A Nasal Applicator for the Treatment of Trigeminal Neuralgia

• ClinicalTrials.gov Identifier: NCT01761604
• Recruitment Status: Completed
• First Posted: January 7, 2013
• Last Update Posted: September 14, 2017
• Sponsor: Chicago Anesthesia Pain Specialists
• Information provided by (Responsible Party): Kenneth D Candido, Chicago Anesthesia Pain Specialists

Tracking Information

• First Submitted Date: January 2, 2013
• First Posted Date: January 7, 2013
• Last Update Posted Date: September 14, 2017
• Study Start Date: December 2011
• Actual Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 3, 2013)

Pain intensity numeric rating scale [ Time Frame: Before procedure and after procedure ]

Change in pain intensity before procedure, baseline. And after procedure 15 minutes, 30 minutes, day 1, 7, 14, 21, and 28.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 3, 2013)

Patient's global impression of change [ Time Frame: After procedure ]

Before procedure, baseline. And after procedure 30 minutes, day 1, 7, 14, 21, and 28.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: January 3, 2013)

Modified Brief Pain inventory (short form) [ Time Frame: Before procedure and after procedure ]

Before procedure, baseline. And after procedure day 1, 7, 14, 21, and 28.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: A Nasal Applicator for the Treatment of Trigeminal Neuralgia
• Official Title: The Use of Tx360™ Nasal Applicator for Sphenopalatine Ganglion Block in the Treatment of Trigeminal Neuralgia

Brief Summary

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.

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Trigeminal Neuralgia
• Intervention: Device: Nasal ganglion block for TN

Study Arms

Nasal ganglion block for TN

Sphenopalatine ganglion block using the Tx360™ device

Intervention: Device: Nasal ganglion block for TN

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 3, 2013): 10
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 2017
• Actual Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01761604
• Other Study ID Numbers: Advocate-IRB-5241
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Kenneth D Candido, Chicago Anesthesia Pain Specialists
• Study Sponsor: Chicago Anesthesia Pain Specialists
• Collaborators: Not Provided

Investigators

• Principal Investigator: Kenneth D Candido, M.D.; Chicago Anesthesia Pain Specialists

• PRS Account: Chicago Anesthesia Pain Specialists
• Verification Date: September 2017