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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06440356
Enrollment
45
Registered
2024-06-03
Start date
2024-01-23
Completion date
2024-03-30
Last updated
2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trigeminal Neuralgia

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.

Interventions

OTHERlaser therapy

low level laser therapy applied

Sponsors

University of Gaziantep
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in pain intensity on the 10 point Brief Pain Inventory-facial scale at week 4.baseline and week 4Brief 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 4Brief 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

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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026