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CompletedNCT04561037Updated Feb 18, 2021

Pulsed Electromagnetic Field Therapy for TMJ Dysfunction After Facial Penetrating Injury

An interventional study of Pulsed Electromagnetic Field therapy (PEMFT) and TMJ physical therapy program in TMJ Disorder, sponsored by Kafrelsheikh University. Completed at 1 site in Egypt. Open to participants aged 22 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-02-18.

Sponsored by Kafrelsheikh University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Oct 2019, registered Sep 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
22 Years to 40 Years
Sex
All
01

Study 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

02

Conditions studied

  • TMJ Disorder
03

In context

Temporomandibular Joint Disorders

609 studies on the registry are indexed under Temporomandibular Joint Disorders; 160 are open to participants now.

This study's enrollment of 33 is below the median of 46 across 434 interventional studies indexed under Temporomandibular Joint Disorders.

Browse Temporomandibular Joint Disorders studies →

Lead sponsor

Kafrelsheikh University is the lead sponsor of 285 studies on the registry; 110 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
33 participants (actual)

Study arms

  • 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

  • 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)

Interventions

  • DevicePulsed 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

  • OtherTMJ physical therapy program

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Change between baseline and 4 weeks of treatment measures.

Secondary outcomes

  1. 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

    Time frame: Change between baseline and 4 weeks of treatment measures.

07

Study locations

1 site
  • Kafrelsheikh University
    Kafr Ash Shaykh, Kafr El Sheikh 33516, Egypt
08

References and documents

Individual participant data

Plan to share: No — Data will be shared with other researchers upon request and after discussion with the research team

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04561037
Lead sponsor
Kafrelsheikh University
Responsible party
Ahmed Mahmoud Kadry (Lecturer, Kafrelsheikh University) — Principal investigator
First posted
Sep 23, 2020
Start date
Oct 20, 2019
Primary completion
Oct 2, 2020
Completion
Oct 15, 2020
Last update
Feb 18, 2021

Study contacts

Ahmed Kadry, PhD
principal investigator · Kafrelsheikh University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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