Temporomandibular DisorderNCT06134310
Efficacy of Manual Therapy Based on the Fascial Distortion Model in Individuals With Temporomandibular Disorder
A study testing Fascial Distortion Model, Core Stabilization Training and Rocabado's 6x6 Exercises in people with Temporomandibular Disorder and Temporomandibular Joint Dysfunction Syndrome, run by Hacettepe University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Temporomandibular Disorder, Temporomandibular Joint Dysfunction Syndrome, Temporomandibular Joint Disorders
- What is being tested?
- Fascial Distortion Model, Core Stabilization Training and Rocabado's 6x6 Exercises
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 7 Nov 2023to 15 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Hacettepe University
Ankara, 06100
University of Karabük
Karabük, 78050
About this study
Official title: Investigation of the Efficacy of Manual Therapy Based on the Fascial Distortion Model in Individuals With Temporomandibular Disorder
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?
Read more
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.
Read the 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).
- Conditions
- Temporomandibular Disorder, Temporomandibular Joint Dysfunction Syndrome, Temporomandibular Joint Disorders, Temporomandibular Joint Pain, Temporomandibular Joint Disc Displacement, Manual Therapy
- Being tested
- Fascial Distortion Model, Core Stabilization Training, Rocabado's 6x6 Exercises, Patient Education
- Keywords
- Fascial Distortion Model, Core Stabilization Training
- Medical subject headings
- Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascial Distortion ModelProcedure or surgery
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.
Core Stabilization TrainingProcedure or surgery
Also called Spinal 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
Rocabado's 6x6 ExercisesProcedure or surgery
Resting position of the tongue, rotational control of temporomandibular joint, rhythmic stabilization, axial extension of the neck, shoulder posture, and stabilized head flexion
Patient EducationBehavioural
Participants are instructed to perform some behaviors while avoiding others based on the etiology of temporomandibular disorders.
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy based Fascial Distortion Model | Active comparator | 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. Receives: Procedure: Fascial Distortion Model; Procedure: Rocabado's 6x6 Exercises; Behavioral: Patient Education |
| Core Stabilization Training | Active comparator | 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. Receives: Procedure: Core Stabilization Training; Procedure: Rocabado's 6x6 Exercises; Behavioral: Patient Education |
| Control | No intervention | No participant was given any therapy during the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye-Tragus-Horizontal Angle on lateral photography of head posture
The angle between the line connecting the midpoint of the lateral corner of the eye to the tragus of ear and the horizontal line emerging from the tragus level. It refers to the cranial rotation angle
Measured: Baseline
Eye-Tragus-Horizontal Angle on lateral photography of head posture
The angle between the line connecting the midpoint of the lateral corner of the eye to the tragus of ear and the horizontal line emerging from the tragus level. It refers to the cranial rotation angle
Measured: 8th week
Pogonion-Tragus-C7 Angle on lateral photography of head posture
The angle between the line connecting the pogonion (the most protruding point on the front of the mandible) to the tragus and the line connecting the tragus to the C7 vertebra
Measured: Baseline
Pogonion-Tragus-C7 Angle on lateral photography of head posture
The angle between the line connecting the pogonion (the most protruding point on the front of the mandible) to the tragus and the line connecting the tragus to the C7 vertebra
Measured: 8th week
Tragus-C7-Horizontal Angle on lateral photography of head posture
The angle between the line connecting the tragus to the C7 vertebra and the horizontal line emerging from the C7 vertebra level. It refers to the neck inclination angle
Measured: Baseline
Tragus-C7-Horizontal Angle on lateral photography of head posture
The angle between the line connecting the tragus to the C7 vertebra and the horizontal line emerging from the C7 vertebra level. It refers to the neck inclination angle
Measured: 8th week
Tragus-C7-Shoulder Angle on lateral photography of head posture
The angle between the line connecting the acromion to the C7 vertebra and the line connecting the C7 vertebra to the tragus. It refers to the sum of the tragus-C7-horizontal angle and the shoulder-C7-horizontal angle; Shoulder-C7-Horizontal Angle (5): The angle between the line connecting the acromion to the C7 vertebra and the horizontal line emerging from the C7 vertebra level. It refers to the angle of the shoulder.
