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NCT Number: NCT06134310

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

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.

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Key information

Conditions

Temporomandibular Disorder Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Manual Therapy Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Stomatognathic Diseases Temporomandibular Joint Disc Displacement Temporomandibular Joint Disorders Temporomandibular Joint Dysfunction Syndrome Temporomandibular Joint Pain

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University, Ankara, Turkey (Türkiye)

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Other names: Spinal 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

Patient education

Behavioral

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

Primary outcomes

  1. Eye-Tragus-Horizontal Angle on lateral photography of head posture

    Time frame: Baseline

    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

  2. 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

  3. Pogonion-Tragus-C7 Angle on lateral photography of head posture

    Time frame: Baseline

    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

  4. 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

  5. Tragus-C7-Horizontal Angle on lateral photography of head posture

    Time frame: Baseline

    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

  6. 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

  7. Tragus-C7-Shoulder Angle on lateral photography of head posture

    Time frame: Baseline

    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.

  8. 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.

  9. Shoulder-C7-Horizontal Angle on lateral photography of head posture

    Time frame: Baseline

    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.

  10. 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.

  11. Disability based on Craniomandibular Pain and Disability Inventory

    Time frame: Baseline

    Craniomandibular Pain and Disability Inventory. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.

  12. 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.

  13. Disability based on Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire

    Time frame: Baseline

    Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.

  14. 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.

  15. Chronic pain intensity

    Time frame: Baseline

    Graded Chronic Pain Scale (Revised). Scoring: Grade 1=mild, Grade 2=bothersome, Grade 3=high impact chronic pain. Higher scores mean a worse outcome.

  16. Chronic pain intensity

    Time frame: 2nd 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.

  17. Chronic pain intensity

    Time frame: 4th 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.

  18. Chronic pain intensity

    Time frame: 6th 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.

  19. 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.

  20. Pain intensity at last seven days based on Short-Form McGill Pain Questionnaire

    Time frame: Baseline

    Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.

  21. Pain intensity at last seven days based on Short-Form McGill Pain Questionnaire

    Time frame: 2nd week

    Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.

  22. Pain intensity at last seven days based on Short-Form McGill Pain Questionnaire

    Time frame: 4th week

    Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.

  23. Pain intensity at last seven days based on Short-Form McGill Pain Questionnaire

    Time frame: 6th week

    Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.

  24. 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.

  25. Present pain intensity

    Time frame: Baseline

    Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome.

  26. Present pain intensity

    Time frame: 2nd week

    Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome.

  27. Present pain intensity

    Time frame: 4th week

    Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome.

  28. Present pain intensity

    Time frame: 6th week

    Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome.

  29. 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.

  30. Present pain intensity (ordinal)

    Time frame: Baseline

    Present pain intensity scale of McGill Pain Questionnaire. Minimum and maximum values are 0 and 5 points, respectively. Higher scores mean a worse outcome.

  31. Present pain intensity (ordinal)

    Time frame: 2nd 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.

  32. Present pain intensity (ordinal)

    Time frame: 4th 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.

  33. Present pain intensity (ordinal)

    Time frame: 6th 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.

  34. 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.

  35. Pain intensity at last seven days based on Numeric Pain Rating Scale

    Time frame: Baseline

    Numeric Pain Rating Scale. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.

  36. Pain intensity at last seven days based on Numeric Pain Rating Scale

    Time frame: 2nd week

    Numeric Pain Rating Scale. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.

  37. Pain intensity at last seven days based on Numeric Pain Rating Scale

    Time frame: 4th week

    Numeric Pain Rating Scale. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.

  38. Pain intensity at last seven days based on Numeric Pain Rating Scale

    Time frame: 6th week

    Numeric Pain Rating Scale. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.

  39. 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.

  40. Temporomandibular disorder severity

    Time frame: Baseline

    Fonseca Anamnestic Index. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.

  41. 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

  1. Function

    Time frame: Baseline

    Mandibular Function Impairment Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.

  2. Function

    Time frame: 8th week

    Mandibular Function Impairment Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.

  3. Temporomandibular joint range of motions

    Time frame: Baseline

    Dijital caliper measurements

  4. Temporomandibular joint range of motions

    Time frame: 8th week

    Dijital caliper measurements

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2023
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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