NEW YORK (Reuters Health) - An experimental hydrogel injected into spinal discs appears to relieve pain and improve function in patients with chronic low-back pain caused by degenerative disc disease (DDD), according to an early feasibility study.
The hydrogel was successfully and safely injected into all targeted intervertebral discs and led to "prompt and sustained statistically significant improvement in pain and function in this difficult-to-treat scenario of low-back pain associated with degenerative disc disease," reported Dr. Douglas Beall of Clinical Radiology of Oklahoma, in Edmond, at a press briefing ahead of the Society of Interventional Radiology (SIR) annual meeting.
The gel used in this study, Hydrafil, is a second-generation hydrogel developed by ReGelTec, Inc, which funded the study. In 2020, Hydrafil received the U.S. Food and Drug Administration's breakthrough device designation. Dr. Beall consults for the company.
The study included 20 adults with moderate to severe chronic low-back pain caused by DDD.
Each described their pain as 4 or higher on a 10-point scale. None had found more than mild relief from conservative care, which included rest, analgesics, physical therapy and back braces.
Guided by fluoroscopic imaging, a 17-gauge needle was used to inject the gel directly into the affected discs, where the gel filled in cracks and tears, adhering to the disc's center and outer layer.
The treatment was safe and led to a "67% reduction" in back pain, coupled with "substantial" improvement in functional capability, as evidenced by an 85% reduction in Oswestry Disability index scores, Dr. Beall told the briefing.
"If these findings are confirmed in further research, this procedure may be a very promising treatment for chronic low back pain in those who've found insufficient relief from conservative care," he added in a conference statement.
The results of ongoing pilot trials are "at least as good and comparatively a little better" than the early feasibility studies, Dr. Beall told the briefing.
SOURCE: https://bit.ly/3Q8siqa Society of Interventional Radiology annual meeting, June 11-16, 2022.
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