Temporomandibular Disorders (TMDs)NCT07392671
Investigation of the Effects of Different Treatment Approaches in Jaw (Temporomandibular) Joint Disorders
A study testing Conventional Physiotherapy and Rehabilitation Program and Limbic-Oriented Manual Therapy in people with Temporomandibular Disorders (TMDs), run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Temporomandibular joint disorders (TMD) are common conditions that may cause jaw pain, limited jaw movement, and reduced quality of life. Individuals with TMD can also experience neck-related problems, balance impairments, emotional changes, and sleep disturbances. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Temporomandibular Disorders (TMDs)
- What is being tested?
- Conventional Physiotherapy and Rehabilitation Program and Limbic-Oriented Manual Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2023to 1 Feb 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18 and 60 years
- Diagnosed with temporomandibular joint dysfunction (TMD - disc displacement or degenerative joint disease) by an Oral and Maxillofacial Surgery specialist
- Clinical findings consistent with temporomandibular joint dysfunction
- Presence of symptoms and pain related to TMD for at least 6 months
- No history of acute trauma, infection, or neurological disease
- No limitation of joint range of motion in the angles assessed for joint position sense
Show all 10Show fewer
- No history of any treatment or physiotherapy for TMD within the last 6 months
- Not using occlusal splints, orthodontic appliances, and/or medications for pain
- Use of no more than one fixed prosthetic restoration (bridge or implant-supported crown) in a single region
- Voluntary participation and provision of written informed consent
Who cannot join
- History of jaw and/or cervical region surgery or trauma within the last 6 months
- Presence of rheumatological or psychiatric disorders
- History of fracture involving the temporomandibular joint, cervical, or upper thoracic region
- Presence of acute cervical disc pathology or other acute conditions affecting the cervical region
- Presence of skin infection or open wounds
- Presence of perceptual or communication disorders
Show all 10Show fewer
- Partial edentulism classified as Kennedy Class I, II, or III, or multiple missing teeth that impair masticatory function, except for single-tooth loss
- Presence of fixed prosthetic restorations for more than one missing tooth
- Use of removable partial or complete dentures
- Unwillingness to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Physical Therapy and Rehabilitation, Musculoskeletal Physiotherapy and Rehabilitation Unit
Ankara
About this study
Official title: Investigation of the Effects of Limbic System-Oriented Combined Manual Therapy on Pain, Joint Range of Motion, Muscle Strength, Joint Position Sense, Balance, Functional Status, Emotional State, Quality of Life, and Sleep Quality in Temporomandibular Joint Dysfunction
Temporomandibular joint disorders (TMD) are common conditions that may cause jaw pain, limited jaw movement, and reduced quality of life. Individuals with TMD can also experience neck-related problems, balance impairments, emotional changes, and sleep disturbances.
This interventional study aims to investigate the effects of a combined physiotherapy and rehabilitation program in individuals with temporomandibular joint dysfunction. The intervention consists of conventional manual therapy techniques applied to the temporomandibular joint and cervical region, combined with specific manual therapy techniques targeting the limbic system, along with therapeutic exercise applications.
The study will evaluate the effects of this combined treatment approach on pain, jaw range of motion, joint position sense, balance, emotional status, patient satisfaction, and quality of life and sleep in individuals with TMD.
Read the detailed description
Temporomandibular joint dysfunction is a complex condition that affects the masticatory system and is frequently associated with cervical musculoskeletal impairments, altered sensorimotor control, and psychosocial factors. In addition to local biomechanical dysfunctions, individuals with temporomandibular disorders may experience changes in pain processing, emotional regulation, balance, and overall quality of life. These factors highlight the need for a comprehensive rehabilitation approach that addresses both peripheral and central mechanisms.
Physiotherapy and rehabilitation interventions for temporomandibular joint dysfunction traditionally focus on the temporomandibular joint and cervical region using manual therapy techniques and therapeutic exercises. While these approaches are effective in improving physical impairments, emerging evidence suggests that central mechanisms, including the limbic system, may influence pain perception, emotional status, and functional outcomes in individuals with temporomandibular disorders.
This interventional study is designed to investigate the effects of a combined physiotherapy and rehabilitation approach that integrates conventional manual therapy techniques applied to the temporomandibular joint and cervical region with specific manual therapy techniques oriented toward the limbic system, along with therapeutic exercise applications. The combined approach aims to address musculoskeletal, sensorimotor, and emotional components of temporomandibular joint dysfunction within a holistic rehabilitation framework.
