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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04561037
Other study ID # 001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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