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The pain from Trigeminal Neuralgia (TN) imposes a substantial burden on patients in daily function and reduces quality of life. The sphenopalatine ganglion, located in the posterior part of the middle nasal turbinate, is involved in the pain associated to TN, by blocking the sphenopalatine ganglion relieves patients from the symptoms. However, methods currently in use to accomplish this are either cumbersome for the patient or invasive regarding the puncture of structures.
The purpose of this study is to evaluate the efficacy of Tx360â„¢, a new nasal applicator device, in the treatment of TN. A local anesthetic will be delivered on the ganglion area. We are expecting that this new device will provide at least the same pain relief as the previously described approaches. However, this nasal applicator is intended to be an easy and non invasive method for office use.
The pain from Trigeminal Neuralgia (TN) imposes a substantial burden on patients in daily function and reduces quality of life. Pain severity correlates with reduced measures of daily functioning, and overall health status.
The sphenopalatine ganglion, located in the posterior part of the middle nasal turbinate, is involved in the pain associated to TN, by blocking the sphenopalatine ganglion relieves patients from the symptoms. However, methods currently in use to accomplish this are either cumbersome for the patient or invasive regarding the puncture of structures.
The purpose of this study is to evaluate the efficacy of Tx360â„¢, a new nasal applicator device, in the treatment of TN. The Tx360â„¢ is a single use nasal applicator that can reach the sphenopalatine ganglion area. It is designed to dispense medications through a flexible canula.
The patients with TN will receive a 0.5 mL spray of local anesthetic on the ganglion area, and measure the change in pain intensity and quality of life.
We are expecting that this new device will provide at least the same pain relief as the previously described approaches. However, this nasal applicator is intended to be an easy and non invasive method for office use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal ganglion block for TN | Other | Sphenopalatine ganglion block using the Tx360â„¢ device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal ganglion block for TN | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity numeric rating scale | Change in pain intensity before procedure, baseline. And after procedure 15 minutes, 30 minutes, day 1, 7, 14, 21, and 28. | Before procedure and after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's global impression of change | Before procedure, baseline. And after procedure 30 minutes, day 1, 7, 14, 21, and 28. | After procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Brief Pain inventory (short form) | Before procedure, baseline. And after procedure day 1, 7, 14, 21, and 28. | Before procedure and after procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth D Candido, M.D. | Chicago Anesthesia Pain Specialists | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chicago Anesthesia Pain Specialists | Chicago | Illinois | 60657 | United States |
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| ID | Term |
|---|---|
| D014277 | Trigeminal Neuralgia |
| ID | Term |
|---|---|
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
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| D009057 |
| Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |