Trigeminal NeuralgiaNCT06663410
Sphenopalatine Ganglion Block with Tx360 for Trigeminal Neuralgia
An observational study of Trigeminal Neuralgia, run by Aretaieio Hospital at 1 site in Greece.
Trial summary
The aim of this study was to investigate the effect of sphenopalatine ganglion (SPG) block bilaterally through a nasal device called Tx360 by delivering 0.3cc of lidocaine 2% for pain relief in patients with Trigeminal Neuralgia (TN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- SPG block with the use of the Tx360 device
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteGreece
- Study dates
- 28 Feb 2021to 15 Apr 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients of both sexes, ASA I or II, with classical or atypical, V2 (maxillary branch) or V3 (mandibular branch) trigeminal neuralgia, partly or completely drug-resistant, with NRS = 8-9, under pharmaceutical treatment, with minimal or no clinical improvement and/or poor patient satisfaction. A written informed consent was obtained from each eligible patient.
Who may be able to join
- male or female
- older than 18 years
- ASA I or II
- trigeminal neuralgia of any etiology
Who cannot join
- anatomical abnormalities of the nasal septum,
- rhinitis or nasal inflammation due to medication,
- nasal septum perforation,
- nasal or paranasal sinus surgery (within the last 3 months)
- dryness or irritation of the nasal mucosa, localized pain, nasal discharge, or bleeding from the nose,
- disorders related to bleeding or coagulation,
Show all 10Show fewer
- significant respiratory distress,
- presence of malignancies, including angiofibroma or other tumors of the paranasal sinuses, or granulomas,
- persistent nasal congestion lasting more than 10 days, accompanied by high fever, discolored nasal mucosa, or facial pain and headaches,
- nasal or skull fractures occurring within the last 3 months
Trial locations and contacts
1 site in 1 country.
Greece1 site
Aretaieio Hospital, National and Kapodistrian University of Athens
Athens, 11528
About this study
Official title: Sphenopalatine Ganglion Block with Tx360 Nasal Applicator for Trigeminal Neuralgia: a Prospective Observational Study
The aim of this study was to investigate the effect of sphenopalatine ganglion (SPG) block bilaterally through a nasal device called Tx360 by delivering 0.3cc of lidocaine 2% for pain relief in patients with Trigeminal Neuralgia (TN).
Read the detailed description
Trigeminal neuralgia (TN) is a chronic condition that causes sudden, intense facial pain that has a severe impact on patients' life quality and everyday functioning. Even with many treatments available, some patients still struggle to manage their pain effectively.
Sphenopalatine ganglion (SPG) block, delivered through a recently introduced nasal applicator called Tx360, has shown promising results for those patients suffering persistent facial pain, icluding cases of TN.
The purpose of this study was to observe how effective the SPG block delivering lidocaine 2% via the Tx360 is for pain relief in patients with TN. The patients' diagnosis included classical or atypical TN affecting the V2 (maxillary) or V3 (mandibular) branches, with partial or complete resistance to medication.
Researchers measured pain levels using the Numerical Rating Scale (NRS) and evaluated the effects of treatment on patients' physical and mental wellbeing using the Short Form-36 (SF-36) Quality of Life Questionnaire.
- Conditions
- Trigeminal Neuralgia
- Being tested
- SPG block with the use of the Tx360 device
- Keywords
- Trigeminal Neuralgia, SPG block, Tx360, nasal applicator
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPG block with the use of the Tx360 deviceDevice
A SPG block was performed using the Tx360 nasal applicator according to the manufacturer's instructions bilaterally, injecting 0.3cc of lidocaine 2% into each nostril.
| Study group | Role | What they receive |
|---|---|---|
| Fifteen patients of both sexes, older than 18 years, ASA I or II, TN of any etiology | Patients will undergo bilateral sphenopalatine ganglion block with Tx360 nasal applicator using 0.3cc lidocaine 2% in each side, once every week, for a 6-week period. Receives: Device: SPG block with the use of the Tx360 device |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS pain score
Outcome measures were assessed on a weekly basis for the initial 6-week treatment period, that is at every visit where SPG block would be administered, and on a monthly basis for the subsequent 12-week follow-up period, where patients participated in scheduled monthly follow-up calls.
Patients were instructed to maintain a detailed pain diary for these 18 weeks and were asked about their pain intensity as measured with the Numerical Rating Scale (NRS) scoring system.
