Back to resultsPulsed Electromagnetic Field Therapy for TMJ Dysfunction After Facial Penetrating Injury
Primary Purpose
TMJ Disorder
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pulsed Electromagnetic Field therapy (PEMFT)
TMJ physical therapy program
Sponsored by
About this trial
This is an interventional treatment trial for TMJ Disorder
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.
Sites / Locations
- Kafrelsheikh University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Study Group
Arm Description
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.
Study group patients received PEMFT, using EMG 8400 PEMF device (made in Italy, by EME) in addition to physical therapy treatment program.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04561037
First Posted
September 17, 2020
Last Updated
February 17, 2021
Sponsor
Kafrelsheikh University
1. Study Identification
Unique Protocol Identification Number
NCT04561037
Brief Title
Pulsed Electromagnetic Field Therapy for TMJ Dysfunction After Facial Penetrating Injury
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 20, 2019 (Actual)
Primary Completion Date
October 2, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TMJ Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Study Group
Arm Type
Experimental
Arm Description
Study group patients received PEMFT, using EMG 8400 PEMF device (made in Italy, by EME) in addition to physical therapy treatment program.
Intervention Type
Device
Intervention Name(s)
Pulsed Electromagnetic Field therapy (PEMFT)
Intervention Description
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
Other
Intervention Name(s)
TMJ physical therapy program
Intervention Description
TMJ manual physical therapy program (mobilization and gentle isometric exercises) for 30, 3 times a week, for 4 weeks.
Primary Outcome Measure Information:
Title
Change in the Maximum mouth opening in millimeter (mm) before and after intervention.
Description
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 Outcome Measure Information:
Title
Change in TMJ pain measured by Visual Analogue Scale (VAS)
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Kadry, PhD
Organizational Affiliation
Kafrelsheikh University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kafrelsheikh University
City
Kafr Ash Shaykh
State/Province
Kafr El Sheikh
ZIP/Postal Code
33516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be shared with other researchers upon request and after discussion with the research team
Learn more about this trial
Pulsed Electromagnetic Field Therapy for TMJ Dysfunction After Facial Penetrating Injury
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