Participants diagnosed with temporomandibular joint dysfunction will undergo the intervention program and will be evaluated before and after the treatment period. The study focuses on changes in pain, jaw function, sensorimotor control, balance, emotional status, patient satisfaction, and quality of life and sleep, providing a multidimensional assessment of treatment effects.
By examining the outcomes of this combined intervention, the study seeks to enhance the understanding of integrative physiotherapy strategies in the management of temporomandibular joint dysfunction and to support the development of more comprehensive rehabilitation approaches that consider both physical and emotional aspects of the condition.
- Conditions
- Temporomandibular Disorders (TMDs)
- Being tested
- Conventional Physiotherapy and Rehabilitation Program, Limbic-Oriented Manual Therapy
- Keywords
- temporomandibular joint disorders, Physiotherapy, Manual therapy, Limbic system, Pain
- Medical subject headings
- Temporomandibular Joint Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Physiotherapy and Rehabilitation ProgramOther
The intervention is delivered over a 6-week period. Manual therapy techniques applied to the cervical region and temporomandibular joint, along with supervised jaw exercises, are administered twice per week. In addition, participants perform postural exercises as part of a home exercise program for 6 weeks, 5 days per week, three times per day, with 10 repetitions per exercise. All interventions are administered by a physiotherapist according to a standardized physiotherapy protocol.
Limbic-Oriented Manual TherapyOther
In addition to the conventional physiotherapy and rehabilitation program, limbic-oriented manual therapy techniques are applied over a 6-week period. Three limbic-oriented manual therapy techniques are administered during each session, with each technique applied for an average duration of approximately 3 minutes. These techniques are administered twice per week by a physiotherapist according to the study protocol. The limbic-oriented manual therapy is delivered alongside manual therapy to the cervical region and temporomandibular joint, supervised jaw exercises, and a structured home exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Manual Therapy + Exercise Program | Active comparator | Participants in this arm receive a conventional physiotherapy and rehabilitation program consisting of manual therapy applied to the temporomandibular joint and cervical region, supervised therapeutic exercises, and a structured home exercise program. No limbic-oriented manual therapy techniques are included in this arm. Receives: Other: Conventional Physiotherapy and Rehabilitation Program |
| Conventional Program + Limbic-Oriented Manual Therapy | Experimental | Participants in this arm receive the same conventional physiotherapy and rehabilitation program, including temporomandibular joint and cervical manual therapy, supervised therapeutic exercises, and a home exercise program, with the addition of limbic-oriented manual therapy techniques aimed at modulating central pain processing and emotional regulation. Receives: Other: Conventional Physiotherapy and Rehabilitation Program; Other: Limbic-Oriented Manual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity at Rest (Visual Analog Scale)
Pain intensity at rest is assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 to 10 cm.
A score of 0 indicates no pain and a score of 10 indicates the worst imaginable pain.
Higher scores represent greater pain intensity. The distance from the left end of the scale to the marked point is measured using a ruler and recorded in centimeters (cm).
Measured: Baseline and after 6 weeks
Pressure Pain Threshold (Algometry)
Pressure pain threshold is assessed using a handheld pressure algometer. Measurements are performed bilaterally at three anatomical sites: the temporomandibular joint region, masseter muscle, and temporalis muscles, and recorded in Newton (N).
At each site, three consecutive measurements are taken, and the mean value is calculated for analysis.
Higher values indicate greater pressure pain tolerance, whereas lower values indicate increased pain sensitivity.
Assessments are conducted at baseline and at the end of the treatment period.
Measured: Baseline and after 6 weeks
Cervical Joint Position Sense
Cervical joint position sense is assessed during flexion-extension, right and left rotation, and right and left lateral flexion movements using target angle tests and the head repositioning test. Flexion, extension, and rotation movements are assessed at mid-range positions (50% of the available range of motion) and at target angles of 10° and 30°. Lateral flexion movements are assessed at target angles of 10° and 20°, as well as at mid-range positions (50% of the available range of motion). During each test, the deviation from the target angle is recorded. The angular error is calculated as the absolute difference between the target angle and the angle achieved by the participant and recorded in degrees (°). Higher angular error values indicate poorer joint position sense, whereas lower values indicate better proprioceptive accuracy. Each test is performed three times with the participant's eyes closed, and the mean value of the three measurements is recorded for analysis.
