Clinical trial NCT06134310: Efficacy of Manual Therapy Based on the Fascial Distortion Model in Individuals With Temporomandibular Disorder
Official title: Investigation of the Efficacy of Manual Therapy Based on the Fascial Distortion Model in Individuals With Temporomandibular Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorder
Temporomandibular Joint Dysfunction Syndrome
Temporomandibular Joint Disorders
Temporomandibular Joint Pain
Temporomandibular Joint Disc Displacement
Manual Therapy
Keywords: Fascial Distortion Model
Core Stabilization Training
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2023-11-18
Enrollment: 53
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 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Eye-Tragus-Horizontal Angle on lateral photography of head posture
timeFrame: Baseline
measure: Eye-Tragus-Horizontal Angle on lateral photography of head posture
timeFrame: 8th week
measure: Pogonion-Tragus-C7 Angle on lateral photography of head posture
timeFrame: Baseline
measure: Pogonion-Tragus-C7 Angle on lateral photography of head posture
timeFrame: 8th week
measure: Tragus-C7-Horizontal Angle on lateral photography of head posture
timeFrame: Baseline
measure: Tragus-C7-Horizontal Angle on lateral photography of head posture
timeFrame: 8th week
measure: Tragus-C7-Shoulder Angle on lateral photography of head posture
timeFrame: Baseline
measure: Tragus-C7-Shoulder Angle on lateral photography of head posture
timeFrame: 8th week
measure: Shoulder-C7-Horizontal Angle on lateral photography of head posture
timeFrame: Baseline
measure: Shoulder-C7-Horizontal Angle on lateral photography of head posture
timeFrame: 8th week
measure: Disability based on Craniomandibular Pain and Disability Inventory
timeFrame: Baseline
measure: Disability based on Craniomandibular Pain and Disability Inventory
timeFrame: 8th week
measure: Disability based on Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire
timeFrame: Baseline
measure: Disability based on Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire
timeFrame: 8th week
measure: Chronic pain intensity
timeFrame: Baseline
measure: Chronic pain intensity
timeFrame: 2nd week
measure: Chronic pain intensity
timeFrame: 4th week
measure: Chronic pain intensity
timeFrame: 6th week
measure: Chronic pain intensity
timeFrame: 8th week
measure: Pain intensity at last seven days based on Short-Form McGill Pain Questionnaire
timeFrame: Baseline
measure: Pain intensity at last seven days based on Short-Form McGill Pain Questionnaire
timeFrame: 2nd week
measure: Pain intensity at last seven days based on Short-Form McGill Pain Questionnaire
timeFrame: 4th week
measure: Pain intensity at last seven days based on Short-Form McGill Pain Questionnaire
timeFrame: 6th week
measure: Pain intensity at last seven days based on Short-Form McGill Pain Questionnaire
timeFrame: 8th week
measure: Present pain intensity
timeFrame: Baseline
measure: Present pain intensity
timeFrame: 2nd week
measure: Present pain intensity
timeFrame: 4th week
measure: Present pain intensity
timeFrame: 6th week
measure: Present pain intensity
timeFrame: 8th week
measure: Present pain intensity (ordinal)
timeFrame: Baseline
measure: Present pain intensity (ordinal)
timeFrame: 2nd week
measure: Present pain intensity (ordinal)
timeFrame: 4th week
measure: Present pain intensity (ordinal)
timeFrame: 6th week
measure: Present pain intensity (ordinal)
timeFrame: 8th week
measure: Pain intensity at last seven days based on Numeric Pain Rating Scale
timeFrame: Baseline
measure: Pain intensity at last seven days based on Numeric Pain Rating Scale
timeFrame: 2nd week
measure: Pain intensity at last seven days based on Numeric Pain Rating Scale
timeFrame: 4th week
measure: Pain intensity at last seven days based on Numeric Pain Rating Scale
timeFrame: 6th week
measure: Pain intensity at last seven days based on Numeric Pain Rating Scale
timeFrame: 8th week
measure: Temporomandibular disorder severity
timeFrame: Baseline
measure: Temporomandibular disorder severity
timeFrame: 8th week
Secondary outcomes:
measure: Function
timeFrame: Baseline
measure: Function
timeFrame: 8th week
measure: Temporomandibular joint range of motions
timeFrame: Baseline
measure: Temporomandibular joint range of motions
timeFrame: 8th week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
city: Karabük
country: Turkey
facility: University of Karabük
Study officials:
affiliation: Hacettepe University
name: Harun Gençosmanoğlu, PT, MSc
role: PRINCIPAL_INVESTIGATOR
References: