FAIRFAX, Va. — A new experimental form of hydrogel has proven both safe and effective when it comes to relieving chronic lower back pain caused by degenerative disc disease (DDD).
According to a new study, doctors can inject the new gel right into a patient’s spinal discs.
After six months of treatment, each patient involved reported feeling significantly less pain. On a scale of one to 10, pain among back pain sufferers declined from an average self-reported pain score of 7.1 to just 2.0. Additionally, the patients reported improved physical functioning; average scores fell from 48 all the way down to six on a questionnaire measuring how much lower back pain hindered their ability to do normal tasks.
“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,” says lead study author Douglas P. Beall, MD, FSIR, chief of radiology services at Clinical Radiology of Oklahoma, in a media release. “The gel is easy to administer, requires no open surgery, and is an easy procedure for the patient.”
Filling in problem areas in the discs
Scientists call the new gel Hydrafil™ — a second-generation hydrogel developed by ReGelTec, Inc.
In 2020, ReGelTec received the FDA’s “breakthrough device designation.” This distinction allows for an expedited review for cases in which the early evidence indicates a new, experimental product may provide even better treatment than currently available options.
A total of 20 patients enrolled (ages 22-69), all with DDD lower back pain. Each volunteer described their pain to researchers as at least a four or higher on the 10-point pain scale. No participant had enjoyed anything more than “mild relief” from conservative care options (rest, back braces, analgesics, and physical therapy).
Study authors sedated each patient for the operation and then heated the gel into a thick liquid. Using fluoroscopic imaging, the team used a 17-gauge needle to inject the gel directly into the affected discs. Upon injection, the gel filled in any cracks and tears, adhering to the disc’s center and outer layer.
“We really have no good treatments for degenerative disc disease, aside from conservative care,” Dr. Beall adds. “Surgery is statistically no more effective than conservative care and can potentially make things worse; nerve ablation is appropriate for only a few patients; and existing hydrogels are inserted through an incision as a soft solid, which can pop out of place if you’re not highly skilled in placing it.”
“Because this gel is injectable, it requires no incision, and it augments the whole disc, restoring its structural integrity, which nothing we have currently can do,” he concludes.
The researchers are presenting their findings at the Society of Interventional Radiology’s 2022 Annual Scientific Meeting.