Measured: Baseline and after 6 weeks
Temporomandibular Joint Range of Motion
Temporomandibular joint range of motion is assessed using a digital caliper. Pain-free maximum mouth opening, right and left lateral excursions, and mandibular protrusion movements are measured.
All measurements are recorded in millimeters (mm) for analysis. Higher values indicate greater mandibular mobility, whereas lower values indicate restricted temporomandibular joint range of motion.
Measured: Baseline and after 6 weeks
Cervical Joint Range of Motion
Cervical joint flexion, extension, bilateral lateral flexion, and rotation movements are evaluated using a cervical range of motion (CROM) device.
Measurements are recorded in degrees (°). Higher values indicate greater cervical mobility, whereas lower values indicate restricted cervical range of motion.
Measured: Baseline and after 6 weeks
Static Balance (Flamingo Balance Test)
Static balance is assessed using the Flamingo Balance Test. Participants are instructed to stand on a wooden balance beam and maintain balance on one lower extremity.
The test is performed on the participant's dominant extremity. Timing begins when the participant achieves single-leg stance, and the participant is asked to maintain balance for one minute without falling.
During the one-minute period, each attempt to regain balance after a loss of balance is counted.
The total number of balance attempts recorded during the test constitutes the participant's score.
Higher scores indicate poorer static balance performance, whereas lower scores indicate better balance control.
Measured: Baseline and after 6 weeks
Dynamic Balance (Y Balance Test)
Dynamic balance is assessed using the Y Balance Test. The test is performed in the anterior, posteromedial, and posterolateral directions.
Participants perform three trials in each direction, and the mean value of the three measurements is calculated for analysis.
Reach distances are recorded in centimeters (cm). Higher reach distances indicate better dynamic balance performance, whereas lower values indicate reduced balance ability.
Measured: Baseline and after 6 weeks
Pain Intensity During Chewing (Visual Analog Scale)
Pain intensity during chewing is assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 to 10 cm.
Pain is evaluated separately during chewing of hard and soft food. A score of 0 indicates no pain, and a score of 10 indicates the worst imaginable pain.
Higher scores represent greater pain intensity. The distance from the left end of the scale to the marked point is measured using a ruler and recorded in centimeters (cm).
Measured: Baseline and after 6 weeks
Pain Intensity During Biting (Visual Analog Scale)
Pain intensity during biting is assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 to 10 cm.
A score of 0 indicates no pain, and a score of 10 indicates the worst imaginable pain.
Higher scores represent greater pain intensity. The distance from the left end of the scale to the marked point is measured using a ruler and recorded in centimeters (cm).
Measured: Baseline and after 6 weeks
Pain Intensity During Night-Time (Visual Analog Scale)
Night-time pain intensity is assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 to 10 cm.
A score of 0 indicates no pain, and a score of 10 indicates the worst imaginable pain.
Higher scores represent greater pain intensity. The distance from the left end of the scale to the marked point is measured using a ruler and recorded in centimeters (cm).
Measured: Baseline and after 6 weeks
Pain Intensity During Yawning
Pain intensity during yawning is assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 to 10 cm.
A score of 0 indicates no pain, and a score of 10 indicates the worst imaginable pain.
Higher scores represent greater pain intensity. The distance from the left end of the scale to the marked point is measured using a ruler and recorded in centimeters (cm).
Measured: Baseline and after 6 weeks
Pain Intensity During Eating (Visual Analog Scale)
Pain intensity during eating is assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 to 10 cm.
A score of 0 indicates no pain, and a score of 10 indicates the worst imaginable pain.
Higher scores represent greater pain intensity. The distance from the left end of the scale to the marked point is measured using a ruler and recorded in centimeters (cm).
Measured: Baseline and after 6 weeks
Temporomandibular Joint Dysfunction Severity (Fonseca Anamnestic Questionnaire)
Temporomandibular joint functional status is assessed using the Turkish version of the Fonseca Anamnestic Questionnaire. The total score ranges from 0 to 100, with higher scores indicating greater severity of temporomandibular joint dysfunction.