Measured: Baseline
Tragus-C7-Shoulder Angle on lateral photography of head posture
The angle between the line connecting the acromion to the C7 vertebra and the line connecting the C7 vertebra to the tragus. It refers to the sum of the tragus-C7-horizontal angle and the shoulder-C7-horizontal angle; Shoulder-C7-Horizontal Angle (5): The angle between the line connecting the acromion to the C7 vertebra and the horizontal line emerging from the C7 vertebra level. It refers to the angle of the shoulder.
Measured: 8th week
Shoulder-C7-Horizontal Angle on lateral photography of head posture
The angle between the line connecting the acromion to the C7 vertebra and the horizontal line emerging from the C7 vertebra level. It refers to the angle of the shoulder.
Measured: Baseline
Shoulder-C7-Horizontal Angle on lateral photography of head posture
The angle between the line connecting the acromion to the C7 vertebra and the horizontal line emerging from the C7 vertebra level. It refers to the angle of the shoulder.
Measured: 8th week
Disability based on Craniomandibular Pain and Disability Inventory
Craniomandibular Pain and Disability Inventory. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
Measured: Baseline
Disability based on Craniomandibular Pain and Disability Inventory
Craniomandibular Pain and Disability Inventory. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
Measured: 8th week
Disability based on Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire
Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.
Measured: Baseline
Disability based on Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire
Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.
Measured: 8th week
Chronic pain intensity
Graded Chronic Pain Scale (Revised). Scoring: Grade 1=mild, Grade 2=bothersome, Grade 3=high impact chronic pain. Higher scores mean a worse outcome.
Measured: Baseline
Chronic pain intensity
Graded Chronic Pain Scale (Revised). Scoring: Grade 1=mild, Grade 2=bothersome, Grade 3=high impact chronic pain. Higher scores mean a worse outcome.
Measured: 2nd week
Chronic pain intensity
Graded Chronic Pain Scale (Revised). Scoring: Grade 1=mild, Grade 2=bothersome, Grade 3=high impact chronic pain. Higher scores mean a worse outcome.
Measured: 4th week
Chronic pain intensity
Graded Chronic Pain Scale (Revised). Scoring: Grade 1=mild, Grade 2=bothersome, Grade 3=high impact chronic pain. Higher scores mean a worse outcome.
Measured: 6th week
Chronic pain intensity
Graded Chronic Pain Scale (Revised). Scoring: Grade 1=mild, Grade 2=bothersome, Grade 3=high impact chronic pain. Higher scores mean a worse outcome.
Measured: 8th week
Pain intensity at last seven days based on Short-Form McGill Pain Questionnaire
Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
Measured: Baseline
Pain intensity at last seven days based on Short-Form McGill Pain Questionnaire
Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
Measured: 2nd week
Pain intensity at last seven days based on Short-Form McGill Pain Questionnaire
Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
Measured: 4th week
Pain intensity at last seven days based on Short-Form McGill Pain Questionnaire
Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
Measured: 6th week
Pain intensity at last seven days based on Short-Form McGill Pain Questionnaire
Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
Measured: 8th week
Present pain intensity
Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome.
Measured: Baseline
Present pain intensity
Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome.
Measured: 2nd week
Present pain intensity
Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome.
Measured: 4th week
Present pain intensity
Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome.
Measured: 6th week
Present pain intensity
Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome.
Measured: 8th week
Present pain intensity (ordinal)
Present pain intensity scale of McGill Pain Questionnaire. Minimum and maximum values are 0 and 5 points, respectively. Higher scores mean a worse outcome.
Measured: Baseline
Present pain intensity (ordinal)
Present pain intensity scale of McGill Pain Questionnaire. Minimum and maximum values are 0 and 5 points, respectively. Higher scores mean a worse outcome.
Measured: 2nd week
Present pain intensity (ordinal)
Present pain intensity scale of McGill Pain Questionnaire. Minimum and maximum values are 0 and 5 points, respectively. Higher scores mean a worse outcome.
