Tx360® Studies & Resources

Pain Physician 2013;16;E769-E778.

A Novel Revision to the Classical Transnasal Topical Sphenopalatine Ganglion Block for the Treatment of Headache and Facial Pain

A Novel Revision to the Classical Transnasal Tropical Sphenopalatine Ganglion Block Treatment of Headache and Facial Pain has been printed by the Pain Physicians Journal: Offical Journal of the American Society of Interventional Pain Physicians.

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ABSTRACT

Pain Physician 2013;16;E769-E778.

A Novel Revision to the Classical Transnasal Topical Sphenopalatine Ganglion Block for the Treatment of Headache and Facial Pain Case Series. Kenneth D. Candido, MD, Scott T Massey, MD, Ruben Sauer, MD, Raheleh Rahimi Darabad, MD, and Nebojsa Nick Knezevic, MD, PhD.

BACKGROUND: The sphenopalatine ganglion (SPG) is located with some degree of variability near the tail or posterior aspect of the middle nasal turbinate. The SPG has been implicated as a strategic target in the treatment of various headache and facial pain conditions, some of which are featured in this manuscript. Interventions for blocking the SPG range from minimally to highly invasive procedures often associated with great cost and unfavorable risk profiles.

OBJECTIVE: The purpose of this pilot study was to present a novel, FDA-cleared medication delivery device, the Tx360® nasal applicator, incorporating a transnasal needleless topical approach for SPG blocks. This study features the technical aspects of this new device and presents some limited clinical experience observed in a small series of head and face pain cases.

STUDY DESIGN: Case series.

SETTINGS: Pain management center, part of teaching-community hospital, major metropolitan city, United States.

METHODS: After Institutional Review Board (IRB) approval, the technical aspects of this technique were examined on 3 patients presenting with various head and face pain conditions including trigeminal neuralgia (TN), chronic migraine headache (CM), and post-herpetic neuralgia (PHN).

The subsequent response to treatment and quality of life was quantified using the following tools: the 11-point Numeric Rating Scale (NRS), Modified Brief Pain Inventory — short form (MBPI-sf), Patient Global Impression of Change (PGIC), and patient satisfaction surveys. The Tx360® nasal applicator was used to deliver 0.5 mL of ropivacaine 0.5% and 2 mg of dexamethasone for SPG block. Post-procedural assessments were repeated at 15 and 30 minutes, and on days one, 7, 14, and 21 with a final assessment at 28 days post-treatment. All patients were followed for one year. Individual patients received up to 10 SPG blocks, as clinically indicated, after the initial 28 days.

RESULTS: Three women, ages 43, 18, and 15, presented with a variety of headache and face pain disorders including TN, CM, and PHN. All patients reported significant pain relief within the first 15 minutes post-treatment. A high degree of pain relief was sustained throughout the 28 day follow-up period for 2 of the 3 study participants. All 3 patients reported a high degree of satisfaction with this procedure. One patient developed minimal bleeding from the nose immediately post-treatment which resolved spontaneously in less than 5 minutes. Longer term follow-up (up to one year) demonstrated that additional SPG blocks over time provided a higher degree and longer lasting pain relief.

LIMITATIONS: Controlled double blind studies with a higher number of patients are needed to prove efficacy of this minimally invasive technique for SPG block.

CONCLUSION: SPG block with the Tx360® is a rapid, safe, easy, and reliable technique to accurately deliver topical transnasal analgesics to the area of mucosa associated with the SPG. This intervention can be delivered in as little as 10 seconds with the novice provider developing proficiency very quickly. Further investigation is certainly warranted related to technique efficacy, especially studies comparing efficacy of Tx360 and standard cotton swab techniques.

A Double-Blind, Placebo-Controlled Study of Transnasal Sphenopalatine Ganglion Blockade with Tx360® in the Treatment of Chronic Migraine: Evaluation of Patient Functional Outcomes

Roger Cady, MD 1 • Joel Saper, Md2 • Ryan Cady, MS1 • Heather Manley, MS1 • Jeanne Tarrasch, RN/BSN1 • Alice Oh, LPN1
1-Headache Care Center, Springfield, MO; 2-Michigan Head Pain & Neurological Institute, Ann Arbor, MI

BACKGROUND: The Sphenopalatine Ganglion (SPG) is a small concentrated structure of neuronal tissue that resides within the pterygopalatine fossa (PPF) in close proximity to the sphenopalatine foramen. The SPG is innervated by the maxillary division of the trigeminal nerve and has a sensory, parasympathetic, and sympathetic component. It has been implicated in several orofacial pain conditions including migraine. 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. Blocking the SPG using local anesthetics may relieve pain associated with chronic migraine.

