Americans spend at least $50 billion a year on lower back pain alone.

Lumbar spinal stenosis, a common cause of lower back and leg pain, is the most common reason for surgery in people age 60 and over.

Now, doctors are studying an effective and relatively easy way to relieve people of the pain.

As a full-time nurse with five children, Cheryl Dote spends a lot of time on her feet. For the last four years, she has done that with debilitating back and leg pain.

Dote said, "I would be in tears some nights."

She tried physical therapy, pain relievers and pain injections, but the pain always won.

Dote said, "I actually thought I was going to end up in a wheelchair."

Like more than a million other Americans, she has lumbar spinal stenosis. In her search for help, she found Orthopedic Spine Surgeon at Upstate Medical University Dr. Richard Tallarico.

Dr. Tallarico said, "In the most aggressive forms, patients can't stand to walk for even a few minutes, so it's very functionally disabling."

Standing or walking compresses the spine and pinches the nerves, causing pain. Patients only get relief when they are sitting or stooped over. Now, Dr. Tallarico and a team of doctors are studying the superion spacer to relieve the pain.

Dr. Tallarico said, "Compared to what we've had in the past, this is a much easier way to approach this from both the surgeon and the patient perspective."

First, surgeons make a half-inch incision in the back. The spacer is inserted where it is needed and acts like a wedge, which permanently spreads open the spinal canal.

Dr. Tallarico said, "It allows the spine to remain in a flexed position, mimicking the sitting position."

Dote had the spacer put in and says the relief she feels changed her life.

Dote said, "It was 100-percent better. It's still 100-percent better."

Now, her focus is on her kids, instead of her pain. The spacer is still under study, and the trial is open to patients across the country.

If study results hold up, doctors hope this will get FDA approval and be available to the masses within three years.

RESEARCH SUMMARY

BACKGROUND: The Superion Interspinous Spacer (ISS) in an investigational medical tool designed to relieve chronic pain that's caused by moderate lumbar spinal stenosis. Lumbar spinal stenosis is a condition that occurs when nerves in the lower back are compressed. This compression can put pressure on the spinal cord and nerve roots and cause leg, back and groin pain. ISS is a minimally-invasive alternative to traditional spinal surgery. The Superion ISS alternative doesn't require a large incision, and can therefore minimize the amount of bleeding and trauma to the body. (SOURCE: superionstudy.com)

TREATMENT OPTIONS: According to the Los Angeles Spine Institute, lumbar spinal stenosis is the cause of leg and back pain for nearly 1.2 million Americans. However, there are several treatment options available to relieve symptoms and improve a patient's activity level. Nonsurgical treatments are typically the first line of treatment options for patients who suffer mild to moderate symptoms. This often includes physical therapy, nerve block injections, and/or medicine. When nonsurgical treatments fail to provide relief, patients are traditionally offered a spinal decompression or fusion surgery. These procedures can require a large incision to remove bone and ligaments and can result in a lengthy recovery period.

SUPERION ISS TREATMENT & RECOVERY: The Superion ISS is implanted between the spinous processes through a half-inch skin incision. Once in place, the device can act as a support column to open the passageways that contain the spinal cord and nerve roots. This reduces the compression on the nerves and can therefore relieve pain. The recovery process is typically a short one. Patients may be able to return home the same day of the surgery or may be discharged from the hospital the following day. Physical therapy is usually recommended following the surgery. The type of rehabilitation program will vary from patient to patient. Since every patient's recovery process is different, the surgeon will have to determine how much post-surgical activity is appropriate on an individual basis. (SOURCE: superionstudy.com)

CLINICAL TRIAL: A clinical study is currently working to determine the safety and effectiveness of Superion ISS in treating lumbar spinal stenosis. This clinical study must be completed before Superion ISS can gain FDA approval for commercial use in the United States. The Superion device will be compared to the X-STOP IPD (an FDA-approved treatment, which is already commercially available in the United States). To qualify for this study, patients must already be diagnosed with moderate lumbar spinal stenosis and be at least 45 years old. Patient symptoms must include constant leg, back and/or groin pain that is relieved by sitting or bending forward. Study candidates will have experienced these symptoms for at least six months and cannot have already had a prior surgical procedure on the lumbar spine. Patients who meet the study criteria and agree to participate in the study are randomly chosen to receive either the X-STOP or the Superion ISS and will be evaluated at specific follow-up visits for 24 months after their surgery. (SOURCE: spineuniverse.com)

FOR MORE INFORMATION, PLEASE CONTACT:
Superion Study Patient Education
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