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NCT Number: NCT06440356

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

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).

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İrem Karagözoğlu

Şehitkamil, Gazi̇antep, 27310, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LASER Therapy

Other

low level laser therapy applied

Primary outcomes

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

    Time frame: baseline and 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

  2. Change from baseline in interference in general activities on the 10 point Brief Pain Inventory-facial scale at week 4.

    Time frame: baseline and 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

Secondary outcomes

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

    Time frame: baseline and 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

Sponsors and collaborators

Lead sponsor

University of Gaziantep

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 3, 2024
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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