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Completed

NCT Number: NCT07534540

OMT vs Exercise in TMD

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

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alanya Alaaddin Keykubat University

Antalya, Alanya, 07400, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home-based Exercise Program

Behavioral

A structured home-based exercise program designed to improve mandibular mobility, cervical function, and sensorimotor control.

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Alanya Alaaddin Keykubat University

Other

Registry information

Official study title

Effects of Osteopathic Manipulative Treatment Versus Exercise on Pain, Function, and Dynamic Postural Control in Individuals With Temporomandibular Disorders: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 16, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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