Pulsed Electromagnetic Field Therapy for TMJ Dysfunction After Facial Penetrating Injury

NCT04561037 | Completed

• 1 other identifier: 001
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

TMJ Disorder

Outcome Measures

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

  Change between baseline and 4 weeks of treatment measures.

Secondary Outcomes (1)

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

  Change between baseline and 4 weeks of treatment measures.

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Study Group

EXPERIMENTAL

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

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

Study Group

TMJ physical therapy program OTHER

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

Control Group

Eligibility Criteria

• Age: 22 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

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

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Ahmed Kadry, PhD

  Kafrelsheikh University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 23, 2020
• Study Start: October 20, 2019
• Primary Completion: October 2, 2020
• Study Completion: October 15, 2020
• Last Updated: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)