Combating the Opioid Epidemic

Clinical trials available to research alternatives to deadly painkillers.

Long before COVID-19 became the world’s greatest health concern, a crisis that health experts have blamed for nearly a million deaths this century was already raging:

The opioid epidemic.

In 2019, when the US reported an all-time high of nearly 72,000 deaths due to drug overdoses, more than two-thirds of those deaths involved opioids, a class of drug that includes legally prescribed pain relievers such as oxycodone and hydrocodone.

The advent of the coronavirus pandemic in 2020 exacerbated the problem. With access to counseling and support limited, the National Institute on Drug Abuse reports that opioid overdoses are claiming more than 90 American lives each day.

With millions suffering from opioid-use disorders each year, the Centers for Disease Control and Prevention is urging Medicare, Medicaid and private insurers to do more to prevent the opioid epidemic from spreading. Private practices can do more, too.

One that has taken up that gauntlet is Jax Spine & Pain Centers, which specializes in progressive interventional treatment options to address chronic joint, neck and back pain.

As part of its quest to help combat the use and overuse of opioids, Jax Spine & Pain Centers is conducting clinical research trials aimed at determining the efficacy of three advanced treatments for back pain experienced before and after surgery.

The goal is to find new and better treatments for diseases and other health conditions.

A ‘Gold Standard’

It’s rare for a private practice to delve deeply into clinical research, but Jax Spine & Pain Centers is not your typical private practice.

In addition to its medical staff, which includes seven physicians specializing in pain management, Jax Spine & Pain Centers employs its own clinical research director, Amanda Doris, to oversee its extensive involvement in clinical trials.

Amanda Headshot

Amanda joined Jax Spine & Pain enters largely because of its dedication to clinical research.

“Some practices are only concerned with the bottom line,” says Nicholas Bremer, MD. “That’s not the case here at Jax Spine & Pain Centers. In fact, that’s one of the reasons I joined the group. The focus of the senior partners is not to go through as many patients as we possibly can each day. Our focus is on doing the right thing for everybody, on maintaining a gold standard of care. Conducting
clinical research is part of that.

“Though we are not in an academic setting, we believe strongly in clinical research, in conducting clinical research in-house and being a part of those efforts to find the best solutions possible for patients everywhere.”

Like Dr. Bremer, Amanda joined Jax Spine & Pain Centers largely because of its dedication to clinical research. It’s a field she has been involved in her entire career, and she assures that Jax Spine & Pain Centers will be involved in more trials down the road.

For now, though, the practice is focused on finding better solutions for chronic back pain. They are looking for patients to participate in trials involving treatment devices that have been in use for several years.

The Stimulator Study

One of those devices is a spinal cord stimulator. Powered by a small battery that is implanted under the skin near the patient’s hip, a spinal cord stimulator is a small device that alters pain signals running to the brain.

The technology is not new. It was developed more than 30 years ago. Back then, the devices were created in a way that allowed pain signals to be replaced with a tingling sensation
called a paresthesia.

The latest models work the same way, but advanced technology allows for pain to be replaced with no sensation at all. The Jax Spine & Pain Centers study centers around one of the new stimulation waveforms.

“A lot of different types of stimulation have been developed just in the past five years, such as high-frequency stimulation and burst stimulation, where the stimulation is delivered in groups of pulses,” explains Michael Hanes, MD, of Jax Spine & Pain Centers.

Dr. hanes in a surgical room

“We’re doing this not just for our own patients, but for all patients everywhere who are suffering from pain.” – Dr. Hanes

“This trial is looking at the efficacy of one of those new waveforms, something called differential target multiplexed stimulation. It specifically targets the glial cells in the spinal cord, which we know are involved in the pain pathways. The thought is, if you can target those glial cells, you can modulate the way pain signals get sent to the brain. What we’re trying to determine is whether this technology is as good as the other waveforms.”

The spinal cord stimulator trial is a two-year study. It’s open to patients who have access to a smartphone and/or computer, are 18 or older, and have either been fit with a spinal cord stimulator previously or are receiving one for the first time.

“For patients who already have a spinal cord stimulator, anyone getting reported relief of 80 percent or greater is not eligible for the trial,” Amanda notes. “The trial is also not open to women who are pregnant or nursing.”

During the two-year study, data will be collected every month through a questionnaire that can be filled out online by the patient. Patients will also be asked to visit Jax Pain & Spine Centers three, six, 12, and 24 months post-implant for a personal evaluation.

“It’ll be just like a regular visit with the doctor, but I’ll come in with representatives of the company that makes the device and ask some additional questions to make sure their programming is beneficial and to their liking,” Amanda notes.

New patients who agree to participate in, and are ultimately selected for the spinal cord stimulation trial, will begin the trial by going through a three- to seven-day testing period to determine if the stimulator will have the desired effect.

If the patient experiences a significant reduction in pain during the testing period, the stimulator will be implanted permanently.

That process is done in a doctor’s office, where leads or electrodes are threaded through an epidural needle. The top of the electrode is fed into the epidural space of the spine, inside of the spinal canal but outside of the spinal cord. The bottom of the electrode is attached to a battery that sits on top of the skin during the trial.

In its quest to provide patients everywhere with the best possible solutions for their pain, the staff at Jax Spine & Pain Centers has made a commitment to conducting clinical research in-house.

