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

Effect of Non-invasive Photobiomodulation Therapies in Patients With Trigeminal Neuralgia: A Randomised, Placebo-controlled Trial

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).

Study Overview

• Status: Completed
• Conditions: Trigeminal Neuralgia
• Intervention / Treatment: Other: laser therapy

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Gazi̇antep
    • Şehi̇tkami̇l, Gazi̇antep, Turkey, 27310
      • İrem Karagözoğlu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Other: laser therapy; low level laser therapy applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	baseline and week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline and week 4

Collaborators and Investigators

• Sponsor: University of Gaziantep

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2024
• Primary Completion (Actual): March 30, 2024
• Study Completion (Actual): March 30, 2024

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: May 27, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2024
• Last Update Submitted That Met QC Criteria: May 27, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Facial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Neuralgia; Trigeminal Neuralgia
• Other Study ID Numbers: UGaziantep1986

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No