Pulsed Electromagnetic Field Therapy for TMJ Dysfunction After Facial Penetrating Injury

TMJ Disorder Clinical Trial

Official title:

Efficacy of Adding Pulsed Electromagnetic Field Therapy to Mobilization and Exercises in Patients With TMJ Dysfunction After Facial Penetrating Injury: Randomized Single-blinded Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04561037
• Other study ID #: 001
• Status: Completed
• Phase: N/A
• Start date: October 20, 2019
• Est. completion date: October 15, 2020

Study information

• Verified date: February 2021
• Source: Kafrelsheikh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is aiming to investigate the effect of magnetic therapy in combination with traditional physical therapy on the pain and mouth opening, after facial penetrating wound injury with no facial fractures, that treated conservatively

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 15, 2020
• Est. primary completion date: October 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 40 Years

Eligibility

Inclusion Criteria:

• TMJ pain and mouth opening limitation after 1 month of facial penetrating wound injury as the wound is fully healed.

• TMJ pain (in 1 or both joints) after facial penetrating wound injury.

Exclusion Criteria:

• Patient excluded from the study if they had one of the following:

• TMJ fracture or dislocation

• Previous TMJ surgeries

• Dental diseases

• Infectious or systemic diseases

• Pregnancy

• Malignancy

• Pacemaker or metal implants

• Systemic diseases that affect joint function such as rheumatoid arthritis.

Related Conditions & MeSH terms

• Temporomandibular Joint Disorders
• TMJ Disorder
• Wounds, Penetrating

Intervention

Device:
• Pulsed Electromagnetic Field therapy (PEMFT)
PEMFT was connected to electrical mains supplying 220v. Pair of applicators sized 16x10x3 cm was adjust to be over TMJ, on both sides of the face; the appliance was adjusted to the frequency of 50 HZ and intensity of 90 Gauss. Twelve PEMF treatment sessions of 30 min duration were provided 3 times per week TMJ mobilization techniques and isometric exercises against resistance for muscles of mastication

Other:
• TMJ physical therapy program
TMJ manual physical therapy program (mobilization and gentle isometric exercises) for 30, 3 times a week, for 4 weeks.

Locations

Country	Name	City	State
Egypt	Kafrelsheikh University	Kafr Ash Shaykh	Kafr El Sheikh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Maximum mouth opening in millimeter (mm) before and after intervention.	Each participant was asked to open his or her mouth as wide as possible after that the examiner used a digital Vernier caliper to measure the maximum vertical distance from the incisal edge of the upper central incisors to the incisal edge of the lower central incisors at the midline	Change between baseline and 4 weeks of treatment measures.
Secondary	Change in TMJ pain measured by Visual Analogue Scale (VAS)	Visual Analogue Scale (VAS) was used to evaluate pain intensity. VAS is a subjective pain measurement method consisting of a straight line of 100 mm on which patients scored their pain intensity where 0 corresponds to no pain and 10 corresponds to the worst maximum pain	Change between baseline and 4 weeks of treatment measures.