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A Nasal Applicator for the Treatment of Trigeminal Neuralgia

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

Tracking Information
First Submitted Date  ICMJE January 2, 2013
First Posted Date  ICMJE January 7, 2013
Last Update Posted Date September 14, 2017
Study Start Date  ICMJE December 2011
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE 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  ICMJE A Nasal Applicator for the Treatment of Trigeminal Neuralgia
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Trigeminal Neuralgia
Intervention  ICMJE Device: Nasal ganglion block for TN
Study Arms  ICMJE Nasal ganglion block for TN
Sphenopalatine ganglion block using the Tx360™ device
Intervention: Device: Nasal ganglion block for TN
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2013)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01761604
Other Study ID Numbers  ICMJE Advocate-IRB-5241
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kenneth D Candido, Chicago Anesthesia Pain Specialists
Study Sponsor  ICMJE Chicago Anesthesia Pain Specialists
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kenneth D Candido, M.D. Chicago Anesthesia Pain Specialists
PRS Account Chicago Anesthesia Pain Specialists
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP