Use of the Tx360 Nasal Applicator in the Treatment of Chronic Migraine
Status:
Completed
Trial end date:
2014-02-01
Target enrollment:
Participant gender:
Summary
Migraine imposes a substantial burden on patients in terms of diminished daily functioning,
quality of life, and financial loss. Pain severity and duration correlates with reduced
measures of daily functioning, and overall health status. The sphenopalatine ganglion (SPG)
has been implicated in a variety of cephalalgias. This has been well represented in the
literature dating back over a century. Access to this structure can be gained via a small
area of mucosa just posterior and superior to the tail of the middle turbinate on the lateral
nasal wall. At this aspect, there is no bony boundary to the SPG. Blocking the SPG using
local anesthetics relieves pain. Unfortunately, many current interventions are cumbersome,
invasive, and expensive. The purpose of this study is to evaluate the efficacy of the Tx360™,
a new nasal applicator device, in the treatment of head and face pain and to examine the
economic implications. The Tx360™ is a single use device designed to deliver a topical local
anesthetic to the specific area of mucosa associated with the SPG. A total of 42 study
participants will be accepted into this double-blind placebo-controlled study. 28 will
receive SPG blocks using a 0.3 mL of a 0.5% solution of Marcaine delivered by the Tx360™
while 14 will receive a placebo of saline substituted for the Marcaine. Both patient sets
will also be given a piece of lemon hard candy as a taste distractor. Participants must have
a chronic migraine history with over 15 symptomatic days per month over the past three
months. The treatment plan consists of six weeks of treatment, two times per week. Short and
longer term assessments will be retrieved and analyzed as detailed in the Study Design.