The purpose of this study is to evaluate the safety and efficacy of 0.5% bupivacaine sphenopalatine ganglion blockades for the treatment of chronic migraine delivered via the Tx360® device. This device contains a small, flexible, soft plastic tube that is advanced below the middle turbinate just past the pterygopalatine fossa. The plastic tube can then be rotated laterally on a preset track and extended into the intranasal space. A total of 0.3 cc of anesthetic (0.5% bupivacaine) is injected through the tube and directed to the mucosa covering the SPG. The procedure is performed similarly in each nostril.

OBJECTIVES: This pilot study aimed to evaluate the Tx360® device through the review of patient reported outcomes in a chronic migraine population.

Primary Objective
To compare the impact of pain questions before treatment and 24 hours post treatment using the Tx360® device with 0.5% bupivacaine vs. saline.

Secondary Objectives
Compare the change in Headache Impact Test (HIT-6) scores from baseline to end of treatment for bupivacaine vs. saline.
Patient satisfaction with treatment for bupivacaine vs. saline.

Demographic Characteristics
Fifty-five subjects were screened for this study, meeting the proposed sample size of 42 subjects. The study population consisted of 41 subjects randomized per protocol. Subjects included 10 males and 31 females between the ages of 18-67 and a mean age of 41.30 with a diagnosis of ICHD-II definition of chronic migraine. The average length of chronic migraine diagnosis was 8.58 years. Subjects, on average, experienced 15.24 migraines and 23.63 headaches in a month during baseline. Of the randomized population, 34 were Caucasian, 4 were African American, and 3 Other. Forty subjects completed treatment, although 3 subjects had protocol violations and were therefore removed from the study. A total of 38 subjects were analyzed; 26 subjects treated with bupivacaine and 12 with saline.

METHODS: This was a 2 center, randomized, double-blind, placebo controlled study consisting of 55 screened subjects, 18 to 67 years of age, meeting the definition of chronic migraine. Subjects were asked to complete a daily baseline headache diary for 28 days. Following the baseline period, subjects meeting the diagnostic criteria for chronic migraine per diary analysis were randomized 2:1 receiving either 0.3 cc of 0.5% bupivacaine or saline delivered to the mucosal surface of the SPG though each nares with the Tx360® device. The procedure was repeated twice weekly for 6 weeks. Subjects continued to complete a daily headache diary throughout the treatment period and 1 month post treatment. Also during the treatment period, subjects completed a battery of questionnaires 15 and 30 minutes post treatment, as well as 24 hours post treatment.

RESULTS:

Subjects Treating with Bupivacaine Experienced Significant Reductions in Pain Levels 24 Hours Post Treatment

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Subjects in the bupivacaine group reported significantly lower levels of pain 24 hours after treatment (measured by greatest level of pain, least level of pain, average pain and percent relief). There was no significant change reported by subjects receiving saline as a sham treatment.

Mood, Work, Relationship, and Sleep Interference Ratings Significantly Decreased for Subjects Treating With Bupivacaine

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The bupivacaine group also reported a significantly improved ability to accomplish normal work related tasks (p = .004) and improved sleep (p < .001). The saline group showed increased impairment in their mood (p =.03) and relationships with others (p =.01). When looking at between group differences, all quality of life measurements, including general activity, mood, walking ability, work, relationships, sleep, and enjoyment of life, were significantly different between the bupivacaine and saline groups (p < .001).

HIT-6 Scores Significantly Decreased Following 6 Weeks of Treatment in Subjects Treating with Bupivacaine

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HIT-6 scores significantly decreased in the bupivacaine group (-4.75, p = .005) from baseline to the end of the treatment period (6 weeks) while again there was no significant change for the saline group (-1.55 p = .09). Average treatment satisfaction scores at the end of the treatment period (6 weeks) were significantly higher for Group A compared with Group B. (3.50 vs. 2.91, p < .001).

Satisfaction Scores Were Significantly Higher for the Bupivacaine Group Compared to the Saline Group

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CONCLUSION: Repetitive SPG blocks utilizing 0.5% bupivacaine delivered by through a Tx360® device significantly reduced pain associated with chronic migraine. Furthermore, subjects reported better sleep and increased function at work over the 6 week time of the study. Additionally, subjects receiving the active treatment had significant improvement in HIT-6 scores at the end of the treatment period vs. baseline. These results suggest that repetitive SPG blockade with 0.5% bupivacaine administered with the Tx360® device may be an efficacious treatment and improve clinical outcomes for patients with chronic migraine.