Measured: 4th week
Present pain intensity (ordinal)
Present pain intensity scale of McGill Pain Questionnaire. Minimum and maximum values are 0 and 5 points, respectively. Higher scores mean a worse outcome.
Measured: 6th week
Present pain intensity (ordinal)
Present pain intensity scale of McGill Pain Questionnaire. Minimum and maximum values are 0 and 5 points, respectively. Higher scores mean a worse outcome.
Measured: 8th week
Pain intensity at last seven days based on Numeric Pain Rating Scale
Numeric Pain Rating Scale. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.
Measured: Baseline
Pain intensity at last seven days based on Numeric Pain Rating Scale
Numeric Pain Rating Scale. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.
Measured: 2nd week
Pain intensity at last seven days based on Numeric Pain Rating Scale
Numeric Pain Rating Scale. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.
Measured: 4th week
Pain intensity at last seven days based on Numeric Pain Rating Scale
Numeric Pain Rating Scale. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.
Measured: 6th week
Pain intensity at last seven days based on Numeric Pain Rating Scale
Numeric Pain Rating Scale. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.
Measured: 8th week
Temporomandibular disorder severity
Fonseca Anamnestic Index. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.
Measured: Baseline
Temporomandibular disorder severity
Fonseca Anamnestic Index. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.
Measured: 8th week
Secondary outcomes (4)
Function
Mandibular Function Impairment Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.
Measured: Baseline
Function
Mandibular Function Impairment Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.
Measured: 8th week
Temporomandibular joint range of motions
Dijital caliper measurements
Measured: Baseline
Temporomandibular joint range of motions
Dijital caliper measurements
Measured: 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start7 Nov 2023
- Primary completion28 Feb 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Harun Gençosmanoğlu, Hacettepe University
- Investigators
- Harun Gençosmanoğlu, PT, MSc, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134310
- Sponsor's protocol ID
- 00002755468
- Other IDs
- 1649B032002402
- Status last verified
- Jul 2024
- First submitted
- 6 Nov 2023
- Last updated
- 29 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gencosmanoglu H, Yilmaz E, Coskun G. Effects of manual therapy versus Pilates-based core stability training in patients with temporomandibular disorders: A randomized controlled multicenter pilot study. Cranio. 2026 Mar 1:1-22. doi: 10.1080/08869634.2026.2636088. Online ahead of print.
PubMed 41766289
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Efficacy of Manual Therapy Based on the Fascial Distortion Model in Individuals With Temporomandibular Disorder
- ClinicalTrials.gov ID
- NCT06134310
- Acronym / sponsor ID
- 00002755468
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy based Fascial Distortion Model | Active comparator | Procedure: Fascial Distortion Model, Procedure: Rocabado's 6x6 Exercises, Behavioral: Patient EducationAll 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. |
| Core Stabilization Training | Active comparator | Procedure: Core Stabilization Training, Procedure: Rocabado's 6x6 Exercises, Behavioral: Patient EducationAll 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. |
| Control | No intervention | –No participant was given any therapy during the study. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fascial Distortion ModelThe 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. | Procedure or surgery | Manual Therapy based Fascial Distortion Model |
| Core Stabilization TrainingAlso: Spinal Stabilization TrainingWeek 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 | Procedure or surgery | Core Stabilization Training |
| Rocabado's 6x6 ExercisesResting position of the tongue, rotational control of temporomandibular joint, rhythmic stabilization, axial extension of the neck, shoulder posture, and stabilized head flexion | Procedure or surgery | Core Stabilization Training, Manual Therapy based Fascial Distortion Model |
| Patient EducationParticipants are instructed to perform some behaviors while avoiding others based on the etiology of temporomandibular disorders. | Behavioural | Core Stabilization Training, Manual Therapy based Fascial Distortion Model |
Primary outcome
