Clinical trial NCT06627855: Effectiveness of the Fascial Distortion Model in Temporomandibular Disorders: A Randomized Sham-controlled Trial
Official title: Investigation of the Effectiveness of Manual Therapy Based on Fascial Distortion Model in Individuals With Temporomandibular Disorder: A Randomized Sham-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Temporomandibular Disorders (TMD)
Manual Therapy
Fascial Distortion
Keywords: manual therapy
fascial distortion model
temporomandibular disorders
head posture
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Radiotherapy in the head and neck region
* Pregnancy or breastfeeding
* Exercise therapy for craniocervical posture for the last month

Primary outcomes:
measure: Head posture
timeFrame: From enrollment to the end of treatment at 4th week
measure: Cervical range of motions
timeFrame: From enrollment to the end of treatment at 4th week
measure: Temporomandibular range of motions
timeFrame: From enrollment to the end of treatment at 4th week
measure: Cervical muscle performance
timeFrame: From enrollment to the end of treatment at 4th week
measure: Pressure pain threshold
timeFrame: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.
measure: Pain intensity in the last week
timeFrame: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.
measure: Chronic pain intensity
timeFrame: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.
measure: Temporomandibular disorders severity
timeFrame: From enrollment to the end of treatment at 4th week
measure: Dysfunction
timeFrame: From enrollment to the end of treatment at 4th week
measure: Disability
timeFrame: From enrollment to the end of treatment at 4th week
measure: Health-related quality of life
timeFrame: From enrollment to the end of treatment at 4th week
measure: Kinesiophobia
timeFrame: From enrollment to the end of treatment at 4th week
measure: Central sensitization
timeFrame: From enrollment to the end of treatment at 4th week
measure: Present pain intensity
timeFrame: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.
measure: Present pain intensity (ordinal)
timeFrame: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.
measure: Pain intensity in the last week (ordinal)
timeFrame: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.
Secondary outcomes:
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Karabük University
state: Karabük
Study officials:
affiliation: Karabük University
name: Harun Gençosmanoğlu, PT, MSc
role: PRINCIPAL_INVESTIGATOR
References: