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Director of Landstuhl Regional Medical Center's Interdisciplinary Pain Management Center Dr. Jeffrey Tiedeprepares to administer a stellate ganglion block for Master Sgt. Randall Kimble at LRMC on Oct. 24, 2016. Thisprocedure involves injecting a local anesthetic into a patient's neck and often helps manage certain types of pain.A new study at LRMC is seeking patient volunteers to help determine if the stellate ganglion block can alsoaddress symptoms of Post Traumatic Stress Disorder.Stacy Sanning/U.S. Army

By JENNIFER H. SVAN (/reporters/2.1269?author=Jennifer_H. Svan) | STARS AND STRIPESPublished: November 6, 2016

KAISERSLAUTERN, Germany — A treatment involving the injection of a local anesthetic next to a bundleof nerves in the neck has eased post­traumatic stress symptoms in some patients in as little as 30minutes with dramatic, lasting results.

Now, the Pentagon is funding a study at three Army medical centers to determine if the technique — longused for the treatment of pain — is truly effective in treating PTSD.

The results from the largest random, controlled trial using the stellate ganglion block could revolutionizethe way PTSD — considered a mental illness — is viewed and treated, according to doctors familiar withthe experimental procedure.

“It really is the tipping point,” Col. James Lynch, command surgeon for U.S. Special OperationsCommand Africa in Stuttgart, who has seen firsthand the promising effects of the shot, said about thecurrent trial.

“It has the potential to be a huge game changer for many, many affected people with PTSD,” whetherfrom combat, sexual assault or other trauma, he said. “There’s really not been a great answer for thisgiant population.”

The U.S. government has spent millions treating PTSD and searching for effective therapies since thewars in Iraq and Afghanistan thrust the disorder into the national spotlight.

If proved to be effective, the block could provide relief to millions of servicemembers and veterans whosuffer from combat­related PTSD.

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The stellate ganglion block is offered as treatment for PTSD at a handful of Army hospitals, includingLandstuhl Regional Medical Center in Germany, but it has yet to gain wide acceptance as a therapy forthe disorder because of the lack of clinical evidence proving the intervention works.

The Pentagon study could change that.

RTI International, a research institute in Raleigh, N.C., received a $2 million grant from the U.S. DefenseDepartment to conduct the trial.

Besides Landstuhl, Womack Army Medical Center at Fort Bragg, N.C., and Tripler Army Medical Center inHonolulu, Hawaii, are participating.

PTSD can occur after experiencing or witnessing a life­threatening trauma and may cause hypervigilance,hyperarousal, flashbacks, fear, anxiety, avoidance, sadness or other symptoms, according to theAmerican Psychiatric Association.

The illness has been particularly vexing for the U.S. military. Diagnosis of the disorder is at an all­timehigh among servicemembers and veterans, yet the effectiveness of approved treatments, such as drugsand cognitive therapy, has been mixed.

Up to 20 percent of veterans who fought in Afghanistan or Iraq are diagnosed with PTSD in any givenyear, compared with 12 percent who served in the Gulf War and 15 percent in Vietnam, according to theU.S. Department of Veterans Affairs.

Though millions of dollars have been sunk into research for alternative therapies for PTSD, from virtualreality to cannabis, the stellate ganglion block holds particular promise and should be a high priority forresearch, according to scientists from Johns Hopkins University. “The rapid response anddestigmatization the procedure offers may enable this technique to be beneficial for particularly difficult­to­treat patient populations, including military servicemembers and veterans,” the researchers said in areport published in October in World Institute of Pain.

Recruiting volunteersAnecdotal evidence indicates that “for a significant portion of patients, relief is near immediate, and that’svery powerful,” said Kristine Rae Olmsted, a behavioral epidemiologist at RTI and co­investigator in thePentagon­funded study.

But the procedure isn’t proposed as a cure­all, even if it’s proved to be effective, she said. “We still wantpeople to engage with behavioral health providers, to deal with the other psychosocial impacts of PTSD.”

