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The aim of the study was to investigate the effectiveness of Manual Therapy Based on the Fascial Distortion Model in individuals with temporomandibular disorders compared to sham control. Individuals diagnosed with temporomandibular disorder will be randomly assigned to groups as Group 1 (Manual Therapy Based on Fascial Distortion Model) and Group 2 (Sham Control). Head posture, cervical and temporomandibular joint range of motion, cervical muscle performance, pain intensity, pressure pain thresholds, temporomandibular disorder severity, disability, dysfunction, health-related quality of life, kinesiophobia, and central sensitization will be assessed.
Interventions are needed to address head posture, cervical and temporomandibular joint range of motion, cervical muscle performance, pain intensity, pressure pain thresholds, temporomandibular disorder severity, disability, dysfunction, health-related quality of life, kinesiophobia, and central sensitization in individuals with temporomandibular disorder (TMD). This study aims to examine the effectiveness of Manual Therapy Based on the Fascial Distortion Model in individuals with TMDs compared to sham control over a 4-week period. Individuals with TMD will be randomized into Group 1 (Fascial Distortion Model-based Manual Therapy) or Group 2 (Sham Control). Interventions will be conducted once a week in a clinical setting. Head posture will be measured by lateral photogrammetry, cervical range of motion will be measured by an inclinometer, temporomandibular range of motion will be measured by a vernier caliper, cervical muscle performance will be measured by Cervical Spine Functional Strength Test, and pressure pain threshold will be measured by an algometer. Pain intensity will be assessed using the Graded Chronic Pain Scale (Revised) and the Short-Form McGill Pain Questionnaire. TMD severity will be assessed using the Fonseca Anamnestic Index. Mandibular Function Impairment Questionnaire will be used to assess dysfunction. Disability will be evaluated using the Craniofacial Pain and Disability Inventory. Health-related quality of life will be assessed using Short Form-36. Kinesiophobia will be assessed with the Tampa Kinesiophobia Scale; central sensitization will be assessed with the Central Sensitisation Inventory.
All outcomes will be measured at baseline and end of the study, while pain intensity and pressure pain thresholds will also undergo intermediate assessments (2nd and 3rd week).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual Therapy based Fascial Distortion Model | Active Comparator | It will conducted for forty-five minutes once a week in a clinical setting for 4 weeks. |
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| Control | Sham Comparator | Sham application will conducted for forty-five minutes once a week in a clinical setting for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Head posture | Lateral photogrammetry according to Eye-Tragus-Horizontal Angle, Pogonion-Tragus-C7 Angle, Tragus-C7-Horizontal Angle, Tragus-C7-Shoulder Angle, and Shoulder-C7-Horizontal Angle. | From enrollment to the end of treatment at 4th week |
| Cervical range of motions | Inclinometric measurements based on flexion, extension, lateral flexions, and rotations. | From enrollment to the end of treatment at 4th week |
| Temporomandibular range of motions | Digital vernier caliper measurements based on maximum pain-free mouth opening, maximum possible mouth opening, maximum possible assisted mouth opening, laterotrusions, and protrusion. | From enrollment to the end of treatment at 4th week |
| Cervical muscle performance | The Functional Strength Testing of the Cervical Spine was used to evaluate the cervical muscle performance. This is a test that functionally evaluates cervical muscle strength. Results of this test are assessed as functional, functionally fair, functionally poor, and nonfunctional. Six-to-eight repetitions for the flexion test and 20-25 s holding time for the other tests indicate that the test result is functional. Three-to-five repetitions for the flexion test and 10-19 s holding time for the other tests indicate that the test result is functionally fair. One-to-two repetitions for the flexion test and 1-9 s holding time for the other tests indicate that the test result is functionally poor. Zero repetition for the flexion test and 0 s holding time for the other tests indicate that the test result is nonfunctional. Each test was terminated at onset of pain, and the relevant value was recorded. | From enrollment to the end of treatment at 4th week |
| Pressure pain threshold | Algometer. Tempormandibular joint, masseter, temporalis anterior, suboccipital muscle, trapezius, lateral epicondyle for both side. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Harun Gençosmanoğlu, PT, MSc | Contact | +903704189093 | harungencosmanoglu@karabuk.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Harun Gençosmanoğlu, PT, MSc | Karabük University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karabük University | Recruiting | Merkez | Karabük Province | 78050 | Turkey (Türkiye) |
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| Sham treatment | Procedure | The techniques in the therapy will be applied by imitating the techniques in the therapy for the fascial distortions determined according to the Manual Therapy Based on the Fascial Distortion Model. |
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| From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week. |
| Pain intensity in the last week | Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome. | From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 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. | From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week. |
| Temporomandibular disorders severity | Fonseca Anamnestic Index. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome. | From enrollment to the end of treatment at 4th week |
| Dysfunction | Mandibular Function Impairment Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome. | From enrollment to the end of treatment at 4th week |
| Disability | Craniofacial Pain and Disability Inventory. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome. | From enrollment to the end of treatment at 4th week |
| Health-related quality of life | Short Form-36. Its subdomains are physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. | From enrollment to the end of treatment at 4th week |
| Kinesiophobia | Tampa Kinesiophobia Scale for Temporomandibular Disorders. Minimum and maximum values are 1 and 4 points, respectively. Higher scores mean a worse outcome. | From enrollment to the end of treatment at 4th week |
| Central sensitization | Central Sensitisation Inventory. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome. | From enrollment to the end of treatment at 4th week |
| Present pain intensity | Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome. | From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 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. | From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week. |
| Pain intensity in the last week (ordinal) | Numeric Pain Rating Scale. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome. | From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week. |
| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
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