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

Trigeminal Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06440356
• Other study ID #: UGaziantep1986
• Status: Completed
• Phase: N/A
• Start date: January 23, 2024
• Est. completion date: March 30, 2024

Study information

• Verified date: May 2024
• Source: University of Gaziantep
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Intervention

Other:
• laser therapy
low level laser therapy applied

Locations

Country	Name	City	State
Turkey	Irem Karagözoglu	Sehi?tkami?l	Gazi?antep

Sponsors (1)

Lead Sponsor	Collaborator
University of Gaziantep

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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