A Nasal Applicator for the Treatment of Trigeminal Neuralgia
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Purpose
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 Tx360™, 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.
| Condition | Intervention |
|---|---|
|
Trigeminal Neuralgia |
Device: Nasal ganglion block for TN |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Use of Tx360™ Nasal Applicator for Sphenopalatine Ganglion Block in the Treatment of Trigeminal Neuralgia |
- Pain intensity numeric rating scale [ Time Frame: Before procedure and after procedure ] [ Designated as safety issue: No ]Change in pain intensity before procedure, baseline. And after procedure 15 minutes, 30 minutes, day 1, 7, 14, 21, and 28.
- Patient's global impression of change [ Time Frame: After procedure ] [ Designated as safety issue: No ]Before procedure, baseline. And after procedure 30 minutes, day 1, 7, 14, 21, and 28.
- Modified Brief Pain inventory (short form) [ Time Frame: Before procedure and after procedure ] [ Designated as safety issue: No ]Before procedure, baseline. And after procedure day 1, 7, 14, 21, and 28.
| Estimated Enrollment: | 10 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Nasal ganglion block for TN
Sphenopalatine ganglion block using the Tx360™ device
|
Device: Nasal ganglion block for TN |
Detailed Description:
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 Tx360™, a new nasal applicator device, in the treatment of TN. The Tx360™ 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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18- 80 years old
- Trigeminal Neuralgia
Exclusion Criteria:
- Nasal septal deformity such as: cleft lip and palate, choanal atresia
- Septal perforation
- Recent nasal/midface trauma (< 3 months)
- Bleeding disorder such as Von Willebrand's disease or hemophilia
- Severe respiratory distress
- Neoplasm such as the following: Angiofibroma, sinus Tumors, Granuloma
- Congestion has been present more than 10 days, fever (define as temperature≥ 100.4 F)
- Current cocaine user
- Skin around and inside the nasal passage is dry, cracked, oozing, or bleeding
- Allergy to marcaine
- Pregnancy
Contacts and Locations| Contact: N. Nick Knezevic, M.D., Ph. D. | 773-296-7927 | aimmc.anesthesia.research@gmail.com |
| United States, Illinois | |
| Chicago Anesthesia Pain Specialists | Recruiting |
| Chicago, Illinois, United States, 60657 | |
| Contact: N. Nick Knezevic, M.D., Ph.D. 773-296-7927 aimmc.anesthesia.research@gmail.com | |
| Principal Investigator: Kenneth D Candido, MD | |
| Principal Investigator: | Kenneth D Candido, M.D. | Chicago Anesthesia Pain Specialists |
More Information
No publications provided
| Responsible Party: | Kenneth D Candido, Chairman of the Anesthesia Department at Advocate Illinois Masonic Medical Center, Chicago Anesthesia Pain Specialists |
| ClinicalTrials.gov Identifier: | NCT01761604 History of Changes |
| Other Study ID Numbers: | Advocate-IRB-5241 |
| Study First Received: | January 2, 2013 |
| Last Updated: | January 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neuralgia Trigeminal Neuralgia Pain Neurologic Manifestations Nervous System Diseases |
Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Trigeminal Nerve Diseases Cranial Nerve Diseases |
ClinicalTrials.gov processed this record on May 21, 2013