Measured: Baseline and after 6 weeks
Mandibular Functional Impairment (Mandibular Function Impairment Questionnaire)
Mandibular functional status is assessed using the Turkish version of the Mandibular Function Impairment Questionnaire. The total score ranges from 0 to 68, with higher scores indicating greater functional impairment
Measured: Baseline and after 6 weeks
Secondary outcomes (9)
Chewing Quality (Visual Analog Scale)
Chewing quality is assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 to 10 cm.
A score of 0 indicates very poor chewing quality, and a score of 10 indicates excellent chewing quality.
Higher scores represent better chewing quality. The distance from the left end of the scale to the marked point is measured using a ruler and recorded in centimeters (cm).
Measured: Baseline and after 6 weeks
Patient Satisfaction With Treatment (Visual Analog Scale)
Patient satisfaction with the treatment is assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 to 10 cm.
A score of 0 indicates "not satisfied at all," and a score of 10 indicates "extremely satisfied." Higher scores represent greater treatment satisfaction. The distance from the left end of the scale to the marked point is measured using a ruler and recorded in centimeters (cm).
Measured: At the end of the treatment period (6 weeks)
Postural Assessment
Postural assessment is performed bilaterally using a measuring tape. Linear distances are measured between predefined anatomical landmarks and recorded in centimeters (cm). Measurements are obtained from both sides of the body for analysis.
Measured: Baseline and after 6 weeks
Deep Cervical Flexor Muscle Strength
Deep cervical flexor muscle strength is assessed using a Stabilizer Pressure Biofeedback unit.
The pressure generated by the participant during the test is recorded in millimeters of mercury (mmHg).
The assessment is performed under two conditions: without visual feedback and with visual feedback, during which the manometer is visible to the participant.
In both conditions, participants are instructed to perform a craniocervical flexion movement, and the corresponding pressure values are recorded for analysis.
Higher pressure values indicate greater deep cervical flexor muscle activation and strength.
Measured: Baseline and after 6 weeks
Neck Disability
Neck-related disability is assessed using the Turkish version of the Neck Disability Index (NDI) questionnaire.
The total score ranges from 0 to 50, with higher scores indicating greater neck-related disability and functional limitation.
Measured: Baseline and after 6 weeks
Health-Related Quality of Life (WHOQOL-BREF)
QQuality of life is assessed using the Turkish validated version of the World Health Organization Quality of Life Questionnaire-Brief Form (WHOQOL-BREF). Domain scores are transformed to a 0-100 scale, with higher scores on the questionnaire indicating better perceived quality of life.
Measured: Baseline and after 6 weeks
Sleep Quality (Pittsburgh Sleep Quality Index)
Sleep quality is assessed using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: Baseline and after 6 weeks
Emotional Status - Depression (Beck Depression Inventory)
Emotional status related to depressive symptoms is assessed using the Beck Depression Inventory (BDI). The total score ranges from 0 to 63, with higher scores indicating greater severity of depressive symptoms.
Measured: Baseline and after 6 weeks
Emotional Status - Anxiety (Beck Anxiety Inventory)
Emotional status related to anxiety symptoms is assessed using the Beck Anxiety Inventory (BAI). The total score ranges from 0 to 63, with higher scores indicating greater severity of anxiety symptoms.
Measured: Baseline and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start15 Dec 2023
- Primary completion21 Nov 2025
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMDs)Studies 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
- Model description
- This study was designed as a parallel-group interventional clinical trial. Participants who agreed to participate in the study were randomly assigned into two groups using a block randomization method. Each group received a different physiotherapy and rehabilitation program during the same study period. Recruitment has been completed, and no new participants are being enrolled. Participants continue to receive the assigned interventions and complete the planned assessments while remaining in their allocated groups throughout the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Polen Hazımoğlu, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392671
- Sponsor's protocol ID
- KA-22078
- Status last verified
- Jun 2026
- First submitted
- 12 Jan 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside the research team. The data are collected as part of a doctoral thesis and will be used only for the purposes defined in the study protocol and related scientific publications, in accordance with ethical approval and data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Limbic System-Oriented Combined Manual Therapy on Pain, Joint Range of Motion, Muscle Strength, Joint Position Sense, Balance, Functional Status, Emotional State, Quality of Life, and Sleep Quality in Temporomandibular Joint Dysfunction
- ClinicalTrials.gov ID
- NCT07392671
- Acronym / sponsor ID
- KA-22078
- Conditions
- Temporomandibular Disorders (TMDs)
- Keywords
- temporomandibular joint disorders, Physiotherapy, Manual therapy, Limbic system, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 6 Feb 2026 (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.
