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Effectiveness of Different Physiotherapy Practices in Temporomandibular Disorders

Primary Purpose

Temporomandibular Disorder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
High voltage electrical stimulation+exercise therapy
Exercise therapy
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorder focused on measuring High voltage stimulation, Temporomandibular disorders, Temporomandibular joint, Cervical spine, Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gazi University, Faculty of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment group

Control group

Arm Description

High voltage electrical stimulation + exercise therapy

Exercise therapy

Outcomes

Primary Outcome Measures

Change in pain on temporomandibular joint
Pain with Visual Analogue Scale (VAS)
Change in temporomandibular joint mobility
Temporomandibular joint mobility with a ruler
Change in cervical mobility
Cervical mobility with C-ROM (Cervical Range of Motion) inclinometer
Change in head position
Head position with universal goniometer and ImageJ software
Change in tender points
Tender points with algometer
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)

Secondary Outcome Measures

Full Information

First Posted
January 10, 2021
Last Updated
May 26, 2022
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT04708938
Brief Title
Effectiveness of Different Physiotherapy Practices in Temporomandibular Disorders
Official Title
Effectiveness of Different Physiotherapy Practices in Temporomandibular Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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: Pain with Visual Analogue Scale (VAS), TMJ mobility with a ruler, Cervical mobility with C-ROM (Cervical Range of Motion) inclinometer, Head position with universal goniometer and ImageJ software, Sensitive points with algometer, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder
Keywords
High voltage stimulation, Temporomandibular disorders, Temporomandibular joint, Cervical spine, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized-controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
High voltage electrical stimulation + exercise therapy
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Exercise therapy
Intervention Type
Other
Intervention Name(s)
High voltage electrical stimulation+exercise therapy
Intervention Description
The effect of high voltage electrical stimulation on temporomandibular disorders
Intervention Type
Other
Intervention Name(s)
Exercise therapy
Intervention Description
The effect of high voltage electrical stimulation on temporomandibular disorders
Primary Outcome Measure Information:
Title
Change in pain on temporomandibular joint
Description
Pain with Visual Analogue Scale (VAS)
Time Frame
Before and after treatment, 4 weeks apart. It takes 10 seconds.
Title
Change in temporomandibular joint mobility
Description
Temporomandibular joint mobility with a ruler
Time Frame
Before and after treatment, 4 weeks apart. It takes 3 minutes.
Title
Change in cervical mobility
Description
Cervical mobility with C-ROM (Cervical Range of Motion) inclinometer
Time Frame
Before and after treatment, 4 weeks apart. It takes 5 minutes.
Title
Change in head position
Description
Head position with universal goniometer and ImageJ software
Time Frame
Before and after treatment, 4 weeks apart. It takes 3 minutes.
Title
Change in tender points
Description
Tender points with algometer
Time Frame
Before and after treatment, 4 weeks apart. It takes 10 minutes.
Title
Change in joint sounds
Description
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)
Time Frame
Before and after treatment, 4 weeks apart. It takes 2 minutes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Halime ARIKAN, MSc.
Organizational Affiliation
Gazi University, Faculty of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gokhan MARAS, MSc.
Organizational Affiliation
Gazi University, Faculty of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seyit CITAKER, Dr.
Organizational Affiliation
Gazi University, Faculty of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cahit UCOK, Dr.
Organizational Affiliation
Ankara University, Faculty of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gazi University, Faculty of Health Sciences
City
Ankara
State/Province
None Selected
ZIP/Postal Code
06490
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Effectiveness of Different Physiotherapy Practices in Temporomandibular Disorders

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