Effectiveness of the Fascial Distortion Model on the Cervical Spine in Individuals With Temporomandibular Disorder

NCT ID: NCT06186817

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-17

Study Completion Date

2025-01-02

Brief Summary

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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

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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).

Conditions

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Temporomandibular Disorder Temporomandibular Disorders Temporomandibular Joint Disorders Temporomandibular Joint Dysfunction Syndrome Temporomandibular Joint Dysfunction Manual Therapy Core Stabilization Exercise Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Manual Therapy based Fascial Distortion Model

All participants were given manual therapy based on the Fascial Distortion Model in addition to conventional therapy (Rocabado's 6x6 Exercises and Patient Education). Conventional therapy was implemented as a home program for 8 weeks, while Manual Therapy was conducted for forty-five minutes once a week in a clinical setting.

Group Type ACTIVE_COMPARATOR

Fascial Distortion Model

Intervention Type PROCEDURE

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.

Rocabado's 6x6 Exercises

Intervention Type PROCEDURE

Resting position of the tongue, rotational control of temporomandibular joint, rhythmic stabilization, axial extension of the neck, shoulder posture, and stabilized head flexion

Patient Education

Intervention Type BEHAVIORAL

Participants are instructed to perform some behaviors while avoiding others based on the etiology of temporomandibular disorders.

Core Stabilization Training

All participants were given manual therapy based on the Core Stabilization Training in addition to conventional therapy (Rocabado's 6x6 Exercises and Patient Education). Conventional therapy was implemented as a home program for 8 weeks, while Core Stabilization Training was conducted for forty-five minutes once a week in a clinical setting.

Group Type ACTIVE_COMPARATOR

Rocabado's 6x6 Exercises

Intervention Type PROCEDURE

Resting position of the tongue, rotational control of temporomandibular joint, rhythmic stabilization, axial extension of the neck, shoulder posture, and stabilized head flexion

Patient Education

Intervention Type BEHAVIORAL

Participants are instructed to perform some behaviors while avoiding others based on the etiology of temporomandibular disorders.

Core Stabilization Training

Intervention Type PROCEDURE

Week 1st (1 x 10 reps): Supine deep cervical activation, supine deep lumbar activation, prone deep cervical activation, prone deep lumbar activation, supine combined deep cervical and lumbar activation, and prone combined deep cervical and lumbar activation; Week 2nd (1 x 10 reps): Arm openings, hundreds 1, one leg stretch 1, double leg stretch 1, shoulder bridge, breaststroke, leg pull prone prep 1; Week 3rd (1 x 10 reps): Arm openings, hundreds 2, one leg stretch 2, double leg stretch 2, shoulder bridge, breaststroke, leg pull prone prep 2; Week 4th (1 x 10 reps): Arm openings, hundreds 2, one leg stretch 2, double leg stretch 3, shoulder bridge, breaststroke, leg pull prone prep 2; Week 5th to 8th (with Resistance Band; 1 x 10 reps): Arm openings, shoulder bridge, swan dive, scapula isolations, plough, biceps curl, roll up, roll up with biceps, roll up with rowing, seated spine twist, swimming in kneeling, one leg kick in kneeling and diamond press in standing

Control

No participant was given any therapy during the study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Rocabado's 6x6 Exercises

Resting position of the tongue, rotational control of temporomandibular joint, rhythmic stabilization, axial extension of the neck, shoulder posture, and stabilized head flexion

Intervention Type PROCEDURE

Patient Education

Participants are instructed to perform some behaviors while avoiding others based on the etiology of temporomandibular disorders.

Intervention Type BEHAVIORAL

Core Stabilization Training

Week 1st (1 x 10 reps): Supine deep cervical activation, supine deep lumbar activation, prone deep cervical activation, prone deep lumbar activation, supine combined deep cervical and lumbar activation, and prone combined deep cervical and lumbar activation; Week 2nd (1 x 10 reps): Arm openings, hundreds 1, one leg stretch 1, double leg stretch 1, shoulder bridge, breaststroke, leg pull prone prep 1; Week 3rd (1 x 10 reps): Arm openings, hundreds 2, one leg stretch 2, double leg stretch 2, shoulder bridge, breaststroke, leg pull prone prep 2; Week 4th (1 x 10 reps): Arm openings, hundreds 2, one leg stretch 2, double leg stretch 3, shoulder bridge, breaststroke, leg pull prone prep 2; Week 5th to 8th (with Resistance Band; 1 x 10 reps): Arm openings, shoulder bridge, swan dive, scapula isolations, plough, biceps curl, roll up, roll up with biceps, roll up with rowing, seated spine twist, swimming in kneeling, one leg kick in kneeling and diamond press in standing

Intervention Type PROCEDURE

Other Intervention Names

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Spinal Stabilization Training

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karabuk University

OTHER

Sponsor Role collaborator

Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Harun Gençosmanoğlu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Harun Gençosmanoğlu, PT, MSc

Role: PRINCIPAL_INVESTIGATOR

Karabük University

Locations

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Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status

Karabük University

Karabük, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2023/1359

Identifier Type: -

Identifier Source: org_study_id

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