Temporomandibular joint disorders (TMD) are common conditions that may cause jaw pain, limited jaw movement, and reduced quality of life. Individuals with TMD can also experience neck-related problems, balance impairments, emotional changes, and sleep disturbances.
This interventional study aims to investigate the effects of a combined physiotherapy and rehabilitation program in individuals with temporomandibular joint dysfunction. The intervention consists of conventional manual therapy techniques applied to the temporomandibular joint and cervical region, combined with specific manual therapy techniques targeting the limbic system, along with therapeutic exercise applications.
The study will evaluate the effects of this combined treatment approach on pain, jaw range of motion, joint position sense, balance, emotional status, patient satisfaction, and quality of life and sleep in individuals with TMD.
Detailed description
Temporomandibular joint dysfunction is a complex condition that affects the masticatory system and is frequently associated with cervical musculoskeletal impairments, altered sensorimotor control, and psychosocial factors. In addition to local biomechanical dysfunctions, individuals with temporomandibular disorders may experience changes in pain processing, emotional regulation, balance, and overall quality of life. These factors highlight the need for a comprehensive rehabilitation approach that addresses both peripheral and central mechanisms.
Physiotherapy and rehabilitation interventions for temporomandibular joint dysfunction traditionally focus on the temporomandibular joint and cervical region using manual therapy techniques and therapeutic exercises. While these approaches are effective in improving physical impairments, emerging evidence suggests that central mechanisms, including the limbic system, may influence pain perception, emotional status, and functional outcomes in individuals with temporomandibular disorders.
This interventional study is designed to investigate the effects of a combined physiotherapy and rehabilitation approach that integrates conventional manual therapy techniques applied to the temporomandibular joint and cervical region with specific manual therapy techniques oriented toward the limbic system, along with therapeutic exercise applications. The combined approach aims to address musculoskeletal, sensorimotor, and emotional components of temporomandibular joint dysfunction within a holistic rehabilitation framework.
Participants diagnosed with temporomandibular joint dysfunction will undergo the intervention program and will be evaluated before and after the treatment period. The study focuses on changes in pain, jaw function, sensorimotor control, balance, emotional status, patient satisfaction, and quality of life and sleep, providing a multidimensional assessment of treatment effects.
By examining the outcomes of this combined intervention, the study seeks to enhance the understanding of integrative physiotherapy strategies in the management of temporomandibular joint dysfunction and to support the development of more comprehensive rehabilitation approaches that consider both physical and emotional aspects of the condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study was designed as a parallel-group interventional clinical trial. Participants who agreed to participate in the study were randomly assigned into two groups using a block randomization method. Each group received a different physiotherapy and rehabilitation program during the same study period. Recruitment has been completed, and no new participants are being enrolled. Participants continue to receive the assigned interventions and complete the planned assessments while remaining in their allocated groups throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Conventional Manual Therapy + Exercise Program | Active comparator | Other: Conventional Physiotherapy and Rehabilitation ProgramParticipants in this arm receive a conventional physiotherapy and rehabilitation program consisting of manual therapy applied to the temporomandibular joint and cervical region, supervised therapeutic exercises, and a structured home exercise program. No limbic-oriented manual therapy techniques are included in this arm. |
| Conventional Program + Limbic-Oriented Manual Therapy | Experimental | Other: Conventional Physiotherapy and Rehabilitation Program, Other: Limbic-Oriented Manual TherapyParticipants in this arm receive the same conventional physiotherapy and rehabilitation program, including temporomandibular joint and cervical manual therapy, supervised therapeutic exercises, and a home exercise program, with the addition of limbic-oriented manual therapy techniques aimed at modulating central pain processing and emotional regulation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Aged between 18 and 60 years
- Diagnosed with temporomandibular joint dysfunction (TMD - disc displacement or degenerative joint disease) by an Oral and Maxillofacial Surgery specialist
- Clinical findings consistent with temporomandibular joint dysfunction
- Presence of symptoms and pain related to TMD for at least 6 months
- No history of acute trauma, infection, or neurological disease
Key exclusion criteria (10 listed)
- History of jaw and/or cervical region surgery or trauma within the last 6 months