The battery, which is about the size of a half-dollar, creates the impulses that block the pain signals. About 90 percent of patients going through the testing period receive enough relief to have the stimulator implanted permanently.

That permanent implant procedure is similar to the one performed for the trial, except that it is done at a hospital or surgery center.

The Spacer Study

The other two studies are designed to determine the efficacy of a small titanium spacing device that is frequently used in the treatment of mild to moderate lumbar stenosis, which is a narrowing of the spaces in the spine.

This narrowing leads to pain.

The spacing device is called the Superion®, and it’s implanted between the narrowing or compressed vertebrae. Once the Superion has been inserted, two “arms” are opened to lock it in place between the spinous processes.

One of the two Superion spacer studies is a five-year review for patients 45 and older that is called SCOPE. The other is a three-year program for patients 21 and older called PRESS2.

“The second study broadens our patient population a bit,” Amanda adds. “In both studies, the purpose is to compile real-world outcomes of the Superion in routine clinical practice. As it is with the spinal cord stimulator, we’re using a device that is already available to the population. It’s already market-approved, so our goal is to further advance the research and produce as much information as we can regarding its efficacy.”

Patients in the Superion spacer studies will be fit with the device during an hourlong implantation procedure that is typically done under twilight sedation in an outpatient surgery center so that no hospital stay is required.Superion® InterSpinous Spacer (Vertiflex)

The procedure begins with the physician making a small incision, about an inch long, in the lower back. The physician then inserts a small dilator or tube through which the spacer is deployed. Once deployed, the spacer is locked into place.

After receiving the spacer, patients will be evaluated in person at Jax Spine & Pain Centers every six months for the first year and once a year for the final four years for those in the five-year study.

“During those visits, the investigators will also perform a neurological exam just to make sure the patient is able to perform regular movements with the device,” Amanda notes. “And if for any reason the patient feels the device isn’t working, it can be removed.

“I also want to note that patients in both trials will be compensated for the screening visit and each follow up visit. In addition, the study sponsor will cover the entire cost of the device. Everything else will be going through insurance. There is also some exclusionary criteria for both studies.”

For the SCOPE study, the exclusionary criteria includes prior lumbar surgery, fusion or decompression treatment or a body mass index greater than 40. Also, anyone who has a history of substance abuse or substance-use disorder in the past five years would not be eligible.

“Others who are not eligible are people who have heart disease, fibromyalgia, osteoporosis, lumbar scoliosis and peripheral neuropathy, and anyone who is on workers’ compensation,”
Amanda details.

The main exclusion for the PRESS2 study is any prior decompression or lumbar surgery, which means anyone who has had kyphoplasty, some kind of minimally invasive decompression therapy or anything at the fusion level. In addition, anyone who has severe osteoporosis or lumbar scoliosis is not eligible.

Most of the patients selected for the trials will be referred by their doctors, but others can get information regarding eligibility by calling Jax Spine & Pain Centers or emailing Amanda at
amandad@jaxspine.com.

More To Come

Jax Spine & Pain Centers is also planning another trial for back pain therapy. Unlike the other three trials, this study will gauge the effectiveness of a new treatment.

Dr. Bremer headshot

Our focus is on doing the right thing for everybody, on maintaining a gold standard of care. Conducting clinical research is part of that. – Dr. Bremer

“There’s a new therapy called minimally invasive spinal fusion,” Dr. Hanes explains. “The device that’s used in this treatment is called the ZIP Ultra™. It’s made by a company called Aurora and it changes the way we do spinal fusion surgery.

“Previously, a spinal fusion was a huge surgery where the physician goes into the back and places rods and screws. With this new device, the physician goes in through a small incision and just slides the device between two of the bones in the spine, and it clamps on.”

Dr. Hanes says surgery using the ZIP Ultra is designed to provide patients with the same benefits as the more invasive, traditional spinal fusion surgery, with less trauma to the body.

Details regarding eligibility and exclusions for the ZIP Ultra trial are still being formulated, so it’s not yet certain when the practice will begin the trial. Dr. Hanes says he’s looking forward to obtaining results for its efficacy.

“As physicians, one thing we always want to do is stay current with the newest and best technologies and therapies available,” he concludes. “That’s a passion of mine and Dr. Bremer’s and everyone here at Jax Spine & Pain Centers.

“We look forward to doing the research in our field that results in better patient care and better patient outcomes. And we’re doing this not just for our own patients, but for all patients everywhere who are suffering from pain.”

© FHCN article by Roy Cummings. Spacer and simulator graphics and patient photo courtesy of Jax Spine & Pain Centers. mkb
Print This Article
    • Jax Spine & Pain Centers

      Jax Spine & Pain Centers is one of north Florida’s leading providers in progressive interventional pain relief for the treatment of back, neck, shoulder, knee, hip and chronic pain. Their team of board-certified physicians and ... Read More

    • Michael Hanes, MD

      Michael Hanes, MD, is a board-certified anesthesiologist and interventional pain medicine specialist. He earned his bachelor’s degree from the University of Michigan in 2006 and his medical degree from Michigan State University in 2010. He comp... Read More

    • Nicholas Bremer, MD

      Nicholas Bremer, MD, is a board-certified anesthesiologist and interventional pain medicine specialist. He earned his bachelor’s degree from Rutgers University in New Jersey in 2002 and his Doctor of Medicine degree from the University of Vermo... Read More