Effectiveness of Different Physiotherapy Practices in Temporomandibular Disorders

The aim of the study is to examine the effect of high voltage electrical stimulation on pain, temporomandibular joint mobility, cervical mobility, head position, tender points and joint sounds in individuals with temporomandibular disorders.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Disorder
• Intervention / Treatment: Other: High voltage electrical stimulation+exercise therapy; Other: Exercise therapy

Detailed Description

28 individuals who meet the TMER / Research Diagnostic Criteria classification will be randomly divided into 2 groups. Exercise with high voltage electrical stimulation (YVES) will be applied to the 1st group and only exercise will be applied to the 2nd group. The second group will be the control group of the study. Both groups will be informed about the disease before starting the study before the treatment and patient education will be given about the situations that need attention. Again, 2 groups will be given an exercise program from the day they start the treatment, 3 times a week for 4 weeks during the treatment. As sociodemographic information of the individuals, age, gender, height, weight, body mass index, marital and educational status, occupation, smoking and alcohol use, patient history, family history and complaint sides will be recorded. Before starting treatment, individuals will be evaluated for pain, temporomandibular joint mobility, cervical mobility, tender points, and joint sounds:

1. Pain with Visual Analogue Scale (VAS),
2. TMJ mobility with a ruler,
3. Cervical mobility with C-ROM (Cervical Range of Motion) inclinometer,
4. Head position with universal goniometer and ImageJ software,
5. Sensitive points with algometer,
6. Joint sounds will be evaluated as present / absent as a result of the evaluation of movements in all directions (maximum mouth opening, right / left lateral excursions, protrusion and retrusion).

After 4 weeks of treatment, the measurements will be repeated.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • None Selected
    • Ankara, None Selected, Turkey, 06490
      • Gazi University, Faculty of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Individuals who have been diagnosed with TMER,
• Comply with the TMD / RDC classification,
• Have Class I-II-III occlusion,
• Volunteer to participate in the study, and fill out the informed consent form will be included.

Exclusion Criteria:

• Acute trauma,
• Surgery history,
• Neurological or psychiatric conditions,
• Trigeminal or postherpatic neuralgia,
• Dental or orofacial infection,
• Intraoral infection or tumor,
• Oligodontics and anadontics,
• High voltage electrical stimulation contraindications,
• Any disease diagnosed in the shoulder and neck areas,
• Receiving another treatment and,
• Individuals under the age of 18 will be excluded in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment group; High voltage electrical stimulation + exercise therapy	Other: High voltage electrical stimulation+exercise therapy; The effect of high voltage electrical stimulation on temporomandibular disorders
ACTIVE_COMPARATOR: Control group; Exercise therapy	Other: Exercise therapy; The effect of high voltage electrical stimulation on temporomandibular disorders

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain on temporomandibular joint	Pain with Visual Analogue Scale (VAS)	Before and after treatment, 4 weeks apart. It takes 10 seconds.
Change in temporomandibular joint mobility	Temporomandibular joint mobility with a ruler	Before and after treatment, 4 weeks apart. It takes 3 minutes.
Change in cervical mobility	Cervical mobility with C-ROM (Cervical Range of Motion) inclinometer	Before and after treatment, 4 weeks apart. It takes 5 minutes.
Change in head position	Head position with universal goniometer and ImageJ software	Before and after treatment, 4 weeks apart. It takes 3 minutes.
Change in tender points	Tender points with algometer	Before and after treatment, 4 weeks apart. It takes 10 minutes.
Change in joint sounds	Joint sounds as present / absent as a result of the evaluation of movements in all directions (maximum mouth opening, right / left lateral excursions, protrusion and retrusion)	Before and after treatment, 4 weeks apart. It takes 2 minutes.

Collaborators and Investigators

• Sponsor: Gazi University
• Investigators: Principal Investigator: Seyit CITAKER, Dr., Gazi University, Faculty of Health Sciences; Principal Investigator: Gokhan MARAS, MSc., Gazi University, Faculty of Health Sciences; Principal Investigator: Halime ARIKAN, MSc., Gazi University, Faculty of Health Sciences; Principal Investigator: Cahit UCOK, Dr., Ankara University, Faculty of Dentistry

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2021
• Primary Completion (ACTUAL): July 1, 2021
• Study Completion (ACTUAL): December 1, 2021

Study Registration Dates

• First Submitted: January 10, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (ACTUAL): January 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 26, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Cervical spine; Temporomandibular disorders; Temporomandibular joint; High voltage stimulation
• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Disease; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: 68869993-511.06-E.239934

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No