Nancy A. Melville

March 30, 2015

NATIONAL HARBOR, MD — Treatment of chronic migraine with an sphenopalatine ganglion (SPG) block using intranasal technology (Tx360, Tian Medical) effectively reduces the frequency and severity of pain associated with the headaches up to a month after treatment, a new trial shows.

"We expected the reduction in headaches during treatment, but it was a surprise to see the continued effect even a month after treatment," presenting author Ryan Cady, MS, from the Banyan Group Inc, Springfield, Missouri, told Medscape Medical News.

The results were presented here at the American Academy of Pain Medicine (AAPM) 31st Annual Meeting. The study was funded by Tian Medical.

Poor Accuracy

Blocking of the SPG, a small structure of neuronal tissue near the sphenopalatine implicated in orofacial pain, has long been used in the treatment of chronic migraine, but the duration of relief has often been limited because of poor accuracy in accessing the SPG.

Although the block is traditionally applied by using a cotton swab, the intranasal technology, which has approval from the US Food and Drug Administration, is unique. It uses a small, flexible plastic tube that can be extended in the intranasal space.

The study is the first double-blind, randomized, controlled trial of such a device to provide evidence of efficacy, the researchers said.

For the two-center pilot study, 38 patients with chronic migraine aged 18 to 67 were randomly assigned to treatment with the SPG block, using 0.33 mL of 0.5% bupivacaine (n = 26) or saline as a sham treatment (n = 12). In both groups the solutions were delivered to the mucosal surface of the SPG intranasally with the Tx360 device.

The treatment was repeated twice weekly for 6 weeks.

Compared with baseline (according to pretreatment headache diaries patients completed for comparison), patients in the bupivacaine group showed significantly greater reductions in the number of headache days at the end of the 6-week treatment period, as well as 1 month after treatment (both P = .001).

Patients in the saline group showed no improvements over baseline.

Those receiving bupivacaine also had reductions in average pain ratings (P = .001), improvements in general activity interference (P = .05) and mood (P = .02), and improved ability to accomplish normal work-related tasks (P = .004).

The placebo group had some small increases in mood (P = .38) and only slight reductions in average pain, general activity, and work interference.

Decreases in Headache Impact Test scores were also significantly greater in the bupivacaine group (–4.52; P = .005) compared with the saline group (–1.50; P = .13) at the end of the treatment period, as well as at 1 month after treatment (–5.13 [P = .005] for bupivacaine vs –2.08 [P = .19] for saline) and at 6 months after treatment (–4.78 [P = .003] vs –1.58 [P = .36] for saline).

Adverse events did not significantly differ between the two groups.

Previously reported findings from the same study also showed significant improvements in all of the measures at 24 hours after treatment compared with before treatment and compared with the sham group.

"This was a pilot study and we hope to have future studies looking at a broader patient population and some of the possible shortcomings," Cady said.

Useful Evidence

Asked for commend on these findings, Samer Narouze, MD, PhD, chairman of the Center for Pain Medicine at Western Reserve Hospital, Cuyahoga Falls, Ohio, said the study provides useful evidence on the benefits of the treatment.

"I think there will be a lot of interest in this because there is growing interest in general in interventional headache treatments," he told Medscape Medical News.

"The study is unique as it is the first randomized controlled trial concerning SPG block for the treatment of migraines."

The study builds on previous research showing similar benefit of SPG block in cluster headache, Dr Narouze added.

"From case series and experience we learned that SPG block helps with migraine and not only cluster headaches. Now this study confirmed these observations."

The study was supported by Tian Medical LLC. Ryan Cady is director of research for Clinvest, a division of Banyan Group Inc. Dr Narouze has disclosed no relevant financial relationships.

American Academy of Pain Medicine (AAPM) 31st Annual Meeting. Abstract 220. Presented March 20, 2015.

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