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

Официальное название

High-intensity Laser Therapy Versus Low Level Laser Therapy in the Treatment of Trigeminal Neuralgia (a Randomized Clinical Trial)

Обзор

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.

Вмешательства

• Другое 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
• Другое 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

Первичные конечные точки

• Change in pain scores [Срок оценки: up to 12 weeks]
• Change in quality of life [Срок оценки: up to 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University — Alexandria

Идентификаторы

NCT: NCT07590414 · 1159-10-25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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