To download study abstract click here

Download AHS 2014 Tx360 Clinical Outcomes Poster

S22 2014 SAEM Abstract

Sphenopalatine Ganglion Anesthesia for Acute Headache in the Emergency Department Using a Novel Delivery Device

Jason T Schaffer, Kevin Ball, Benton Hunter, and Christopher Weaver
Indiana University, Indianapolis, IN

BACKGROUND: Acute headache is a common chief complaint in patients presenting to the ED. Sphenopalatine ganglion (SPG) anesthesia has been described for the treatment of cluster headache but no prospective studies exist for its use in undifferentiated acute headache.

OBJECTIVES: To assess the effectiveness of SPG anesthesia in treating acute anterior headache in the ED using a noninvasive approach with the Tx360 device. We hypothesized a 30% improvement in number of patients achieving 50% reduction in pain by VAS at 15 minutes with bupivacaine as compared to placebo.

METHODS: Randomized double-blinded placebo-controlled trial of bupivacaine anesthesia of the SPG using the Tx360 device (Figure 42). ED patients with anterior focused or global acute headache were identified. Study sample size was calculated (n=84) for 80% power to detect a difference between groups for the primary endpoint of 50% reduction in pain by VAS. Bupivacaine or normal saline (NS) were delivered (0.3ml per each nare) using the Tx360 device. The Tx360 is a catheter device that directionally sprays the medication intranasally onto the mucosal surface over the SPG. Pain and nausea were measured at time=0, 5, and 15 minutes by a 100mm VAS. Phonecall follow-up assessed secondary endpoints of 24-hour pain and nausea.

RESULTS: The mean reported baseline VAS for pain in the bupivacaine group was 77.2 ±18.2 and 76.7 ±18.1 in the NS group. At 15 minutes the mean reported VAS for pain in the bupivacaine group was 39 ±34.5 and 47.6 ±35.1 in the NS group (p=0.289). A 50% reduction in pain was achieved in 50% (20/40 patients) of the bupivacaine group vs. 40.4% (19/ 47 patients) in the NS group (p=0.311). There were no adverse side effects reported in either group. At 24 hours there was a significant difference in report of headache (29% vs. 54%, p=0.037) and nausea (3.4% vs. 28%, p=0.009) favoring the bupivacaine group.

CONCLUSION: For treatment of acute headache with SPG anesthesia vs placebo, there was no difference at 15 minutes for SPG anesthesia. At 24 hours, we found a statistically significant benefit for the anesthesia group versus the placebo group.

To download study abstract click here

A Double-Blind, Placebo-Controlled Study of Transnasal Sphenopalatine Ganglion Blockade with TX360 in the Treatment of Chronic Migraine: Evaluation of Patient Reported Outcomes

OBJECTIVES: Compare Modified Brief Pain Inventory Scores before treatment and 24 hours post treatment for TX360 with 0.5% bupivacaine (Group A) vs. saline (Group B)
Compare baseline and post treatment HIT-6 scores for Group A vs. Group B
Compare patient satisfaction with treatment for Group A vs. Group B

BACKGROUND: The sphenopalatine ganglion (SPG) is a small heart shaped structure that resides within the pterygopalatine fossa in close proximity to the sphenopalatine foramen. It has been implicated in several orofacial pain conditions including migraine. It is largely innervated by the maxillary nerve. 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. Blocking the SPG using local anesthetics may relieve pain associated with chronic migraine. Unfortunately, many current interventions are cumbersome, invasive, and expensive. Some are associated with significant and sometimes serious adverse events. The purpose of this study is to evaluate the efficacy and usability of the Tx360, a new nasal applicator device, utilizing 0.5% bupivacaine vs. saline in the treatment of chronic migraine.

METHODS: This was a 2 center, randomized, double-blind, placebo controlled study consisting of 55 screened subjects, 18 to 65 years of age, meeting the ICHD-11 appendix definition of chronic migraine. Subjects were asked to complete a daily baseline headache diary for 28 days. Following the baseline period, 41 subjects met diagnostic criteria for per diary analysis and were randomized 2:1 receiving either 0.3 ml of O.5% bupivacaine or saline delivered to the mucosal surface of the SPG though each nares with the Tx360 device. The procedure was repeated twice weekly for 6 weeks.