Eye-Tragus-Horizontal Angle on lateral photography of head posture
Time frame: Baseline
The angle between the line connecting the midpoint of the lateral corner of the eye to the tragus of ear and the horizontal line emerging from the tragus level. It refers to the cranial rotation angle
Eye-Tragus-Horizontal Angle on lateral photography of head posture
Time frame: 8th week
The angle between the line connecting the midpoint of the lateral corner of the eye to the tragus of ear and the horizontal line emerging from the tragus level. It refers to the cranial rotation angle
Pogonion-Tragus-C7 Angle on lateral photography of head posture
Time frame: Baseline
The angle between the line connecting the pogonion (the most protruding point on the front of the mandible) to the tragus and the line connecting the tragus to the C7 vertebra
Pogonion-Tragus-C7 Angle on lateral photography of head posture
Time frame: 8th week
The angle between the line connecting the pogonion (the most protruding point on the front of the mandible) to the tragus and the line connecting the tragus to the C7 vertebra
Tragus-C7-Horizontal Angle on lateral photography of head posture
Time frame: Baseline
The angle between the line connecting the tragus to the C7 vertebra and the horizontal line emerging from the C7 vertebra level. It refers to the neck inclination angle
Tragus-C7-Horizontal Angle on lateral photography of head posture
Time frame: 8th week
The angle between the line connecting the tragus to the C7 vertebra and the horizontal line emerging from the C7 vertebra level. It refers to the neck inclination angle
Tragus-C7-Shoulder Angle on lateral photography of head posture
Time frame: Baseline
The angle between the line connecting the acromion to the C7 vertebra and the line connecting the C7 vertebra to the tragus. It refers to the sum of the tragus-C7-horizontal angle and the shoulder-C7-horizontal angle; Shoulder-C7-Horizontal Angle (5): The angle between the line connecting the acromion to the C7 vertebra and the horizontal line emerging from the C7 vertebra level. It refers to the angle of the shoulder.
Tragus-C7-Shoulder Angle on lateral photography of head posture
Time frame: 8th week
The angle between the line connecting the acromion to the C7 vertebra and the line connecting the C7 vertebra to the tragus. It refers to the sum of the tragus-C7-horizontal angle and the shoulder-C7-horizontal angle; Shoulder-C7-Horizontal Angle (5): The angle between the line connecting the acromion to the C7 vertebra and the horizontal line emerging from the C7 vertebra level. It refers to the angle of the shoulder.
Shoulder-C7-Horizontal Angle on lateral photography of head posture
Time frame: Baseline
The angle between the line connecting the acromion to the C7 vertebra and the horizontal line emerging from the C7 vertebra level. It refers to the angle of the shoulder.
Shoulder-C7-Horizontal Angle on lateral photography of head posture
Time frame: 8th week
The angle between the line connecting the acromion to the C7 vertebra and the horizontal line emerging from the C7 vertebra level. It refers to the angle of the shoulder.
Disability based on Craniomandibular Pain and Disability Inventory
Time frame: Baseline
Craniomandibular Pain and Disability Inventory. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
Disability based on Craniomandibular Pain and Disability Inventory
Time frame: 8th week
Craniomandibular Pain and Disability Inventory. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
Disability based on Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire
Time frame: Baseline
Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.
Disability based on Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire
Time frame: 8th week
Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.
Chronic pain intensity
Time frame: Baseline
Graded Chronic Pain Scale (Revised). Scoring: Grade 1=mild, Grade 2=bothersome, Grade 3=high impact chronic pain. Higher scores mean a worse outcome.
Chronic pain intensity
Time frame: 2nd week
Graded Chronic Pain Scale (Revised). Scoring: Grade 1=mild, Grade 2=bothersome, Grade 3=high impact chronic pain. Higher scores mean a worse outcome.
Chronic pain intensity
Time frame: 4th week
Graded Chronic Pain Scale (Revised). Scoring: Grade 1=mild, Grade 2=bothersome, Grade 3=high impact chronic pain. Higher scores mean a worse outcome.
Chronic pain intensity
Time frame: 6th week
Graded Chronic Pain Scale (Revised). Scoring: Grade 1=mild, Grade 2=bothersome, Grade 3=high impact chronic pain. Higher scores mean a worse outcome.
