; Manual Therapy based Fascial Distortion Model

Patient Education BEHAVIORAL

Participants are instructed to perform some behaviors while avoiding others based on the etiology of temporomandibular disorders.

Core Stabilization Training; Manual Therapy based Fascial Distortion Model

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (2)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

University of Karabük

Karabük, 78050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Myofascial Pain Syndromes

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Harun Gençosmanoğlu, PT, MSc

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 18, 2023
• Study Start: November 7, 2023
• Primary Completion: February 28, 2024
• Study Completion: July 15, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)