Trigeminal Neuralgia
Conditions
Keywords
Trigeminal Neuralgia, SPG block, Tx360, nasal applicator
Brief 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).
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.
Interventions
DEVICESPG block with the use of the Tx360 device
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.
Sponsors
Aretaieio Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male or female * older than 18 years * ASA I or II * trigeminal neuralgia of any etiology
Exclusion criteria
* 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, * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NRS pain score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in the 9 components measured by the SF-36 questionnaire | during the first visit to the clinic and 3 months after the completion of the treatment | 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. |
Countries
Greece
Outcome results
None listed