- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07534540
OMT vs Exercise in TMD
Effects of Osteopathic Manipulative Treatment Versus Exercise on Pain, Function, and Dynamic Postural Control in Individuals With Temporomandibular Disorders: A Randomized Controlled Trial
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alanya
-
Antalya, Alanya, Turkey (Türkiye), 07400
- Alanya Alaaddin Keykubat University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
TMD Group:
- Diagnosis of temporomandibular disorder (TMD) confirmed by a dentist
- Pain intensity ≥ 3.5 cm on the Visual Analog Scale (VAS)
- Presence of TMD-related pain for at least 3 months
- Aged between 18 and 50 years
- Willingness to participate in the study
Control Group:
- No history or clinical signs of temporomandibular disorder (TMD)
- Aged between 18 and 50 years
- Willingness to participate in the study
Exclusion Criteria:
TMD Group:
- Presence of any condition other than TMD that may affect the assessment outcomes
- Presence of musculoskeletal pain in any other body region
- Any orthopedic or neurological condition that may interfere with assessments
- Diagnosed psychiatric disorder
- Conditions impairing communication or ability to complete assessments
- Illiteracy
- History of orthopedic surgery in any body region
- Presence of systemic pathological conditions such as fractures, rheumatoid arthritis, or suspected malingering
- Receipt of physiotherapy or other treatment targeting the temporomandibular joint or spinal region within the last 6 months
Control Group:
- History of chronic musculoskeletal disorders within the past year
- Any orthopedic or neurological condition that may interfere with assessments
- Diagnosed psychiatric disorder
- Conditions impairing communication or ability to complete assessments
- Illiteracy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: OMT Group
Participants receive osteopathic manipulative treatment targeting the temporomandibular joint and related structures.
|
A structured home-based exercise program designed to improve mandibular mobility, cervical function, and sensorimotor control.
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.
|
|
Active Comparator: Home-Based Exercise Group
Participants perform a structured home-based exercise program targeting jaw and cervical function.
|
A structured home-based exercise program designed to improve mandibular mobility, cervical function, and sensorimotor control.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity (Visual Analog Scale, VAS)
Time Frame: Before intervention and immediately after the intervention period
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure Pain Threshold
Time Frame: Before intervention and immediately after the intervention period
|
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
|
|
Mandibular Range of Motion
Time Frame: Before intervention and immediately after the intervention period
|
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
Time Frame: Before intervention and immediately after the intervention period
|
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
Time Frame: Before intervention and immediately after the intervention period
|
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)
Time Frame: Before intervention and immediately after the intervention period
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Stomatognathic Diseases
- Muscular Diseases
- Joint Diseases
- Jaw Diseases
- Mandibular Diseases
- Craniomandibular Disorders
- Temporomandibular Joint Disorders
- Therapeutics
- Complementary Therapies
- Physical Therapy Modalities
- Rehabilitation
- Musculoskeletal Manipulations
- Manipulation, Osteopathic
Other Study ID Numbers
- 10.04.2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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