A Nasal Applicator for the Treatment of Trigeminal Neuralgia

NCT01761604 | Completed

• 1 other identifier: Advocate-IRB-5241
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Trigeminal Neuralgia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Patient's global impression of change

  After procedure

Other Outcomes (1)

• Modified Brief Pain inventory (short form)

  Before procedure and after procedure

Study Arms (1)

Nasal ganglion block for TN

OTHER

Sphenopalatine ganglion block using the Tx360™ device

Device: Nasal ganglion block for TN

Interventions

Nasal ganglion block for TN DEVICE

Nasal ganglion block for TN

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Trigeminal Neuralgia

You may not qualify if:

• 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

Sponsors & Collaborators

• Chicago Anesthesia Pain Specialists: lead

Study Sites (1)

Chicago Anesthesia Pain Specialists

Chicago, Illinois, 60657, United States

Location

MeSH Terms

Conditions

Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Kenneth D Candido, M.D.

  Chicago Anesthesia Pain Specialists

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of the Anesthesia Department at Advocate Illinois Masonic Medical Center

Study Record Dates

• First Submitted: January 2, 2013
• First Posted: January 7, 2013
• Study Start: December 1, 2011
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 14, 2017

Record last verified: 2017-09

Locations

US (1)