Trigeminal NeuralgiaNCT06440356
Effect of Non-invasive Photobiomodulation Therapies in Patients With Trigeminal Neuralgia
A study testing laser therapy in people with Trigeminal Neuralgia, run by University of Gaziantep at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- laser therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jan 2024to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İrem Karagözoğlu
Şehitkamil, Gazi̇antep, 27310
About this study
Official title: Effect of Non-invasive Photobiomodulation Therapies in Patients With Trigeminal Neuralgia: A Randomised, Placebo-controlled Trial
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).
Read the 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.
- Conditions
- Trigeminal Neuralgia
- Being tested
- laser therapy
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser therapyOther
low level laser therapy applied
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
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
Measured: baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start23 Jan 2024
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İREM KARAGOZOGLU, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440356
- Sponsor's protocol ID
- UGaziantep1986
- Status last verified
- May 2024
- First submitted
- 21 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-invasive Photobiomodulation Therapies in Patients With Trigeminal Neuralgia: A Randomised, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06440356
- Acronym / sponsor ID
- UGaziantep1986
- Conditions
- Trigeminal Neuralgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment protocol | Experimental | Other: laser therapyIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- • Patients diagnosed with type 2 (atypical, symptomatic) trigeminal neuralgia as defined by the International Headache Society (2).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laser therapylow level laser therapy applied | Other | Treatment protocol |
Primary outcome
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
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser therapy in people with Trigeminal Neuralgia, run by University of Gaziantep at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in pain intensity on the 10 point Brief Pain Inventory-facial scale at week 4. (time frame: baseline and week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.