Effect of Non-invasive Photobiomodulation Therapies in Patients With Trigeminal Neuralgia

University of Gaziantep45 enrolled

Overview

The aim of this study was to compare the effectiveness of two different photobiomodulation (PBM) therapies as an alternative to medical treatment to reduce pain and improve quality of life in patients with trigeminal neuralgia (TN). A total of 45 patients with mean age of 46.09 years (26 female, 19 male) were randomly divided into three groups. The first group received PBM therapy with a new generation diode laser (NGD laser). In the second group, low-level Nd:YAG laser was applied along the affected nerve line and the placebo group received the same protocol with Nd:YAG laser without the device switched on. The scores were recorded before and after the treatment using the Brief Pain Inventory-facial (BPI-facial) scale.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Trigeminal Neuralgia

Interventions

laser therapyOTHER

low level laser therapy applied

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients diagnosed with idiopathic trigeminal neuralgia as defined by the International Headache Society (2). * Patients diagnosed with idiopathic trigeminal neuralgia and receiving medical treatment (carbamazepine, etc.) * Patients with unilateral, severe, sudden onset of facial pain along the branches of the trigeminal nerve. * Patients who have not previously received any interventional treatment for TN. * Patients recently diagnosed and started on a first dose of carbamazepine and its derivatives Exclusion Criteria: * • Patients diagnosed with type 2 (atypical, symptomatic) trigeminal neuralgia as defined by the International Headache Society (2). * Patients with etiologies such as tumour, multiple sclerosis or neurovascular compression on radiography. * Pregnant women * Patients with systemic diseases such as diabetes, cardiovascular disease, hypertension, etc. * Patients who have been previously diagnosed and treated with any type of TN therapy.

Locations (1)

İrem Karagözoğlu

Şehitkamil, Gazi̇antep, Turkey (Türkiye)

Outcomes

Primary Outcomes

Change from baseline in pain intensity on the 10 point Brief Pain Inventory-facial scale at week 4.

Brief Pain Inventory-facial scale is a validated, self-reported scale assessing the average pain intensity over the past 24 hour period. The scores range from 0: no pain, 10: the worst pain you can imagine change= week 4 score-baseline score

Time frame: baseline and week 4

Change from baseline in interference in general activities on the 10 point Brief Pain Inventory-facial scale at week 4.

Brief Pain Inventory-facial scale is a validated, self-reported scale assessing the interference in general activities over the past 24 hour period. The scores range from 0: no inhibition, 10: complete inhibition change= week 4 score-baseline score

Time frame: baseline and week 4

Secondary Outcomes

Change from baseline in interference in face specific activities on the 10 point Brief Pain Inventory-facial scale at week 4.

Brief Pain Inventory-facial scale is a validated, self-reported scale assessing the interference in face specific activities over the past 24 hour period. The scores range from 0: no inhibition, 10: complete inhibition change= week 4 score-baseline score

Time frame: baseline and week 4

Data from ClinicalTrials.gov

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