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

Not Applicable

Completed

• Conditions: Trigeminal Neuralgia
• Interventions: Other: laser therapy

• Registration Number: NCT06440356
• Lead Sponsor: University of Gaziantep

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.

Study Timeline

• Study Start: 2024-01-23
• Primary Completion: 2024-03-30
• Study Completion: 2024-03-30
• Status Verified: 2024-05
• Study First Submitted: 2024-05-21
• Study First Submitted QC: 2024-05-27
• Last Update Submitted: 2024-05-27
• Study First Posted: 2024-06-03
• Last Update Posted: 2024-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment protocol	laser therapy	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in pain intensity on the 10 point Brief Pain Inventory-facial scale at week 4.	baseline and 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
Change from baseline in interference in general activities on the 10 point Brief Pain Inventory-facial scale at week 4.	baseline and 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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

İrem Karagözoğlu; 🇹🇷 Şehi̇tkami̇l, Gazi̇antep, Turkey