NCT06472141

Brief Summary

It is planned to examine the effect of cervical stabilization exercises on Temporomandibular Joint (TMJ) symptoms in individuals with TMJ disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

June 24, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2025

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

June 10, 2024

Last Update Submit

March 23, 2025

Conditions

Keywords

Temporomandibular Joint Disorders

Outcome Measures

Primary Outcomes (5)

  • Numeric Pain Rating Scale (NPRS)

    TMJ pain will be evaluated at rest with the NPRS scale. It is a scale scored between 0-10 points and '0 points means 'I have no pain' and '10 points means 'I have unbearable pain'. NRS score between 1-3 points indicates mild pain, between 4-6 points indicates moderate pain and between 7-10 points indicates severe pain.

    Change from baseline at 8 weeks

  • Fonseca Anamnestic Index (FAI)

    It assesses TMJ disorder and its severity. The index includes three options: "yes" (10 points), "sometimes" (5 points) and "no" (0 points). A total score of 0-15 is considered as no TMJ disorder, 20-40 as mild, 45-65 as moderate, and 70-100 as severe.

    Change from baseline at 8 weeks

  • Cervical Posture

    Cervical posture will be evaluated from the craniovertebral angle.

    Change from baseline at 8 weeks

  • Cervical Mobility

    For cervical mobility, normal joint movements of the neck will be evaluated with a goniometer.

    Change from baseline at 8 weeks

  • Cervical Muscle Performance

    Cervical muscle performance will be evaluated with the craniocervical flexion test.

    Change from baseline at 8 weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

The control group will receive a standard treatment (education + home exercises) program.

Other: Standard treatment (Education + home exercises)

Stabilization group

EXPERIMENTAL

The stabilization group will receive cervical stabilization exercises in addition to standard treatment.

Other: Cervical stabilization exercisesOther: Standard treatment (Education + home exercises)

Interventions

Cervical Stabilization Exercises will be performed 3 days a week for 8 weeks.

Stabilization group

Individuals will be informed about TMJ disorders, parafunctional activities (chewing gum, nail/pen biting, etc.) and recommendations. In addition, Rocabado exercises will be given as a home program.

Control groupStabilization group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having a TMJ disorder according to the TMJ Disorders Research Diagnostic Criteria (RDC/TMD),
  • Being between the ages of 18-65,

You may not qualify if:

  • Neurological diseases (such as Multiple Sclerosis, Parkinson's disease),
  • Metabolic and systemic diseases (such as Hypothyroidism, Hypercalcemia, Diabetes mellitus, Celiac disease),
  • Rheumatologic diseases (such as Rheumatoid arthritis, Scleroderma),
  • History of head and spine trauma/surgery in the last 6 months,
  • History of malignancy and pregnant women will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bitlis Eren Üniversitesi

Merkez, Bitlis, 13000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study was planned as a randomized controlled trial. The individuals included in the study will be divided into 2 groups as Stabilization and Control group by block randomization method.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 10, 2024

First Posted

June 24, 2024

Study Start

June 24, 2024

Primary Completion

March 21, 2025

Study Completion

March 21, 2025

Last Updated

March 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations