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

NCT06440356 | Completed

• 1 other identifier: UGaziantep1986
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

Trigeminal Neuralgia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Study Arms (1)

Treatment protocol

EXPERIMENTAL

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

Interventions

laser therapy OTHER

low level laser therapy applied

Treatment protocol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Gaziantep: lead

Study Sites (1)

İrem Karagözoğlu

Şehitkamil, Gazi̇antep, 27310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: June 3, 2024
• Study Start: January 23, 2024
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)