Jun 12 2022 10:39
An experimental formulation of hydrogel, injected into spinal discs, has been shown to be safe and effective in relieving chronic low back pain caused by degenerative disc disease (DDD) or lumbar disc herniation, according to new research to be presented at the Society for Interventional Radiology’s annual scientific meeting, in Boston.
According to Neuroscience News, hydrogels have been used for a number of years to treat degenerative spondylosis, but the current study is the first test of Hydrafil gel specifically in humans, which, after six months of use, significantly reduced lower back pain in people. All study participants. The average, self-reported pain level decreased from 7.1 to 2.0 on a scale of 0 to 10, and participants also experienced significant improvement in physical performance after pain prevented patients from being able to perform normal activities.
“If these findings are confirmed in further research, this procedure may be a very promising treatment for chronic low back pain,” said study lead author Douglas Beal, chief of conservative therapy at Oklahoma Clinical Radiology Services. It does not require open surgery, and the patient does not suffer when injecting.”
The Hydrafil gel used in this study is a second generation hydrogel developed in 2020, and has been designated an Innovative Tool by the FDA, which allows for a quick review when early evidence suggests that an experimental product may provide a more effective treatment. Effectiveness of current treatment options to save patients from a serious condition.
The team of researchers enrolled 20 patients, ranging in age from 22 to 69, with chronic low back pain. Each described their pain as four or higher on a 10-point scale. None of them have ever had more than mild relief from conservative care, which includes rest, analgesics, physical therapy, and back supports.
Patients were anesthetized upon injection, and the gel was heated to a thick liquid. Guided by fluoroscopy, the researchers used a 17-gauge needle to inject the gel directly into the affected discs, where the gel was distributed in the cracks and tears to adhere to the center of the vertebra and the outer layer.
“There are really no good treatments for degenerative disc disease, or a lumbar herniated disc, apart from conservative care,” Dr. Bell said, noting that “statistically, surgical intervention is no more effective than conservative care and can even make matters worse. The nerve is suitable for only a small number of patients; while the hydrogels, which are currently in use and are commonly used, are inserted through an incision as a soft solid material, they can be dislodged if the surgeon is not skilled in placing them.”
“The innovative injectable gel, which does not require an incision in the vertebrae, leads to an increase in the entire vertebra and restoration of its structural integrity, which was not possible before,” Dr. Bell added.
Source: agencies
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