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Clinical Trials in Egypt / NCT07590414
Starting soon Not applicable

High-intensity Laser Therapy Versus Low Level Laser Therapy in the Treatment of Trigeminal Neuralgia

NCT07590414 · tracked via the Priya Life Science Egypt tracker
Sponsor
Alexandria University
Phase
Not applicable
Started
2026-05-15
Last updated
2026-05-15

Condition(s) studied

Trigeminal Neuralgia

Investigational drug(s) / intervention(s)

1064 nm Nd-YAG Laser940 nm Diode laser

1064 nm Nd-YAG Laser: 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 laser: 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 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. 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Change in pain scores — 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 — up to 12 weeks
    it will be assessed using OHIP-14 questionnaire at baseline, and 4, 8, 12 weeks.

Trial sites (1)

FacilityCityRegionStatus
Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt Alexandria Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07590414 on ClinicalTrials.gov ↗ ← All trials in Egypt