Investigation of the Effects of Different Treatment Approaches in Jaw (Temporomandibular) Joint Disorders

NCT07392671 | Active Not Recruiting

• 1 other identifier: KA-22078
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Temporomandibular Disorders (TMDs)

Keywords

temporomandibular joint disorders; Physiotherapy; Manual therapy; Limbic system; Pain

Outcome Measures

Primary Outcomes (14)

• 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).

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  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).

  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).

  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).

  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).

  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.

  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

  Baseline and after 6 weeks

Secondary Outcomes (9)

• Chewing Quality (Visual Analog Scale)

  Baseline and after 6 weeks

• Patient Satisfaction With Treatment (Visual Analog Scale)

  At the end of the treatment period (6 weeks)

• Postural Assessment

  Baseline and after 6 weeks

• Deep Cervical Flexor Muscle Strength

  Baseline and after 6 weeks

• Neck Disability

  Baseline and after 6 weeks

Study Arms (2)

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.

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.

Other: Conventional Physiotherapy and Rehabilitation Program; Other: Limbic-Oriented Manual Therapy

Interventions

Limbic-Oriented Manual Therapy OTHER

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.

Conventional Program + Limbic-Oriented Manual Therapy

Conventional Physiotherapy and Rehabilitation Program OTHER

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.

Conventional Manual Therapy + Exercise Program; Conventional Program + Limbic-Oriented Manual Therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Faculty of Physical Therapy and Rehabilitation, Musculoskeletal Physiotherapy and Rehabilitation Unit

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Pain

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only participants were blinded to group allocation. No other parties were masked in this clinical trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: February 6, 2026
• Study Start: December 15, 2023
• Primary Completion: November 21, 2025
• Study Completion: February 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)