Why DenerveX^®?

INNOVATIVE | MINIMALLY INVASIVE | LONG-LASTING PAIN RELIEF

LOWER BACK PAIN CAUSED BY OSTEOARTHRITIS

Facet Joint Syndrome

The facet joints are located between the vertebrae in the spine and allow the back to be flexible while bending and rotating. They also allow nerves to exit the spinal cord, leading to other parts of the body. The cartilage in the facet joints are what allow the vertebrae to move smoothly against each other without grinding. Additionally, synovial fluid lubricates the facet joints to help protect against wear and tear. Facet Joint Syndrome, also known as osteoarthritis, occurs when those joints become swollen and painful.

Causes

Facet Joint Syndrome can be caused by any number of issues, including aging, pressure overload of the facet joints, and/or injury.
As the intervertebral discs degenerate, they wear down and begin to collapse, causing pressure overload. This narrows the space between each vertebra, which affects the way facet joints align and places extensive pressure on the cartilage of the facet joint. The pressure wears away necessary cartilage.
As facet joint arthritis progresses, the lubricating cartilage and fluid are eventually destroyed, allowing the bones to rub together. This results in bone spurs around the facet joints, which can take up space in the holes between vertebrae where nerve roots exit the spine, resulting in pressure to nerve roots.

Symptoms

Patients with Facet Joint Syndrome exhibit difficulty twisting and bending. Pain, numbness, and muscle weakness will affect different parts of the body depending on which nerves are being affected by facet joint syndrome.
Those with Facet Joint Syndrome in the cervical spine (neck) may have to rotate their entire bodies to look left or right, instead of simply turning their heads. Depending on which nerves are affected or have pressure against them in the cervical spine, patients can have symptoms in the neck, shoulders, arms and/or hands.
Facet Joint Syndrome in the lower back, or lumbar, makes it difficult for patients to straighten or rise up out of a chair. If the affected nerves are in the lumbar spine, patients may have symptoms in their buttocks, legs, and feet.

Diagnosis

Diagnosing Facet Joint Syndrome usually begins with a complete history and physical exam. Doctors can utilize other diagnostic tests, such as X-rays, a CT scan and/or a bone scan. X-rays help determine if there are abnormalities in the spine, while a CT scan can sometimes show more detail about facet joint surfaces. Finally, a bone scan helps determine whether facet joints are inflamed.

Treatment options for Facet Joint Syndrome

Below are some standard non-surgical and surgical treatments for Facet Joint Syndrome. Your doctor can discuss recommended treatment options based on your individual needs.

Non-Surgical

Non-Surgical treatment options include:
Rest
Heat
Electrotherapy
Physical therapy
Spinal injections
Bracing
Pain management modalities
Pain medicine

Surgical

If non-surgical treatments prove ineffective, surgery may be the next option.
Surgery on the facet joint typically involves a fusion of the joint, or “arthrodesis”. The surgeon will usually join two vertebrae together by inserting several metal screws across the joint. Bone grafts, typically removed from the pelvic bone next to the SI joint, may also be placed around the joint to help fuse it.

AN INNOVATIVE SOLUTION

The DenerveX^® Procedure

The DenerveX^® system is an innovative, minimally invasive therapy designed to provide long-lasting pain relief from chronic back pain caused by facet joint disorders.

Utilizing fluoroscopic, a type of moving X-ray guidance, the affected facet joints are identified and a small incision of 10-15 millimeters is made. Through this incision, a small procedural portal tube of 1cm in diameter is inserted through the skin to the joint. Through this procedural portal tube, the DenerveX^® device is inserted down to the facet joint and is activated.

The DenerveX^® device uses high heat and light tissue scrapping action on the back of the facet joint to disrupt the pain signals and receptors.

Once the pain signal has been disrupted, there should be a significant reduction in pain. Recovery time, after a DenerveX^® procedure, is expected to be one to two weeks.

