Pulsed Electromagnetic Field Therapy for TMJ Dysfunction After Facial Penetrating Injury

NCT ID: NCT04561037

Last Updated: 2021-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-20
• Study Completion Date: 2020-10-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

TMJ physical therapy program

Intervention Type: OTHER

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

Study Group

Study group patients received PEMFT, using EMG 8400 PEMF device (made in Italy, by EME) in addition to physical therapy treatment program.

Group Type: EXPERIMENTAL

Pulsed Electromagnetic Field therapy (PEMFT)

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

TMJ physical therapy program

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mahmoud Kadry

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Kadry, PhD

Role: PRINCIPAL_INVESTIGATOR

Kafrelsheikh University

Locations

Kafrelsheikh University

Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt

Countries

Egypt

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id