Clinical trial NCT06186817: Effectiveness of the Fascial Distortion Model on the Cervical Spine in Individuals With Temporomandibular Disorder
Official title: Effectiveness of Manual Therapy Based on the Fascial Distortion Model on the Cervical Spine in Individuals With Temporomandibular Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorder
Temporomandibular Disorders
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Temporomandibular Joint Dysfunction
Manual Therapy
Core Stabilization Exercise Therapy
Keywords: Temporomandibular Disorders
Fascial Distortion Model
Core Stabilization Training
Head Posture
Neck Pain
Manual Therapy
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Karabuk University
First posted: 2024-01-02
Enrollment: 51
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 effectiveness of Manual Therapy Based on the Fascial Distortion Model (FDM) on the cervical spine 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 effectiveness of the addition of FDM-based Manual Therapy to conventional therapy different from the addition of CST or control? Is the effectiveness 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.

Neck pain intensity, hand grip strength, head posture, cervical muscle performance, cervical range of motion (function), disability, and quality of life will be assessed.

Detailed description: Interventions are needed to address neck pain intensity, hand grip strength, head posture, cervical muscle performance, cervical range of motion (function), disability, and quality of life in individuals with temporomandibular disorder (TMD). This study aims to examine the effectiveness 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. Neck pain intensity will be assessed using the Graded Chronic Pain Scale (Revised) and the Short-Form McGill Pain Questionnaire. Hand grip strength and head posture will be assessed using a hand dynamometer and lateral photography, respectively. The Functional Strength Testing of the Cervical Spine and cervical range of motions will be used to assess cervical muscle performance and function, respectively. Disability and quality of life will be evaluated using the Neck Disability Index and the Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire. All outcomes will be measured at baseline and end of the study, while neck 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 regions 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: From enrollment to the end of treatment at 8 weeks
measure: Pogonion-Tragus-C7 Angle on lateral photography of head posture
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Tragus-C7-Horizontal Angle on lateral photography of head posture
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Tragus-C7-Shoulder Angle on lateral photography of head posture
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Shoulder-C7-Horizontal Angle on lateral photography of head posture
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Disability based on Neck Disability Index
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Quality of Life based on Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Chronic neck pain intensity
timeFrame: Baseline, 2nd week, 4th week, 6th week and 8th week
measure: Neck pain intensity at last seven days based on Short-Form McGill Pain Questionnaire
timeFrame: Baseline, 2nd week, 4th week, 6th week and 8th week
measure: Present neck pain intensity
timeFrame: Baseline, 2nd week, 4th week, 6th week and 8th week
measure: Present neck pain intensity (ordinal)
timeFrame: Baseline, 2nd week, 4th week, 6th week and 8th week
measure: Neck pain intensity at last seven days based on Numeric Pain Rating Scale
timeFrame: Baseline, 2nd week, 4th week, 6th week and 8th week
measure: Cervical active range of motion
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: Hand grip strength
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Cervical muscle performance
timeFrame: From enrollment to the end of treatment at 8 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
city: Karabük
country: Turkey
facility: Karabük University
Study officials:
affiliation: Karabük University
name: Harun Gençosmanoğlu, PT, MSc
role: PRINCIPAL_INVESTIGATOR
References: