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

NCT ID: NCT06440356

Last Updated: 2024-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-23
• Study Completion Date: 2024-03-30

Brief Summary

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).

Detailed Description

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.

Conditions

Trigeminal Neuralgia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment protocol

In the first group, a NGD laser with dual wavelength, infrared and LED features, operating at a depth of 50 mm, which can be applied regionally, was used.

In the second group, a neodymium-doped yttrium aluminium garnet laser was used. After the laser unit has been switched on, the LLLT preset has been selected.

Patients in the third group received emission-free laser treatment. In the same procedure with the Nd:YAG laser, a placebo treatment was performed with the device on, laser beams visible but not active.

Group Type: EXPERIMENTAL

laser therapy

Intervention Type: OTHER

low level laser therapy applied

Interventions

laser therapy

low level laser therapy applied

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Gaziantep

OTHER

Sponsor Role: lead

Responsible Party

İREM KARAGOZOGLU

Assist. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

İrem Karagözoğlu

Şehitkamil, Gazi̇antep, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

UGaziantep1986

Identifier Type: -

Identifier Source: org_study_id