Enrollment for the study began about five months ago. Researchers are hoping to get at least 240 active­duty military volunteers by the time the study concludes in November 2017, she said.

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But so far, recruitment of volunteers has been difficult, Rae Olmsted said. The study is open to active­dutyservicemembers who have been diagnosed with PTSD or think they might have PTSD. In an effort toincrease enrollment, the study was recently opened to servicemembers being treated for psychological orbehavioral health issues, LRMC officials said. Volunteers can receive up to $115 for the time they spendparticipating in the study.

“The stigma associated with PTSD certainly is a consideration,” Rae Olmsted said of the challenges inrecruiting volunteers for the study. Also, “people are a little leery about getting an injection in the neck. Forsome people, it’s not that big of a deal; for others, it’s quite off­putting.”

Dr. Jeffrey Tiede, director of the Interdisciplinary Pain Management Center at Landstuhl RegionalMedical Center, injects a local anesthetic into Master Sgt. Randall Kimble's neck during a stellateganglion block procedure at LRMC on Oct. 24, 2016. A new study at LRMC is seeking patientvolunteers to help determine if the stellate ganglion block can address symptoms of Post TraumaticStress Disorder.STACY SANNING/U.S. ARMY

Individuals will be screened for PTSD symptoms in advance. The source of PTSD can be any traumaticexperience, not just combat, Rae Olmsted said.

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Volunteers receive two injections, two weeks apart. One in three receive a placebo of saline solutioninstead of the active treatment, she said.

There are always risks involved with any injections, said Dr. Jeffrey Tiede, anesthesiologist and thedirector of LRMC’s Interdisciplinary Pain Management Center, such as bleeding or nerve damage, butwith this procedure, “it’s very low risk” and carries a potentially very high benefit.

Tiede has administered about 100 stellate ganglion blocks at LRMC this year, mainly for PTSD but forother pain indications, as well, he said. An ultrasound machine is used to help guide needle placement,Tiede said.

“Start to finish, is 10, 15 minutes tops,” he said.

“Even some of the soldiers that are absolutely scared of needles, that have a needle phobia ... when theyget done, (they say) ‘ah, that wasn’t a big deal at all,’” Tiede said.

From hot flashes to PTSDThe stellate ganglion is a cluster of nerves at the front of the neck. The block is a standard procedurethat’s been used for decades to treat chronic pain, Rae Olmsted said.

Chicago anesthesiologist Dr. Eugene Lipov pioneered the procedure for PTSD about 10 years ago, afterdiscovering the block gave relief to women suffering from menopausal hot flashes.

To defend the unorthodox treatment of hot flashes and to better understand why the block was effective,Lipov said he began to research “everything and anything that’s unique” about the stellate ganglion.That’s when he found a Finnish paper on the use of the stellate block to treat anxiety.

Lipov called his brother, Sergei, an internist, and told him: “If you have a patient suffering from PTSD,send him to me.”

Among Lipov’s first patients were Iraq and Afghanistan war veterans with severe PTSD. One was asoldier who had attempted to strangle his wife in his sleep. The shot took immediate effect, but a secondblock was needed after a fireworks display retriggered some of his symptoms. “He is doing great,” Lipovsaid.

He believes the block reduces nerve growth factor — a protein necessary for nerve cell survival and newnerve growth — to pre­trauma levels. NGF can surge in response to stress and fear, causing newsympathetic nerve endings to sprout in the brain, Lipov said.

The excess nerves produce more norepinephrine, which is similar to adrenaline, and can trigger chronicstress, heightening the “fight or flight” response, he said.

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With the injection, “the whole cascade reverses,” Lipov said, an event demonstrated during experimentson rats. “The sprouting falls off, norepinephrine falls to normal levels and people now are calm andcollected.”