RESULTS: Subjects in Group A reported significantly lower levels of pain 24 hours after treatment (measured by greatest level of pain, least level of pain, average pain and percent relief). There was no significant change reported by subjects receiving saline as a sham treatment. Group A also reported a significantly improved ability to accomplish normal work related tasks and improved sleep. There was no change in these activities for Group B. HIT -6 scores significantly decreased in Group A, the active treatment group (-4.75, p < 0.01) from baseline to after the last treatment (6 weeks) while again there was no significant change for group B (-1.55 p =0.09). Average treatment satisfaction scores at the end of the treatment period (6 weeks) were significantly higher for Group A compared with Group B. (3.50 vs. 2.91, p < 0.001).

CONCLUSIONS: Repetitive SPG blocks utilizing 0.5% bupivacaine delivered by through a TX360 device significantly reduced pain associated with chronic migraine. Further subjects reported better sleep and increased function at work over the 6 week time of the study. Additionally subjects receiving the active treatment had significant improvement in HIT-6 scores at the end of the treatment period vs. baseline. These results suggest that repetitive SPG blockade with 0.5% bupivacaine administered with the TX360 device may be an efficacious treatment and improve clinical outcomes for patients with chronic migraine.

To download study abstract click here

A Double-Blind, Placebo-Controlled Study of Transnasal Sphenopalatine Ganglion Blockade with TX360 in the Treatment of Chronic Migraine: Evaluation of Clinical Outcomes

OBJECTIVES: Compare Numeric Rating Scale (NRS) score between active and sham treatment groups.
Compare the number of headache days between active and sham treatment groups
Compare 24-hour after procedure Patient’s Global Impression of Change (PGIC) score for between active and sham treatments groups.
Compare acute medications usage between active and sham treatment groups.
Compare the adverse events of subjects receiving SPG block with bupivacaine vs. saline.

BACKGROUND: The sphenopalatine ganglion (SPG) is a small heart shaped structure that resides deep within the pterygopalatine fossa in close proximity to the sphenopalatine foramen and is implicated in orofacial pain conditions including migraine. It is largely innervated by the maxillary nerve. 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. Blocking the SPG using local anesthetics relieves pain. Unfortunately, many current interventions are cumbersome, invasive, expensive and some associated with significant adverse events. The purpose of this study is to evaluate the efficacy and usability of the Tx360, a new nasal applicator device, in the treatment of migraine.

METHODS:This was a 2 center, randomized, double-blind, placebo controlled study consisting of 55 screened subjects, 18 to 65 years of age, meeting the ICHD-11 appendix definition of chronic migraine. Subjects were asked to complete a daily baseline headache diary for 28 days. Following the baseline period, 41 subjects met diagnostic criteria for chronic migraine per diary analysis and were randomized 2: 1 receiving either 0.3 mL of 0.5% bupivacaine or saline delivered to the mucosal surface of the SPG though each nares with the Tx360® device. The procedure was repeated twice weekly for 6 weeks.

RESULTS:There was a reduction in the NRS in subjects receiving the active treatment compared to the sham procedure at 15 min (3.51 vs 2.53, p<0.0001), 30 min (3.45 vs 2.41, p < 0,0001), and 24 hours post treatment (4.20 vs 2.85, p < 0.001). Subjects in the treatment group had a reduction in the number of headache days per month from baseline to the end of treatment period while the sham group did not (-3.58 days vs. -0.75 days, p < 0.01). Furthermore subjects receiving active treatment had significant decreases in Patients Global Impression of Change compared to the sham treatment group at 30 min (3.72 vs. 3.00, p < 0.001) and 24 hours (3.88 vs 3.08, p < 0.001) post treatment. Total acute medication usage was similar between the two groups. However, the average usage of opioids per subject during the treatment phase was lower in the treatment group compared to the sham group (8.33 vs. 45.7). No serious adverse events were reported and there was no difference in non-serious adverse events between groups.

CONCLUSIONS: SPG blocks using the TX360 device provide rapid and sustained migraine relief for a population of patients with chronic migraine. Importantly, subjects in the treatment group experienced a significant reduction in headache days during the treatment. This study provides evidence for the effectiveness and tolerability of treating chronic migraine with the TX360 device.

