NCT04708938

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

January 10, 2021

Last Update Submit

May 26, 2022

Conditions

Temporomandibular Disorder

Keywords

High voltage stimulationTemporomandibular disordersTemporomandibular jointCervical spinePain

Outcome Measures

Primary Outcomes (6)

  • 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.

Study Arms (2)

Treatment group

EXPERIMENTAL

High voltage electrical stimulation + exercise therapy

Other: High voltage electrical stimulation+exercise therapy

Control group

ACTIVE COMPARATOR

Exercise therapy

Other: Exercise therapy

Interventions

High voltage electrical stimulation+exercise therapyOTHER

The effect of high voltage electrical stimulation on temporomandibular disorders

Treatment group
Exercise therapyOTHER

The effect of high voltage electrical stimulation on temporomandibular disorders

Control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University, Faculty of Health Sciences

Ankara, None Selected, 06490, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint DisordersPain

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Halime ARIKAN, MSc.

    Gazi University, Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR

  • Gokhan MARAS, MSc.

    Gazi University, Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR

  • Seyit CITAKER, Dr.

    Gazi University, Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR

  • Cahit UCOK, Dr.

    Ankara University, Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, randomized-controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

January 10, 2021

First Posted

January 14, 2021

Study Start

February 1, 2021

Primary Completion

July 1, 2021

Study Completion

December 1, 2021

Last Updated

June 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share
Shared Documents
CSR

Locations

TU(1)