Pulsed Electromagnetic Field Therapy for TMJ Dysfunction After Facial Penetrating Injury

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

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

Study Overview

• Status: Completed
• Conditions: TMJ Disorder
• Intervention / Treatment: Other: TMJ physical therapy program; Device: Pulsed Electromagnetic Field therapy (PEMFT)

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Kafr El Sheikh
    • Kafr Ash Shaykh, Kafr El Sheikh, Egypt, 33516
      • Kafrelsheikh University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control Group; Control group patients received traditional physical therapy treatment. The traditional physical therapy treatment program consisted of TMJ mobilization techniques include distraction, anterior glide, anterior glide with pre-positioned mouth opening, medial/lateral glides, caudal-anterior-medial (CAM) glide, and CAM glide with pre-positioned mouth opening 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.
EXPERIMENTAL: Study Group; Study group patients received PEMFT, using EMG 8400 PEMF device (made in Italy, by EME) in addition to physical therapy treatment program.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Kafrelsheikh University
• Investigators: Principal Investigator: Ahmed Kadry, PhD, Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 20, 2019
• Primary Completion (ACTUAL): October 2, 2020
• Study Completion (ACTUAL): October 15, 2020

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (ACTUAL): September 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Temporomandibular Joint Disorders; Wounds, Penetrating
• Other Study ID Numbers: 001 (NavyGHB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be shared with other researchers upon request and after discussion with the research team

Drug and device information, study documents

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