To download study abstract click here

Resting State Functional Connectivity After Sphenopalatine Ganglion Blocks in Chronic Migraine With Medication Overuse Headache: A Pilot Longitudinal fMRI Study

Kaitlin Krebs, MSc; Chris Rorden, PhD; X. Michelle Androulakis, MD, MSc

Objective.—In this pilot study, the purpose is to investigate if a series of sphenopalatine ganglion (SPG) blockade treatments modulate the functional connectivity within the salience and central executive network (CEN) in chronic migraine with medication overuse headaches (CMw/MOH).
Background.—Using intranasal local anesthesia to block the SPG for the treatment of various headache disorders has been employed in clinical practice since the early 1900s. However, the exact mechanism of how SPG modulate resting state intrinsic functional brain networks connectivity remains to be elucidated. This pilot study seeks to understand the resting state connectivity changes in salience and CENs, with emphasis on the mesocorticolimbic systems, before and after a series
of SPG block treatments.

Methods.—Using fMRI, resting state connectivity was derived from predefined networks of nodes (regions of interests) for the salience (27 nodes, 351 connections) and CENs (17 nodes, 136 connections). After treatments, a paired samples t-test (with 10,000 permutations to correct for multiple comparison) was used to evaluate changes in the intranetwork
resting state functional connectivity within the salience and executive networks, as well as the overall network connectivity strength.

Results.—When comparing connectivity strength at baseline to that at the end of treatment in our cohort of 10 CMw/MOH participants, there were several connections within the salience (n 5 9) and executive (n 5 8) networks that were significantly improved. Within the salience network, improved connectivity was observed between the prefrontal cortex and various regions of the insula, basal ganglia, motor, and frontal cortex. Additionally, changes in connectivity were observed between regions of the temporal cortex with the basal ganglia and supramarginal gyrus. Within the CEN, improved connectivity was observed between the prefrontal cortex and regions of the anterior thalamus, caudate, and frontal cortex. After treatment, the overall CEN connectivity was significantly improved (Baseline 0.00 6 0.08; 6 weeks 0.03 6 0.09, P 5 .01); however, the overall salience network connectivity was not significantly improved (Baseline 20.01 6 0.10; 6 weeks
0.01 6 0.12, P 5 .26). Additionally, after treatment, there was a significant reduction in the number of moderate/severe headache days per month (Baseline 21.1 6 6.6; 6 weeks 11.2 6 6.5, P < .001), HIT-6 (Baseline 66.1 6 2.6; 6 weeks 60.2 6 3.6, P < .001), and PHQ-9 (Baseline 12.4 6 5.7; 6 weeks 6.1 6 3.6, P 5 .008) scores.

Conclusion.—In this longitudinal fMRI study, we observed improved functional connectivity within both networks, primarily involving connectivity between regions of the prefrontal cortex and limbic (cortical-limbic) structures, and between different cortical (cortical-cortical) regions after a series of repetitive SPG blockades. The overall CEN strength was also improved. Our results suggest that recurrent parasympathetic inhibition via SPG is associated with improved functional connectivity in brain regions critical to pain processing in CMw/MOH.

Key words: salience network, central executive network, fMRI, chronic migraine, sphenopalatine ganglion, resting state
connectivity

Abbreviations: ASC 12 allodynia symptom checklist, aPFC anterior PFC, BOLD blood oxygenation level dependent,
CEN central executive network, CM chronic migraine, CMw/MOH chronic migraine with medication overuse
headaches, dACC dorsal anterior cingulate cortex, dCaudate dorsal caudate, dmPFC dorsal medial
PFC, dPFC/FEF dorsal PFC/frontal eye field, dlPFC dorsolateral prefrontal cortex, TE echo time, EA
extended amygdala, FOV field of view, HIT-6 headache impact test, IFG inferior frontal gyrus, MPRAGE
magnetization-prepared rapid gradient echo, MNI Montreal Neurological Institute, NTNC node to
node connectivity, NSAIDs nonsteroidal anti-inflammatory drugs, OFI orbitofrontal insula, PHQ-9 Patient
Health Questionnaire, PAG periaqueductal gray, PFC prefrontal cortex, ROIs region of interest, TR repetition
time, SN salience network, SPG sphenopalatine ganglion, SSN superior salivatory nucleus, SMA supplementary
motor area, SMG supramarginal gyrus, vSP ventral striatum/pallidum, VTA/SNPC ventral
tegmental area/Substantia nigra, vlPFC ventrolateral PFC, vmCaudate ventromedial caudate

(Headache 2018;58:732-743)

To download complete study click here

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