NRS consists of a simple 11-point scale from zero to ten, where zero corresponds to non-existent pain and ten corresponds to the worst possible pain the patient has ever experienced. Patients choose the number that best corresponds to the intensity of their pain.
Measured: From enrollment to the end of the follow-up period, which included an initial 6-week period, where the treatment was being administered, and a subsequent 12-week period post-treatment that served for follow-up purposes.
Secondary outcomes (1)
changes in the 9 components measured by the SF-36 questionnaire
The SF-36 Quality of Life Questionnaire consists of 36 closed-ended questions, with 2-5 ratings in the answers. Each question contributes to a total score ranging from 0 to 100, measuring both mental and physical health status. This questionnaire is appropriate for self-completion as well as for completion during a telephone or a face-to-face interview, provided that the participant is over 14 years old.
During the patients' first clinic appointment, they were asked to complete the SF-36 Questionnaire to assess the impact of trigeminal neuralgia on their daily functioning. Three months after the treatment was completed, we conducted a follow-up assessment using the same questionnaire in order to evaluate any changes in the nine components of the SF-36 questionnaire: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general health, and perceived health change.
Measured: during the first visit to the clinic and 3 months after the completion of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start28 Feb 2021
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aretaieio Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Orfanou, Aretaieio Hospital
- Investigators
- Athanasia Tsaroucha, Assoc. Prof., Study director, Aretaieio Hospital, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663410
- Sponsor's protocol ID
- 274/12-11-2020
- Other IDs
- Aretaieio Hospital
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cady R, Saper J, Dexter K, Manley HR. A double-blind, placebo-controlled study of repetitive transnasal sphenopalatine ganglion blockade with tx360((R)) as acute treatment for chronic migraine. Headache. 2015 Jan;55(1):101-16. doi: 10.1111/head.12458. Epub 2014 Oct 23.
PubMed 25338927Candido KD, Massey ST, Sauer R, Darabad RR, Knezevic NN. A novel revision to the classical transnasal topical sphenopalatine ganglion block for the treatment of headache and facial pain. Pain Physician. 2013 Nov-Dec;16(6):E769-78.
PubMed 24284858Ho KWD, Przkora R, Kumar S. Sphenopalatine ganglion: block, radiofrequency ablation and neurostimulation - a systematic review. J Headache Pain. 2017 Dec 28;18(1):118. doi: 10.1186/s10194-017-0826-y.
PubMed 29285576Piagkou M, Demesticha T, Troupis T, Vlasis K, Skandalakis P, Makri A, Mazarakis A, Lappas D, Piagkos G, Johnson EO. The pterygopalatine ganglion and its role in various pain syndromes: from anatomy to clinical practice. Pain Pract. 2012 Jun;12(5):399-412. doi: 10.1111/j.1533-2500.2011.00507.x. Epub 2011 Sep 29.
PubMed 21956040
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sphenopalatine Ganglion Block with Tx360 Nasal Applicator for Trigeminal Neuralgia: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06663410
- Acronym / sponsor ID
- 274/12-11-2020
- Conditions
- Trigeminal Neuralgia
- Keywords
- Trigeminal Neuralgia, SPG block, Tx360, nasal applicator
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Aretaieio HospitalUniversity, hospital or other
- Study start
- 28 Feb 2021 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 29 Oct 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 investigate the effect of sphenopalatine ganglion (SPG) block bilaterally through a nasal device called Tx360 by delivering 0.3cc of lidocaine 2% for pain relief in patients with Trigeminal Neuralgia (TN).
Detailed description
Trigeminal neuralgia (TN) is a chronic condition that causes sudden, intense facial pain that has a severe impact on patients' life quality and everyday functioning. Even with many treatments available, some patients still struggle to manage their pain effectively.
Sphenopalatine ganglion (SPG) block, delivered through a recently introduced nasal applicator called Tx360, has shown promising results for those patients suffering persistent facial pain, icluding cases of TN.
The purpose of this study was to observe how effective the SPG block delivering lidocaine 2% via the Tx360 is for pain relief in patients with TN. The patients' diagnosis included classical or atypical TN affecting the V2 (maxillary) or V3 (mandibular) branches, with partial or complete resistance to medication.
