Effectiveness of the Fascial Distortion Model in Temporomandibular Disorders: A Randomized Sham-controlled Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Sham treatment: 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Head posture — From enrollment to the end of treatment at 4th week
  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.
• Cervical range of motions — From enrollment to the end of treatment at 4th week
  Inclinometric measurements based on flexion, extension, lateral flexions, and rotations.
• Temporomandibular range of motions — From enrollment to the end of treatment at 4th week
  Digital vernier caliper measurements based on maximum pain-free mouth opening, maximum possible mouth opening, maximum possible assisted mouth opening, laterotrusions, and protrusion.
• Cervical muscle performance — From enrollment to the end of treatment at 4th week
  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.
• Pressure pain threshold — From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.
  Algometer. Tempormandibular joint, masseter, temporalis anterior, suboccipital muscle, trapezius, lateral epicondyle for both side.
• Pain intensity in the last week — From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.
  Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
• Chronic pain intensity — From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 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.
• Temporomandibular disorders severity — From enrollment to the end of treatment at 4th week
  Fonseca Anamnestic Index. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.
• Dysfunction — From enrollment to the end of treatment at 4th week
  Mandibular Function Impairment Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.
• Disability — From enrollment to the end of treatment at 4th week
  Craniofacial Pain and Disability Inventory. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
• Health-related quality of life — From enrollment to the end of treatment at 4th week
  Short Form-36. Its subdomains are physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health.
• Kinesiophobia — From enrollment to the end of treatment at 4th week
  Tampa Kinesiophobia Scale for Temporomandibular Disorders. Minimum and maximum values are 1 and 4 points, respectively. Higher scores mean a worse outcome.
• Central sensitization — From enrollment to the end of treatment at 4th week
  Central Sensitisation Inventory. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.
• Present pain intensity — From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.
  Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome.
• Present pain intensity (ordinal) — From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 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.
• Pain intensity in the last week (ordinal) — From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.
  Numeric Pain Rating Scale. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.

Trial sites (1)

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