Why this happens so quickly is a question that needs further study, he said. He believes it has somethingto do with the secretion of norepinephrine, which is regulated by the stellate ganglion.

“It takes about 15 minutes for norepinephrine to be removed by the system,” he said. “That is why theyfeel better right away, I believe.”

Lipov says if the block works, its effects are noticeable almost immediately.

Before administering the injection, he asks patients to think about what caused the trauma. “Womenusually cry and men get pissed off,” he said.

After 30 minutes or so, Lipov asks the same question.

“One of the soldiers had a great description,” he said. “He said before the block, he could feel, smell thegore. After the block, he said it feels like he was watching a black­and­white movie.”

Lipov’s initial success rate with the block was about 70 to 75 percent, he said. He’s since pushed thatabove 90 percent by doing a sequential block. After the first injection, Lipov waits about an hour. If they’veshown no improvement, he’ll do another injection, higher up in the neck.

“I’ve had almost no failures with this combination,” he said.

The ‘God block’Lipov had tried for years to get the Defense Department to support a clinical trial on the treatment.Multiple applications for federal funds to sponsor further study had been denied, he said.

The reason the Pentagon finally opened its purse strings was demand from the special operationscommunity, he said.

“The special ops people, they call it the ‘God block,’ because it changes their life and they’re moreeffective doing their work,” Lipov said.

Lynch, of SOCOM Africa, said he’s never heard it called that, but would agree that use of the block in thespecial operations community helped push the procedure along. That work began with Col. SeanMulvaney, currently a pain and sports medicine physician at Fort Belvoir Hospital in Virginia, Lynch said.

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As an army special operations doctor, Mulvaney “was getting guys with PTSD that were not comingforward openly and he didn’t have any good answers for them,” Lynch said. “Sean just started googlingcrazy options” and found Lipov.

Mulvaney set up some of his patients to get a stellate ganglion block at Walter Reed National MedicalMilitary Center by pain providers with experience using the procedure, though not for PTSD symptoms,Lynch said.

“They had dramatic results,” he said.

Lynch admits he was skeptical.

“I couldn’t rationalize the path of physiology in my head,” he said. “I just wrote it off as ‘Sean’s kind ofkooky’ and was onto something really kooky.”

Mulvaney and Lynch eventually became certified to administer the block to their patients in specialoperations units to which they were assigned in the U.S.

They collaborated on several studies and among their findings in the largest case series published: Of166 military members with multiple combat deployments who received the block, more than 70 percentreported significant improvements in PTSD symptoms three to six months out, according to one study.

Curiously, the block appears to reset the fight­or­flight response, rather than subdue it, doctors familiarwith the procedure say.

Lynch said he’s heard soldiers ask: “’Well, hang on a second, you’re telling me you’re going to block myfight­or­flight mechanism? I’ve been training 20 years in the Army to hone that sucker. I don’t wantsomething blocking,’” that, he said.

Lynch and his colleagues did a small study examining reaction time immediately after receiving the blockand a week after treatment to make sure there wasn’t a decline in a soldier’s ability to fight.

The outcome “was surprising,” he said. “Things got better. Reaction time got better.”

Though the block has been given to more than 1,000 patients at five U.S. military hospitals and has beenstudied for years, it’s still not widely accepted as a standard method of care for PTSD, Lynch said.

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“Many folks are slow to adopt a new treatment, particularly something that could be invasive, like a needlein the neck, unless there’s adequate literature to show that it’s effective,” he said.

More research neededNot all studies done on the treatment to date have shown it to be effective, however.

Results published in 2015 from a randomized, controlled trial involving 42 patients at Naval MedicalCenter San Diego found that stellate ganglion block performed no better than a placebo in relieving PTSDsymptoms.

Dr. Robert McLay, a psychiatrist and senior author of the study, said that while the study did not supportthe use of stellate ganglion block for PTSD, “it also did not eliminate it as a possibility.”