- Presence of rheumatological or psychiatric disorders
- History of fracture involving the temporomandibular joint, cervical, or upper thoracic region
- Presence of acute cervical disc pathology or other acute conditions affecting the cervical region
- Presence of skin infection or open wounds
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 |
|---|---|---|
| Conventional Physiotherapy and Rehabilitation ProgramThe intervention is delivered over a 6-week period. Manual therapy techniques applied to the cervical region and temporomandibular joint, along with supervised jaw exercises, are administered twice per week. In addition, participants perform postural exercises as part of a home exercise program for 6 weeks, 5 days per week, three times per day, with 10 repetitions per exercise. All interventions are administered by a physiotherapist according to a standardized physiotherapy protocol. | Other | Conventional Manual Therapy + Exercise Program, Conventional Program + Limbic-Oriented Manual Therapy |
| Limbic-Oriented Manual TherapyIn addition to the conventional physiotherapy and rehabilitation program, limbic-oriented manual therapy techniques are applied over a 6-week period. Three limbic-oriented manual therapy techniques are administered during each session, with each technique applied for an average duration of approximately 3 minutes. These techniques are administered twice per week by a physiotherapist according to the study protocol. The limbic-oriented manual therapy is delivered alongside manual therapy to the cervical region and temporomandibular joint, supervised jaw exercises, and a structured home exercise program. | Other | Conventional Program + Limbic-Oriented Manual Therapy |
Primary outcome
Pain Intensity at Rest (Visual Analog Scale)
Time frame: Baseline and after 6 weeks
Pain intensity at rest is assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 to 10 cm. A score of 0 indicates no pain and a score of 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity. The distance from the left end of the scale to the marked point is measured using a ruler and recorded in centimeters (cm).
Pressure Pain Threshold (Algometry)
Time frame: Baseline and after 6 weeks
Pressure pain threshold is assessed using a handheld pressure algometer. Measurements are performed bilaterally at three anatomical sites: the temporomandibular joint region, masseter muscle, and temporalis muscles, and recorded in Newton (N). At each site, three consecutive measurements are taken, and the mean value is calculated for analysis. Higher values indicate greater pressure pain tolerance, whereas lower values indicate increased pain sensitivity. Assessments are conducted at baseline and at the end of the treatment period.
Cervical Joint Position Sense
Time frame: Baseline and after 6 weeks
Cervical joint position sense is assessed during flexion-extension, right and left rotation, and right and left lateral flexion movements using target angle tests and the head repositioning test. Flexion, extension, and rotation movements are assessed at mid-range positions (50% of the available range of motion) and at target angles of 10° and 30°. Lateral flexion movements are assessed at target angles of 10° and 20°, as well as at mid-range positions (50% of the available range of motion). During each test, the deviation from the target angle is recorded. The angular error is calculated as the absolute difference between the target angle and the angle achieved by the participant and recorded in degrees (°). Higher angular error values indicate poorer joint position sense, whereas lower values indicate better proprioceptive accuracy. Each test is performed three times with the participant's eyes closed, and the mean value of the three measurements is recorded for analysis.
Temporomandibular Joint Range of Motion
Time frame: Baseline and after 6 weeks
Temporomandibular joint range of motion is assessed using a digital caliper. Pain-free maximum mouth opening, right and left lateral excursions, and mandibular protrusion movements are measured. All measurements are recorded in millimeters (mm) for analysis. Higher values indicate greater mandibular mobility, whereas lower values indicate restricted temporomandibular joint range of motion.
Cervical Joint Range of Motion
Time frame: Baseline and after 6 weeks
Cervical joint flexion, extension, bilateral lateral flexion, and rotation movements are evaluated using a cervical range of motion (CROM) device. Measurements are recorded in degrees (°). Higher values indicate greater cervical mobility, whereas lower values indicate restricted cervical range of motion.
Static Balance (Flamingo Balance Test)
Time frame: Baseline and after 6 weeks
Static balance is assessed using the Flamingo Balance Test. Participants are instructed to stand on a wooden balance beam and maintain balance on one lower extremity. The test is performed on the participant's dominant extremity. Timing begins when the participant achieves single-leg stance, and the participant is asked to maintain balance for one minute without falling. During the one-minute period, each attempt to regain balance after a loss of balance is counted. The total number of balance attempts recorded during the test constitutes the participant's score. Higher scores indicate poorer static balance performance, whereas lower scores indicate better balance control.