Researchers measured pain levels using the Numerical Rating Scale (NRS) and evaluated the effects of treatment on patients' physical and mental wellbeing using the Short Form-36 (SF-36) Quality of Life Questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fifteen patients of both sexes, older than 18 years, ASA I or II, TN of any etiology | – | Device: SPG block with the use of the Tx360 devicePatients will undergo bilateral sphenopalatine ganglion block with Tx360 nasal applicator using 0.3cc lidocaine 2% in each side, once every week, for a 6-week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients of both sexes, ASA I or II, with classical or atypical, V2 (maxillary branch) or V3 (mandibular branch) trigeminal neuralgia, partly or completely drug-resistant, with NRS = 8-9, under pharmaceutical treatment, with minimal or no clinical improvement and/or poor patient satisfaction. A written informed consent was obtained from each eligible patient.
Key inclusion criteria (4 listed)
- male or female
- older than 18 years
- ASA I or II
- trigeminal neuralgia of any etiology
Key exclusion criteria (10 listed)
- anatomical abnormalities of the nasal septum,
- rhinitis or nasal inflammation due to medication,
- nasal septum perforation,
- nasal or paranasal sinus surgery (within the last 3 months)
- dryness or irritation of the nasal mucosa, localized pain, nasal discharge, or bleeding from the nose,
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 |
|---|---|---|
| SPG block with the use of the Tx360 deviceA SPG block was performed using the Tx360 nasal applicator according to the manufacturer's instructions bilaterally, injecting 0.3cc of lidocaine 2% into each nostril. | Device | Fifteen patients of both sexes, older than 18 years, ASA I or II, TN of any etiology |
Primary outcome
NRS pain score
Time frame: From enrollment to the end of the follow-up period, which included an initial 6-week period, where the treatment was being administered, and a subsequent 12-week period post-treatment that served for follow-up purposes.
Outcome measures were assessed on a weekly basis for the initial 6-week treatment period, that is at every visit where SPG block would be administered, and on a monthly basis for the subsequent 12-week follow-up period, where patients participated in scheduled monthly follow-up calls. Patients were instructed to maintain a detailed pain diary for these 18 weeks and were asked about their pain intensity as measured with the Numerical Rating Scale (NRS) scoring system. NRS consists of a simple 11-point scale from zero to ten, where zero corresponds to non-existent pain and ten corresponds to the worst possible pain the patient has ever experienced. Patients choose the number that best corresponds to the intensity of their pain.
1 secondary outcome
changes in the 9 components measured by the SF-36 questionnaire
Time frame: during the first visit to the clinic and 3 months after the completion of the treatment
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 29 Oct 2024.
- Background: PubMed 25338927Cady R, Saper J, Dexter K, Manley HR. A double-blind, placebo-controlled study of repetitive transnasal sphenopalatine ganglion blockade with tx360((R)) as acute treatment for chronic migraine. Headache. 2015 Jan;55(1):101-16. doi: 10.1111/head.12458. Epub 2014 Oct 23.
- Background: PubMed 24284858Candido KD, Massey ST, Sauer R, Darabad RR, Knezevic NN. A novel revision to the classical transnasal topical sphenopalatine ganglion block for the treatment of headache and facial pain. Pain Physician. 2013 Nov-Dec;16(6):E769-78.
- Background: PubMed 29285576Ho KWD, Przkora R, Kumar S. Sphenopalatine ganglion: block, radiofrequency ablation and neurostimulation - a systematic review. J Headache Pain. 2017 Dec 28;18(1):118. doi: 10.1186/s10194-017-0826-y.
- Background: PubMed 21956040Piagkou M, Demesticha T, Troupis T, Vlasis K, Skandalakis P, Makri A, Mazarakis A, Lappas D, Piagkos G, Johnson EO. The pterygopalatine ganglion and its role in various pain syndromes: from anatomy to clinical practice. Pain Pract. 2012 Jun;12(5):399-412. doi: 10.1111/j.1533-2500.2011.00507.x. Epub 2011 Sep 29.
- Individual participant dataSharing planned: Undecided
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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.
Athanasia Tsaroucha, Assoc. Prof. study director
Aretaieio Hospital, National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trigeminal Neuralgia, run by Aretaieio Hospital at 1 site in Greece.
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 4 inclusion and 10 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 29 Oct 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 Greece. 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?
NRS pain score (time frame: From enrollment to the end of the follow-up period, which included an initial 6-week period, where the treatment was being administered, and a subsequent 12-week period post-treatment that served for follow-up purposes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06663410, which also lists 4 linked publications.
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 29 Oct 2024.