Trigeminal NeuralgiaNCT05075707
Comparison Between Magnetic Field and Laser Therapy in Management of Trigeminal Neuralgia
A study testing Electromagnetic therapy. and Low level laser therapy (LLLT) in people with Trigeminal Neuralgia, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
Trigeminal neuralgia (TN) was defined by The International Association for the Study of Pain (IASP) as severe, sudden, usually unilateral, stabbing, brief, recurrent attacks of pain in one or more distributional branches of the trigeminal nerve. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- Electromagnetic therapy. and Low level laser therapy (LLLT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2021to 23 Feb 2022
- 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All participants will between the ages of 25 and 45, will of both sexes (male and female), diabetic type two patients with chronic trigeminal neuralgia, (from three to six months).
- Patients will awake, cooperative, and free of psychiatric issues (as determined by a psychologist) as well as difficulties resulting from orthopaedic or special sensory deficits.
Who cannot join
- Patients will ruled out if they developed TN due to a tumour, herpes zoster, or any other reason other than diabetes, such as significant coagulation dysfunction, cardiopulmonary dysfunction or previous invasive treatment (ethanol, radiofrequency, Gama-knife microvascular decompression, glycerinum injection).
- They will not have a previous disability in the face.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnetic Field and Laser Therapy in Management of Diabetic Trigeminal Neuralgia
Trigeminal neuralgia (TN) was defined by The International Association for the Study of Pain (IASP) as severe, sudden, usually unilateral, stabbing, brief, recurrent attacks of pain in one or more distributional branches of the trigeminal nerve. The purpose of the current study will to investigate the effect of Low level laser therapy versus electromagnetic therapy on diabetic trigeminal neuralgia pain intensity and amplitude of the compound muscle action potential of the masseter and temporalis muscles in diabetic TN patients.
- Conditions
- Trigeminal Neuralgia
- Being tested
- Electromagnetic therapy., Low level laser therapy (LLLT)
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromagnetic therapy.Other
Electromagnetic therapy will be applied for 20 min/ session for (3 days/ week for two months) to the group intervention.
Low level laser therapy (LLLT)Other
Low level laser therapy (LLLT) will be applied for 20 min/session laser scanner for three days each week for two months to the group intervention.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Participants will receive the descriptive medication by neurologist |
| electromagnetic group | Experimental | Participants will receive the descriptive medication by neurologist in addition to electromagnetic therapy. Electromagnetic therapy will be applied for 20 min/session for three days each week for two months. Receives: Other: Electromagnetic therapy. |
| low laser therapy group | Experimental | Participants will receive the descriptive medication by neurologist in addition to low laser therapy. Low laser therapy will be applied for 20 min/session for three days each week for two months. Receives: Other: Low level laser therapy (LLLT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Studies using electromyography and complex muscle action potentials
All patients' compound motor action potential amplitudes in the masseter and temporalis muscles will be evaluated before interventions.
Measured: at the beginning of the study
Studies using electromyography and complex muscle action potentials
All patients' compound motor action potential amplitudes in the masseter and temporalis muscles will be evaluated after two month of interventions.
Measured: by the end of successful two month of intervention
Visual analogue scale (VAS)
All the participants were instructed to express their pain by Visual analogue scale (VAS) before the interventions.
Measured: at the beginning of the study
Visual analogue scale (VAS)
All the participants were instructed to express their pain by Visual analogue scale (VAS) after two month of interventions.
Measured: by the end of successful two month of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start15 Oct 2021
- Primary completion22 Feb 2022
- Study completion23 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Hussin Hussin Mohammed, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075707
- Sponsor's protocol ID
- magnetic and laser therapy
- Status last verified
- Mar 2022
- First submitted
- 19 Sep 2021
- Last updated
- 16 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be available to other researchers after 12 month from publishing.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Field and Laser Therapy in Management of Diabetic Trigeminal Neuralgia
- ClinicalTrials.gov ID
- NCT05075707
- Acronym / sponsor ID
- magnetic and laser therapy
- Conditions
- Trigeminal Neuralgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 23 Feb 2022 (actual)
- First posted
- 13 Oct 2021 (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.
Trigeminal neuralgia (TN) was defined by The International Association for the Study of Pain (IASP) as severe, sudden, usually unilateral, stabbing, brief, recurrent attacks of pain in one or more distributional branches of the trigeminal nerve. The purpose of the current study will to investigate the effect of Low level laser therapy versus electromagnetic therapy on diabetic trigeminal neuralgia pain intensity and amplitude of the compound muscle action potential of the masseter and temporalis muscles in diabetic TN patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Participants will receive the descriptive medication by neurologist |
| electromagnetic group | Experimental | Other: Electromagnetic therapy.Participants will receive the descriptive medication by neurologist in addition to electromagnetic therapy. Electromagnetic therapy will be applied for 20 min/session for three days each week for two months. |
| low laser therapy group | Experimental | Other: Low level laser therapy (LLLT)Participants will receive the descriptive medication by neurologist in addition to low laser therapy. Low laser therapy will be applied for 20 min/session for three days each week for two months. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All participants will between the ages of 25 and 45, will of both sexes (male and female), diabetic type two patients with chronic trigeminal neuralgia, (from three to six months).
- Patients will awake, cooperative, and free of psychiatric issues (as determined by a psychologist) as well as difficulties resulting from orthopaedic or special sensory deficits.
Key exclusion criteria (2 listed)
- Patients will ruled out if they developed TN due to a tumour, herpes zoster, or any other reason other than diabetes, such as significant coagulation dysfunction, cardiopulmonary dysfunction or previous invasive treatment (ethanol, radiofrequency, Gama-knife microvascular decompression, glycerinum injection).
- They will not have a previous disability in the face.
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 |
|---|---|---|
| Electromagnetic therapy.Electromagnetic therapy will be applied for 20 min/ session for (3 days/ week for two months) to the group intervention. | Other | electromagnetic group |
| Low level laser therapy (LLLT)Low level laser therapy (LLLT) will be applied for 20 min/session laser scanner for three days each week for two months to the group intervention. | Other | low laser therapy group |
Primary outcome
Studies using electromyography and complex muscle action potentials
Time frame: at the beginning of the study
All patients' compound motor action potential amplitudes in the masseter and temporalis muscles will be evaluated before interventions.
Studies using electromyography and complex muscle action potentials
Time frame: by the end of successful two month of intervention
All patients' compound motor action potential amplitudes in the masseter and temporalis muscles will be evaluated after two month of interventions.
Visual analogue scale (VAS)
Time frame: at the beginning of the study
All the participants were instructed to express their pain by Visual analogue scale (VAS) before the interventions.
Visual analogue scale (VAS)
Time frame: by the end of successful two month of intervention
All the participants were instructed to express their pain by Visual analogue scale (VAS) after two month of interventions.
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 16 Mar 2022.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be available to other researchers after 12 month from publishing.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromagnetic therapy. and Low level laser therapy (LLLT) in people with Trigeminal Neuralgia, run by Delta University for Science and Technology 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 2 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 16 Mar 2022. 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?
Studies using electromyography and complex muscle action potentials (time frame: at the beginning of the study). The study lists 4 primary outcomes in all. 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 16 Mar 2022.