Chronic pain intensity
Time frame: 8th week
Graded Chronic Pain Scale (Revised). Scoring: Grade 1=mild, Grade 2=bothersome, Grade 3=high impact chronic pain. Higher scores mean a worse outcome.
Pain intensity at last seven days based on Short-Form McGill Pain Questionnaire
Time frame: Baseline
Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
Pain intensity at last seven days based on Short-Form McGill Pain Questionnaire
Time frame: 2nd week
Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
Pain intensity at last seven days based on Short-Form McGill Pain Questionnaire
Time frame: 4th week
Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
Pain intensity at last seven days based on Short-Form McGill Pain Questionnaire
Time frame: 6th week
Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
Pain intensity at last seven days based on Short-Form McGill Pain Questionnaire
Time frame: 8th week
Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
Present pain intensity
Time frame: Baseline
Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome.
Present pain intensity
Time frame: 2nd week
Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome.
Present pain intensity
Time frame: 4th week
Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome.
Present pain intensity
Time frame: 6th week
Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome.
Present pain intensity
Time frame: 8th week
Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome.
Present pain intensity (ordinal)
Time frame: Baseline
Present pain intensity scale of McGill Pain Questionnaire. Minimum and maximum values are 0 and 5 points, respectively. Higher scores mean a worse outcome.
Present pain intensity (ordinal)
Time frame: 2nd week
Present pain intensity scale of McGill Pain Questionnaire. Minimum and maximum values are 0 and 5 points, respectively. Higher scores mean a worse outcome.
Present pain intensity (ordinal)
Time frame: 4th week
Present pain intensity scale of McGill Pain Questionnaire. Minimum and maximum values are 0 and 5 points, respectively. Higher scores mean a worse outcome.
Present pain intensity (ordinal)
Time frame: 6th week
Present pain intensity scale of McGill Pain Questionnaire. Minimum and maximum values are 0 and 5 points, respectively. Higher scores mean a worse outcome.
Present pain intensity (ordinal)
Time frame: 8th week
Present pain intensity scale of McGill Pain Questionnaire. Minimum and maximum values are 0 and 5 points, respectively. Higher scores mean a worse outcome.
Pain intensity at last seven days based on Numeric Pain Rating Scale
Time frame: Baseline
Numeric Pain Rating Scale. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.
Pain intensity at last seven days based on Numeric Pain Rating Scale
Time frame: 2nd week
Numeric Pain Rating Scale. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.
Pain intensity at last seven days based on Numeric Pain Rating Scale
Time frame: 4th week
Numeric Pain Rating Scale. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.
Pain intensity at last seven days based on Numeric Pain Rating Scale
Time frame: 6th week
Numeric Pain Rating Scale. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.
Pain intensity at last seven days based on Numeric Pain Rating Scale
Time frame: 8th week
Numeric Pain Rating Scale. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.
Temporomandibular disorder severity
Time frame: Baseline
Fonseca Anamnestic Index. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.
Temporomandibular disorder severity
Time frame: 8th week
Fonseca Anamnestic Index. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.
4 secondary outcomes
Function
Time frame: Baseline
Function
Time frame: 8th week
Temporomandibular joint range of motions
Time frame: Baseline
Temporomandibular joint range of motions
Time frame: 8th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Derived from this study: PubMed 41766289Gencosmanoglu H, Yilmaz E, Coskun G. Effects of manual therapy versus Pilates-based core stability training in patients with temporomandibular disorders: A randomized controlled multicenter pilot study. Cranio. 2026 Mar 1:1-22. doi: 10.1080/08869634.2026.2636088. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harun Gençosmanoğlu, PT, MSc principal investigator
Hacettepe University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fascial Distortion Model, Core Stabilization Training and Rocabado's 6x6 Exercises in people with Temporomandibular Disorder and Temporomandibular Joint Dysfunction Syndrome, run by Hacettepe University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eye-Tragus-Horizontal Angle on lateral photography of head posture (time frame: Baseline). The study lists 41 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06134310, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.