More than 20,000 patients have been treated with a minimally invasive procedure designed to relieve pain from lumbar stenosis.
Now, one company is using Fitbits in a trial to measure improvements in mobility and opioid use after its mild procedure.
Lumbar spinal stenosis is a narrowing of the spinal canal that happens as we age, sometimes making it painful to stand and walk. Now, doctors are using Vertos Medical’s minimally invasive Mild procedure to treat patients, and a brand new clinical trial is using popular technology to track improvement in mobility.
Just walking used to worry Ronnie Turner. He says numbness and pain from his lumbar spinal stenosis restricted his usually active lifestyle by 50 percent.
“I wanted help, and I wanted to be where I could do things with my grandkids and my son,” he said.
Ronnie had the Mild procedure. His doctor used contrast to find the narrowing, then, through a tiny incision, removed small pieces of bone and ligament. A fluoroscope showed when the canal was open.
Dr. Vance Johnson says there's no guesswork with the Mild procedure.
“We can see while we’re operating actually, live, while we’re operating, the canal open up and the pressure decrease,” he said.
A Band-Aid covered the incision. Ronnie was back to activity the next day.
Now, Vertos medical is running a study measuring real outcomes of its Mild procedure using Fitbits. The face is covered, so patients don’t know how they’re doing during checks at six, 12 and 24 months. But a previous study showed that standing time increased from eight to 56 minutes and walking distance from 250 to 4,000 feet.
“What we expect to see is a true improvement in the quality of life of these patients, and that's new data,” Vertos President and CEO Eric Wichems said.
Ronnie says returning to fishing is proof enough for him.
“I don’t dread the opportunity to go and do things," he said. "Those days are over. I’ll try anything!”
The motion study trial will also track opioid usage before and after the mild procedure. It’s a 20-center, randomized controlled study that should have results in about a year and a half.
TOPIC: FITBIT TRIAL FOR LUMBAR STENOSIS
REPORT: MB #4533
BACKGROUND: The lumbar spine is made up of 5 vertebrae that are in the lower back in between the ribs and the pelvis. Lumbar spinal stenosis is the narrowing of the spinal canal causing the nerves to travel through the lower back to the legs. This is mostly a degenerative condition found in those 60 and above, but it can be found in younger patients as well. The main causes of this condition are bone spurs or the discs becoming less spongy which leads to reduced disc height. This could cause symptoms, but there is a possibility they might not. Symptoms include numbness, pain or weakness in the legs, buttocks or calves, pain in one or both of the thighs, cramping in the calves while walking and in rare cases, loss of motor skills in the legs. X-rays, MRIs, and CT scans are the most common tests given to those with a possibility of lumbar stenosis. The imaging shows where bone spurs may be narrowing, or where there are damaged discs or ligaments.
(Source: https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Lumbar-Spinal-Stenosis )
TREATMENTS: There are both nonsurgical and surgical options when it comes to treating this condition. Doctors can prescribe a set of different medications such as antidepressants, pain relievers, and anti-seizure drugs to help ease the pain. Physical therapy, steroid therapy and a decompression procedure are also options to help patients avoid surgery. The steroid injections reduce the inflammation and pain. For surgery, there are many types of surgeries that can be given. A laminectomy, or decompression surgery, takes out the back part of the infected vertebrae, or the lamina. There is also laminotomy, which carves a hole in the lamina to relieve pressure, and finally, laminoplatsy is surgery through the vertebrae in the neck creating space within the spinal canal.
NEW TECHNOLOGY: There is now a new surgery that can help lumbar spinal stenosis patients. It is a minimally invasive surgery. This option removes the lamina, protecting the healthy tissue around it from damage. Dr. Vance Johnson says that the problem with other surgeries is the scars can cause more problems down the road. This procedure does not require hardware. Patients recover quickly, as compared to having to recover over months.