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

NCT07590414 | Not Yet Recruiting

• 1 other identifier: 1159-10-25
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trigeminal Neuralgia

Outcome Measures

Primary Outcomes (2)

• 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

  up to 12 weeks

• Change in quality of life

  it will be assessed using OHIP-14 questionnaire at baseline, and 4, 8, 12 weeks.

  up to 12 weeks

Study Arms (2)

Nd-YAG Laser

EXPERIMENTAL

Other: 1064 nm Nd-YAG Laser

Diode laser

EXPERIMENTAL

Other: 940 nm Diode laser

Interventions

1064 nm Nd-YAG Laser OTHER

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

Nd-YAG Laser

940 nm Diode laser OTHER

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

Diode laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

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

Alexandria, Egypt

Location

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Lasers, Solid-State; Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Central Study Contacts

Ekhlas Abdalrahman, BDS

CONTACT

00249110934300; ekhlas.babiker44@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: May 15, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

EG (1)