Of the 42 servicemembers with PTSD, 27 were chosen randomly to receive stellate ganglion block and 15were given a sham injection. Results showed PTSD symptoms improved significantly for both groupsafter treatment, but there was no clinically significant difference in outcomes between the active andcontrol groups, according to the study. Those who received a second block showed greaterimprovements, the research team reported.

The study showed definitively that the block “is not a panacea that works for everyone, that there can be aplacebo effect from the treatment, and that the procedure, although relatively safe, is not entirely withoutrisks,” McLay told Stars and Stripes in an email.

All medical procedures carry risks, McLay said. With the stellate block, people often will experience atemporary numbing in the arm and face, possibly difficulty swallowing, and there is a small risk of damageto nerves, blood vessels or the lungs, he said.

Lipov questioned the design of the study, pointing to the very small population size involved and that thestudy did not use an active placebo, one that mimics the side effects of the actual block.

McLay said more research is needed.

“It is definitely worth keeping an open mind,” McLay said. “An open mind doesn’t mean letting your brainfall out, however. We need good science, and that means multiple studies, to support or refute SGB.”

‘It’s like a miracle’For Brooke Byers, the procedure seemed more miracle than science when she considers the effect it hadon her husband, Clint Byers, a former Army intelligence officer, and their family.

About five years ago, Clint Byers returned from a combat deployment to Afghanistan a changed man, shesaid.

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Officially diagnosed with PTSD, he experienced a progressive deterioration in his quality of life. Therewas memory loss, irritability, insomnia.

“We couldn’t eat out, we could not go to a shopping mall, we could not be in large crowds,” she said. “Hewas on constant alert and in constant fear. He was constantly scanning crowds and looking for threats.”

Therapy and prescription Zoloft didn’t work, she said.

“He was in bad shape for a really long time,” she said. “It was to the point where I was questioning howmuch longer I could be in this marriage; how much longer are we going to put the kids through this kind oflife that we had at the time?”

Then, Clint Byers’ father saw Lipov on TV talking about the stellate ganglion block on “The Doctors.”

The Byerses scraped together $1,000 to cover the procedure — the VA wouldn’t pay for it — and airfarefor the couple to fly from their home in Tampa, Fla., to Chicago, where Lipov practices.

Clint Byers received the block in May 2015. The effects took hold almost immediately.

“He was giddy. He was just so happy and joyful for the first time in several years,” Brooke Byers said.

Those feelings persisted into the next day.

“He literally leapt out of the hotel bed and flung the curtains open, he was so elated,” she said.

On the plane trip home, Brooke Byers turned to her husband and said: “’I’m so happy that you’re sohappy, but I’m going to need you to dial it back a bit,’” she said, laughing at the memory. “I told himeverybody on the plane doesn’t need to hear how happy you are. I thought, ‘Oh, Lord, they’re going tothink he’s on something.’”

She said she was on high alert for several weeks after the procedure. “I was so paranoid it was going towear off all of a sudden, because we don’t know how long it will last,” she said.

“He’s still great,” she said. “I’ve got this man back whom I have not known in years. It’s like a miracle, nojoke.”

Lynch urges those who have or think they may have PTSD to at least consider participating in the currentstudy.

He’s heard soldiers express concern about not wanting to be a “guinea pig” by participating in an“experimental” study. The study, he emphasized, is not experimental; the procedure has been performedfor a number of years and numerous studies have been done, just none large enough to propel thetreatment into the mainstream.

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“It will take having enough participants in this study to truly determine whether SGB is effective,” RaeOlmsted said. “If it is, then the procedure can be adopted tri­service­wide, as well as in veteran andcivilian communities, to offer hope to those suffering from the often debilitating symptoms of PTSD.”

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Brown University students tore up, threw out American flags at Veterans Day ceremony(/news/us/brown­university­students­tore­up­threw­out­american­flags­at­veterans­day­ceremony­1.439385)

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