Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to evaluate whether different rehabilitation approaches can improve pain, function, and postural control in individuals with temporomandibular disorders (TMD). The study focuses on adults diagnosed with myogenic TMD.
The main questions it aims to answer are:
Does osteopathic manipulative treatment (OMT) reduce pain and improve functional outcomes in individuals with TMD? Does a structured home-based exercise program improve postural control and sensorimotor function in individuals with TMD? Researchers will compare osteopathic manipulative treatment (OMT) and a home-based exercise program to determine their relative effects on pain, function, and postural stability.
Participants will:
Be randomly assigned to either the OMT group or the exercise group Receive the assigned intervention over the study period Undergo assessments before and after treatment, including pain intensity, pressure pain threshold, mandibular movements, cervical range of motion, postural stability, and quality of life
Temporomandibular disorders (TMD) are multifactorial conditions characterized by pain, functional limitations, and alterations in sensorimotor control. Although various rehabilitation approaches are commonly used in clinical practice, the relationship between TMD and postural stability remains unclear, particularly regarding the differential effects of specific treatment strategies.
This randomized controlled trial aims to compare the effects of osteopathic manipulative treatment (OMT) and a structured home-based exercise program on pain, functional outcomes, and postural control in individuals with myogenic TMD.
Participants diagnosed with myogenic TMD are randomly allocated to either an OMT group or a home-based exercise group. The OMT intervention consists of manual techniques targeting the temporomandibular joint and related musculoskeletal structures, while the exercise program includes structured therapeutic exercises designed to improve mobility, muscle function, and sensorimotor control.
Outcome measures include pain intensity assessed using the Visual Analog Scale (VAS), pressure pain threshold, mandibular movements, cervical range of motion (ROM), postural stability parameters, and quality of life. All assessments are performed before and after the intervention period by a blinded assessor.
This study is designed to explore whether different rehabilitation approaches produce distinct effects on pain reduction, functional improvement, and postural control, thereby contributing to a better understanding of mechanism-based rehabilitation strategies in TMD.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OMT Group | Experimental | Participants receive osteopathic manipulative treatment targeting the temporomandibular joint and related structures. |
|
| Home-Based Exercise Group | Active Comparator | Participants perform a structured home-based exercise program targeting jaw and cervical function. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-based Exercise Program | Behavioral | A structured home-based exercise program designed to improve mandibular mobility, cervical function, and sensorimotor control. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity (Visual Analog Scale, VAS) | Pain intensity will be assessed using the Visual Analog Scale (VAS), where participants rate their pain on a scale from 0 (no pain) to 10 (worst pain imaginable). | Before intervention and immediately after the intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| Pressure Pain Threshold | Pressure pain threshold will be measured using a digital algometer applied to the anterior temporalis muscle, masseter muscle, and temporomandibular joint region. The average of three measurements will be recorded. | Before intervention and immediately after the intervention period |
Not provided
Inclusion Criteria:
TMD Group:
Control Group:
Exclusion Criteria:
TMD Group:
Control Group:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alanya Alaaddin Keykubat University | Antalya | Alanya | 07400 | Turkey (Türkiye) |
Individual participant data (IPD) will not be shared due to privacy and confidentiality concerns in accordance with data protection regulations. De-identified data may be made available from the corresponding author upon reasonable request, subject to ethical approval and institutional policies.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D026301 | Manipulation, Osteopathic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
Not provided
Not provided
This study is designed as a randomized, parallel-group controlled trial comparing two intervention arms: osteopathic manipulative treatment (OMT) and a structured home-based exercise program. Participants are randomly allocated to one of the two groups using a concealed randomization method. Outcome assessments are conducted by a blinded assessor before and after the intervention period.
Not provided
Not provided
Not provided
| Osteopathic Manipulative Treatment (OMT) | Procedure | A manual therapy intervention consisting of osteopathic manipulative techniques applied to the temporomandibular joint and related musculoskeletal structures. The treatment aims to reduce pain, improve joint mobility, and enhance functional outcomes. |
|
| Mandibular Range of Motion |
Mandibular movements, including maximum mouth opening, lateral movements, and protrusion, will be measured in millimeters using a digital caliper. |
| Before intervention and immediately after the intervention period |
| Cervical Range of Motion | Cervical range of motion will be assessed to evaluate neck mobility associated with temporomandibular function. | Before intervention and immediately after the intervention period |
| Postural Stability | Postural stability will be assessed using the Lockhart Monitor mobile application during a 30-second static standing task, measuring mediolateral and anteroposterior sway. | Before intervention and immediately after the intervention period |
| Quality of Life (Short Form-12 Health Survey, SF-12) | Quality of life will be assessed using the Short Form-12 Health Survey (SF-12), a validated instrument that evaluates health-related quality of life across physical and mental domains. The SF-12 generates two composite scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each component score is standardized and typically ranges from 0 to 100, with higher scores indicating better health-related quality of life. Scores are calculated using weighted algorithms based on population norms. | Before intervention and immediately after the intervention period |
| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D012046 | Rehabilitation |