Dynamic Balance (Y Balance Test)
Time frame: Baseline and after 6 weeks
Dynamic balance is assessed using the Y Balance Test. The test is performed in the anterior, posteromedial, and posterolateral directions. Participants perform three trials in each direction, and the mean value of the three measurements is calculated for analysis. Reach distances are recorded in centimeters (cm). Higher reach distances indicate better dynamic balance performance, whereas lower values indicate reduced balance ability.
Pain Intensity During Chewing (Visual Analog Scale)
Time frame: Baseline and after 6 weeks
Pain intensity during chewing is assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 to 10 cm. Pain is evaluated separately during chewing of hard and soft food. A score of 0 indicates no pain, and a score of 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity. The distance from the left end of the scale to the marked point is measured using a ruler and recorded in centimeters (cm).
Pain Intensity During Biting (Visual Analog Scale)
Time frame: Baseline and after 6 weeks
Pain intensity during biting is assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 to 10 cm. A score of 0 indicates no pain, and a score of 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity. The distance from the left end of the scale to the marked point is measured using a ruler and recorded in centimeters (cm).
Pain Intensity During Night-Time (Visual Analog Scale)
Time frame: Baseline and after 6 weeks
Night-time pain intensity is assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 to 10 cm. A score of 0 indicates no pain, and a score of 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity. The distance from the left end of the scale to the marked point is measured using a ruler and recorded in centimeters (cm).
Pain Intensity During Yawning
Time frame: Baseline and after 6 weeks
Pain intensity during yawning is assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 to 10 cm. A score of 0 indicates no pain, and a score of 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity. The distance from the left end of the scale to the marked point is measured using a ruler and recorded in centimeters (cm).
Pain Intensity During Eating (Visual Analog Scale)
Time frame: Baseline and after 6 weeks
Pain intensity during eating is assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 to 10 cm. A score of 0 indicates no pain, and a score of 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity. The distance from the left end of the scale to the marked point is measured using a ruler and recorded in centimeters (cm).
Temporomandibular Joint Dysfunction Severity (Fonseca Anamnestic Questionnaire)
Time frame: Baseline and after 6 weeks
Temporomandibular joint functional status is assessed using the Turkish version of the Fonseca Anamnestic Questionnaire. The total score ranges from 0 to 100, with higher scores indicating greater severity of temporomandibular joint dysfunction.
Mandibular Functional Impairment (Mandibular Function Impairment Questionnaire)
Time frame: Baseline and after 6 weeks
Mandibular functional status is assessed using the Turkish version of the Mandibular Function Impairment Questionnaire. The total score ranges from 0 to 68, with higher scores indicating greater functional impairment
9 secondary outcomes
Chewing Quality (Visual Analog Scale)
Time frame: Baseline and after 6 weeks
Patient Satisfaction With Treatment (Visual Analog Scale)
Time frame: At the end of the treatment period (6 weeks)
Postural Assessment
Time frame: Baseline and after 6 weeks
Deep Cervical Flexor Muscle Strength
Time frame: Baseline and after 6 weeks
Neck Disability
Time frame: Baseline and after 6 weeks
Health-Related Quality of Life (WHOQOL-BREF)
Time frame: Baseline and after 6 weeks
Sleep Quality (Pittsburgh Sleep Quality Index)
Time frame: Baseline and after 6 weeks
Emotional Status - Depression (Beck Depression Inventory)
Time frame: Baseline and after 6 weeks
Emotional Status - Anxiety (Beck Anxiety Inventory)
Time frame: Baseline and after 6 weeks
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 24 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside the research team. The data are collected as part of a doctoral thesis and will be used only for the purposes defined in the study protocol and related scientific publications, in accordance with ethical approval and data protection regulations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physiotherapy and Rehabilitation Program and Limbic-Oriented Manual Therapy in people with Temporomandibular Disorders (TMDs), run by Hacettepe University at 1 site 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 10 inclusion and 10 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 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Pain Intensity at Rest (Visual Analog Scale) (time frame: Baseline and after 6 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2026.