Trigeminal NeuralgiaNCT07590414
High-intensity Laser Therapy Versus Low Level Laser Therapy in the Treatment of Trigeminal Neuralgia
A study testing 1064 nm Nd-YAG Laser and 940 nm Diode laser in people with Trigeminal Neuralgia, run by Alexandria University at 1 site in Egypt.
Trial summary
Trigeminal neuralgia (TN) is the most common and severe type of neuropathic pain disorder affecting the orofacial region. It is characterized by sudden, intense, episodic attacks of pain in the distribution of trigeminal nerve, usually unilateral. The condition severely impairs patient's quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- 1064 nm Nd-YAG Laser and 940 nm Diode laser
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with trigeminal neuralgia according to the International Classification of Headache Disorders (ICHD-3) diagnostic criteria.
- Patients with drug refractory trigeminal neuralgia (defined as poor response to adequate pharmacological treatment or intolerance to side effects for at least three months).
- Patients who are contraindicated for surgical intervention or any other interventions, or who have previously undergone such interventions without obtaining satisfactory pain relief.
Who cannot join
- patients with secondary trigeminal neuralgia diagnosed with brain lesions that is indicated for surgery (percutaneous procedures, gamma knife, microvascular decompression).
- Patients with other orofacial conditions such as temporomandibular disorders, migraine, or other neurological diseases.
- Patients with contraindications to laser use (e.g., pacemakers).
- Patients who are responding well to medical treatment.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria
Faculty of Dentistry, (203) 4868308
Ekhlas Abdalrahman, BDS
About this study
Official title: High-intensity Laser Therapy Versus Low Level Laser Therapy in the Treatment of Trigeminal Neuralgia (a Randomized Clinical Trial)
Trigeminal neuralgia (TN) is the most common and severe type of neuropathic pain disorder affecting the orofacial region. It is characterized by sudden, intense, episodic attacks of pain in the distribution of trigeminal nerve, usually unilateral. The condition severely impairs patient's quality of life. TN represents a diagnostic and therapeutic challenge, pharmacological therapy remains the first-line management, and many patients experience reduced drug tolerance or significant side effects over time. Surgical options are considered for refractory cases but are invasive and carry risks such as infection, nerve damage, and recurrence of symptoms. In recent years, laser based therapies have gained attention as safe, non-invasive alternatives. Low level laser therapy (LLLT) promotes photo-biomodulation and nerve repair without thermal damage, while high-intensity laser therapy (HILT) can achieve deeper penetration and direct neuromodulation. However, comparative evidence regarding their efficacy in TN is still limited. Aim: The present study aims to evaluate and compare the effect of High intensity laser therapy and low level laser therapy in reducing pain intensity and improving quality of life in patients with trigeminal neuralgia.
- Conditions
- Trigeminal Neuralgia
- Being tested
- 1064 nm Nd-YAG Laser, 940 nm Diode laser
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1064 nm Nd-YAG LaserOther
This group will receive twelve sessions of High-intensity laser therapy (HILT) using using 1064nm Nd:YAG laser in Piano mode using a Fotona LightWalker® , with three session per week
940 nm Diode laserOther
This group will recive twelve sessions of Low Level Laser Therapy (LLLT) using (940 nm Diode laser epicX manfactured by Biolase. The deep tissue handpice (30 mm diameter) will be used, with three session per week
| Study group | Role | What they receive |
|---|---|---|
| Nd-YAG Laser | Experimental | Not described Receives: Other: 1064 nm Nd-YAG Laser |
| Diode laser | Experimental | Not described Receives: Other: 940 nm Diode laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain scores
Subjective Pain score as measured by Numerical Rating Scale (NRS) [26]
. Pain will be measured at baseline and at weeks 1, 2, 3, 4, 8, and 12
Measured: up to 12 weeks
Change in quality of life
it will be assessed using OHIP-14 questionnaire at baseline, and 4, 8, 12 weeks.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start15 May 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590414
- Sponsor's protocol ID
- 1159-10-25
- Status last verified
- May 2026
- First submitted
- 10 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-intensity Laser Therapy Versus Low Level Laser Therapy in the Treatment of Trigeminal Neuralgia (a Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07590414
- Acronym / sponsor ID
- 1159-10-25
- Conditions
- Trigeminal Neuralgia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 15 May 2026 (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) is the most common and severe type of neuropathic pain disorder affecting the orofacial region. It is characterized by sudden, intense, episodic attacks of pain in the distribution of trigeminal nerve, usually unilateral. The condition severely impairs patient's quality of life. TN represents a diagnostic and therapeutic challenge, pharmacological therapy remains the first-line management, and many patients experience reduced drug tolerance or significant side effects over time. Surgical options are considered for refractory cases but are invasive and carry risks such as infection, nerve damage, and recurrence of symptoms. In recent years, laser based therapies have gained attention as safe, non-invasive alternatives. Low level laser therapy (LLLT) promotes photo-biomodulation and nerve repair without thermal damage, while high-intensity laser therapy (HILT) can achieve deeper penetration and direct neuromodulation. However, comparative evidence regarding their efficacy in TN is still limited. Aim: The present study aims to evaluate and compare the effect of High intensity laser therapy and low level laser therapy in reducing pain intensity and improving quality of life in patients with trigeminal neuralgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nd-YAG Laser | Experimental | Other: 1064 nm Nd-YAG Laser |
| Diode laser | Experimental | Other: 940 nm Diode laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with trigeminal neuralgia according to the International Classification of Headache Disorders (ICHD-3) diagnostic criteria.
- Patients with drug refractory trigeminal neuralgia (defined as poor response to adequate pharmacological treatment or intolerance to side effects for at least three months).
- Patients who are contraindicated for surgical intervention or any other interventions, or who have previously undergone such interventions without obtaining satisfactory pain relief.
Key exclusion criteria (5 listed)
- patients with secondary trigeminal neuralgia diagnosed with brain lesions that is indicated for surgery (percutaneous procedures, gamma knife, microvascular decompression).
- Patients with other orofacial conditions such as temporomandibular disorders, migraine, or other neurological diseases.
- Patients with contraindications to laser use (e.g., pacemakers).
- Patients who are responding well to medical treatment.
- Pregnant or lactating women.
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 |
|---|---|---|
| 1064 nm Nd-YAG LaserThis group will receive twelve sessions of High-intensity laser therapy (HILT) using using 1064nm Nd:YAG laser in Piano mode using a Fotona LightWalker® , with three session per week | Other | Nd-YAG Laser |
| 940 nm Diode laserThis group will recive twelve sessions of Low Level Laser Therapy (LLLT) using (940 nm Diode laser epicX manfactured by Biolase. The deep tissue handpice (30 mm diameter) will be used, with three session per week | Other | Diode laser |
Primary outcome
Change in pain scores
Time frame: up to 12 weeks
Subjective Pain score as measured by Numerical Rating Scale (NRS) [26] . Pain will be measured at baseline and at weeks 1, 2, 3, 4, 8, and 12
Change in quality of life
Time frame: up to 12 weeks
it will be assessed using OHIP-14 questionnaire at baseline, and 4, 8, 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1064 nm Nd-YAG Laser and 940 nm Diode laser in people with Trigeminal Neuralgia, run by Alexandria 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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 15 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ekhlas Abdalrahman, BDS (00249110934300, ekhlas.babiker44@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain scores (time frame: up to 12 weeks). The study lists 2 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 15 May 2026; AzTrials last refreshed its copy on 1 Nov 2026.