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Completed

NCT Number: NCT04561037

Pulsed Electromagnetic Field Therapy for TMJ Dysfunction After Facial Penetrating Injury

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

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Key information

Age range

22 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulsed Electromagnetic Field therapy (PEMFT)

Device

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

TMJ physical therapy program

Other

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

Primary outcomes

  1. Change in the Maximum mouth opening in millimeter (mm) before and after intervention.

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

    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

Secondary outcomes

  1. Change in TMJ pain measured by Visual Analogue Scale (VAS)

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

    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

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 23, 2020
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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