Effectiveness of the Fascial Distortion Model in Temporomandibular Disorders: A Randomized Sham-controlled Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorKarabuk University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Having temporomandibular joint complaints and being diagnosed with temporomandibular disorder according to the Diagnostic Criteria for Temporomandibular Disorders Axis I
Understand and be willing to answer assessment questions
A temporomandibular joint complaint for the last three months
Pain in the jaw, face or neck
Disqualifiers
Has a systemic disease (neurological, rheumatologic, oncologic, etc.) that may affect the temporomandibular joint, cervical spine and/or assessment
Any history of trauma that may have affected the cranio-cervico-facial region
Having undergone any surgical intervention in the cranio-cervico-facial region within the last six months
Receiving surgical treatment, medical treatment, splint therapy or physiotherapy for temporomandibular disorder in the last month
Trial design
Design model
Parallel
Treatments tested in this trial
Fascial Distortion Model
Procedure/SurgeryThe 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
Procedure/SurgeryThe 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Manual Therapy based Fascial Distortion ModelActive comparator 1 intervention
Group B: ControlSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to the end of treatment at 4th week2
Cervical range of motions
Inclinometric measurements based on flexion, extension, lateral flexions, and rotations.
Time frame
From enrollment to the end of treatment at 4th week3
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.
Time frame
From enrollment to the end of treatment at 4th week4
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.
Time frame
From enrollment to the end of treatment at 4th weekLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Karabük UniversityRecruiting78050, Merkez, Karabük ProvinceTurkey (Türkiye)
Sponsors and contacts
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Source ClinicalTrials.gov