Clinical trial NCT06440356: Effect of Non-invasive Photobiomodulation Therapies in Patients With Trigeminal Neuralgia
Official title: Effect of Non-invasive Photobiomodulation Therapies in Patients With Trigeminal Neuralgia: A Randomised, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigeminal Neuralgia
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in pain intensity on the 10 point Brief Pain Inventory-facial scale at week 4.
timeFrame: baseline and week 4
measure: Change from baseline in interference in general activities on the 10 point Brief Pain Inventory-facial scale at week 4.
timeFrame: baseline and week 4
Secondary outcomes:
measure: Change from baseline in interference in face specific activities on the 10 point Brief Pain Inventory-facial scale at week 4.
timeFrame: baseline and week 4
Other outcomes:
Locations:
city: Şehi̇tkami̇l
country: Turkey
facility: İrem Karagözoğlu
state: Gazi̇antep
Study officials:
References: