Hospital seeks participants for PTSD treatment study

By DREW BROOKS | The Fayetteville Observer (Tribune News Service) | Published: February 26, 2017

An ongoing medical study at Womack Army Medical Center that could impact future treatment for post-traumatic stress needs more participants, officials said.

The clinical trial, underway at Womack and at two other military hospitals, is looking at the use of a medical procedure known as a stellate-ganglion block.

The procedure involves a local anesthetic injected into a bundle of nerves in a patient's neck.
Patients have said the treatment can reduce anxiety, halt nightmares and stop the hyper-vigilance associated with post-traumatic stress. But the procedure is still largely unproven in scientific circles.

At Fort Bragg, Tripler Army Medical Center in Hawaii and Landstuhl Regional Medical Center in Germany, officials are hoping to gather data on more than 200 patients to provide the first scientific proof of the procedure's efficacy as a treatment for post-traumatic stress.

Womack, as a large military hospital at the nation's largest military installation, is expected to provide roughly half the participants in the clinical trial.

But since the trial began in June, officials said progress has been slower than hoped.

Dr. Michael Bartoszek, who has performed stellate-ganglion blocks hundreds of times for Fort Bragg troops suffering from post-traumatic stress, said the concern is that if the study takes too long, funding may be pulled.

"If we stall here then we're stuck and this procedure is stuck," he said.

Bartoszek said the trial's robust participant requirements and concerns that participants may be among the third who receive placebos are among the reasons for the slower-than-expected participation.

He said those who receive placebos can receive the real treatment as soon as they finish the three-month trial.

But that's enough time to dissuade some from participating, with them opting instead to receive the treatment outside of the clinical trial.

Bartoszek said the hospital, and other medical researchers, have plenty of data on the procedure's efficacy.

But the stricter clinical trials are needed to convince the government, other doctors and insurance companies to buy in and increase the availability of the treatment.

"We are confident doing this procedure," Bartoszek said. "We've done this and it seems to help."

But, he added, there's little motivation for outside groups, especially drug companies, to conduct a similar trial.

That's because the procedure has been around for decades, used to treat other medical issues. And the drugs used by doctors have long since gone generic.

"There's no economic motivation," Bartoszek said.

But if the trial is a success and proves the treatment is useful, Bartoszek said that could lead to increased access, helping "an innumerable amount of people," both military and civilian, who suffer from post-traumatic stress.

"The biggest thing is they're doing this for others," the doctor said. "The implications are bigger than them."

Participants in the study must be serving in the active-duty military, must not be deploying for at least three months and can't be facing a medical evaluation board.

They also must meet strict criteria for diagnosis of post-traumatic stress and not be suffering from behavioral health conditions that could impair their ability to participate in the clinical trials.

Bartoszek said they don't have to be based at Fort Bragg.

Any service member able to travel to Fort Bragg who meets the other requirements can participate, he said. That includes Marines from Camp Lejeune and airmen from Seymour Johnson Air Force Base.

Bartoszek said he's fielded calls from possible participants as far as Oklahoma and Philadelphia.
To help those participants, he said the Fisher House, located next to Womack, is providing a place to stay while waiting on the procedure.

The procedure takes less than five minutes to administer, Bartoszek said. But trial participants must receive two treatments, two weeks apart and then be available for two months of monitoring, which includes assessments and focus groups for the patient and family members.


(c) 2017 The Fayetteville Observer. Distributed by Tribune Content Agency, LLC.

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