DenerveX^® FAQs

Spinal Ostia-arthritis, or OA, is a debilitating disorder that effects millions of people globally. A significant part of OA involves the set of joints in the spine known as the facet joint. The DenerveX^® procedure is the newest approach in treating patients with Facet Joint Syndrome (FJS). It is designed to offer a long term pain relief solution for patients suffering from this disorder. Generally the patient has 4 to 6 of these joints that are affected. The procedure can be performed with sedation. Utilizing fluoroscopic, a type of moving X-ray guidance, the affected facet joints are identified and a small incision of 10-15 millimeters is made. Through this incision, a small procedural portal tube of 1cm in diameter is inserted through the skin to the joint. Through this procedural portal tube, the DenerveX^® device is inserted down to the facet joint and is activated. The DenerveX^® device uses high heat and light tissue scrapping action on the back of the facet joint to disrupt the pain signals and receptors. Once the pain signal has been disrupted, there should be a significant reduction in pain. Recovery time, after a DenerveX^® procedure, is expected to be one to two weeks.

Current treatment options for facet joint pain have not changed much in the past 40 years. They include lifestyle changes, weight reduction, injections of pain relief medications and a procedure known as Radio Frequency (RF) ablation. Unfortunately, these approaches result in only temporary relief and many times require that the patient return for follow up treatments.

Candidates for the DenerveX^® treatment are people who have had their pain isolated to the facet joint and have been unresponsive to more conservative medical approaches such as pain relievers, physical therapy and injections.

As with all surgical procedures, complications may occur when using DenerveX^®. These may include:

Local or systemic infection
Pain and tenderness at the treatment site
Burns
Paresthesia
Localized edema
Nerve pain or burning sensation originating from treatment site
Spasm of the muscles in the back

Repetitive RF ablation procedures will increase the frequency of procedural pain and complications. The DenerveX^® procedure is designed to provide longer lasting pain relief by treating the nerves and nerve receptors.

The DenerveX^® device does not damage muscles in the back and is a minimally invasive procedure so the pain should be limited. If you experience a lot of pain after your procedure, talk with your doctor about pain management.

DenerveX^® is a minimally-invasive treatment that only requires a small incision for each treatment location. Facet joints are treated with DenerveX^® on both the left and right side.

Plan to take it easy the day of your procedure and talk to your doctor about any specific restrictions for you. You may feel soreness at the treatment site for the next 2 to 4 days. Limit your activities for the first few days to those activities that do not cause you pain. Do not shower for 48 hours and no baths/soaking for one week after the procedure due to the incisions.

It is a small hand-held device synchronized with a specifically designed power generator that uses rotation and heat to treat the facet joint.

The problem joint(s) will be identified for treatment using a nerve blocking injection. Other diagnostic tools, such as MRI, may also be used by your physician. Patients who are taking aspirin or blood-thinning medications may be asked to stop days before the scheduled procedure. Discuss any medications you are taking with your physician before the procedure. Your doctor will provide you with a specific pre-procedure protocol for you to follow leading up to your procedure.

Patients are positioned with their back visible to the physician. Patients are given local anesthesia with a sedative or general anesthesia. The treatment area is identified using a type of real-time x-ray, fluoroscopy. Physicians will make a small incision to access the joint(s). The DenerveX^® system is guided to the joint and treatment is delivered for no more than 30 seconds per location.

The treatment area is identified using a type of real-time x-ray, fluoroscopy. Physicians will make a small incision to access the joint(s). The DenerveX^® system is guided to the joint and treatment is delivered for no more than 30 seconds per location.

After the procedure, bandages will be placed on your small incisions to protect against infection. Patients should expect to be dismissed within a couple of hours.

You will have some minor incisional discomfort that should resolve within a few days. Full recovery from the procedure is expected within one to two weeks.

Your facet joint pain should diminish with time. Talk to you doctor about your specific case, what you can expect for pain relief and how to proceed with your regular activities.

Why DenerveX®?