NCT07534540

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

April 10, 2026

Last Update Submit

April 10, 2026

Conditions

Keywords

Temporomandibular Joint DisordersManipulationOsteopathicExercise TherapyPain MeasurementPostural Balance

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Pressure Pain Threshold

    Before intervention and immediately after the intervention period

  • Mandibular Range of Motion

    Before intervention and immediately after the intervention period

  • Cervical Range of Motion

    Before intervention and immediately after the intervention period

  • Postural Stability

    Before intervention and immediately after the intervention period

  • Quality of Life (Short Form-12, SF-12)

    Before intervention and immediately after the intervention period

Study Arms (2)

OMT Group

EXPERIMENTAL

Participants receive osteopathic manipulative treatment targeting the temporomandibular joint and related structures.

Behavioral: Home-based Exercise ProgramProcedure: Osteopathic Manipulative Treatment (OMT)

Home-Based Exercise Group

ACTIVE COMPARATOR

Participants perform a structured home-based exercise program targeting jaw and cervical function.

Behavioral: Home-based Exercise ProgramProcedure: Osteopathic Manipulative Treatment (OMT)

Interventions

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

Home-Based Exercise GroupOMT Group

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.

Home-Based Exercise GroupOMT Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alanya Alaaddin Keykubat University

Antalya, Alanya, 07400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Proffesor

Study Record Dates

First Submitted

April 10, 2026

First Posted

April 16, 2026

Study Start

April 1, 2024

Primary Completion

May 15, 2024

Study Completion

December 26, 2025

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations