TMJ DisorderNCT04561037
Pulsed Electromagnetic Field Therapy for TMJ Dysfunction After Facial Penetrating Injury
A study testing Pulsed Electromagnetic Field therapy (PEMFT) and TMJ physical therapy program in people with TMJ Disorder, run by Kafrelsheikh University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 22 to 40 years
- Conditions the study is for
- TMJ Disorder
- What is being tested?
- Pulsed Electromagnetic Field therapy (PEMFT) and TMJ physical therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2019to 15 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Malignancy
- Pacemaker or metal implants
- Systemic diseases that affect joint function such as rheumatoid arthritis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kafrelsheikh University
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33516
About this study
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
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
- Being tested
- Pulsed Electromagnetic Field therapy (PEMFT), TMJ physical therapy program
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 programOther
TMJ manual physical therapy program (mobilization and gentle isometric exercises) for 30, 3 times a week, for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Pulsed Electromagnetic Field therapy (PEMFT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change between baseline and 4 weeks of treatment measures.
Secondary outcomes (1)
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
Measured: Change between baseline and 4 weeks of treatment measures.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start20 Oct 2019
- Primary completion2 Oct 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ DisorderStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahmoud Kadry, Kafrelsheikh University
- Investigators
- Ahmed Kadry, PhD, Principal investigator, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561037
- Sponsor's protocol ID
- 001
- Status last verified
- Feb 2021
- First submitted
- 17 Sep 2020
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared with other researchers upon request and after discussion with the research team
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04561037
- Acronym / sponsor ID
- 001
- Conditions
- TMJ Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 20 Oct 2019 (actual)
- Primary completion
- 2 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: TMJ physical therapy programControl 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 | Experimental | Device: Pulsed Electromagnetic Field therapy (PEMFT)Study group patients received PEMFT, using EMG 8400 PEMF device (made in Italy, by EME) in addition to physical therapy treatment program. |
Who may qualify
- Ages
- 22 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Study Group |
| TMJ physical therapy programTMJ manual physical therapy program (mobilization and gentle isometric exercises) for 30, 3 times a week, for 4 weeks. | Other | Control Group |
Primary outcome
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
1 secondary outcome
Change in TMJ pain measured by Visual Analogue Scale (VAS)
Time frame: Change between baseline and 4 weeks of treatment measures.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Individual participant dataSharing planned: No. Data will be shared with other researchers upon request and after discussion with the research team
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Kadry, PhD principal investigator
Kafrelsheikh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Electromagnetic Field therapy (PEMFT) and TMJ physical therapy program in people with TMJ Disorder, run by Kafrelsheikh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Maximum mouth opening in millimeter (mm) before and after intervention. (time frame: Change between baseline and 4 weeks of treatment measures.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.