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New injectable gel may significantly reduce chronic low back pain – Neuroscience News

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Summary: Hydrafil, an experimental injectable hydrogel, appears to be safe and effective in reducing chronic lower back pain associated with degenerative disc disease.

Source: Interventional Radiology Society

An experimental hydrogel formulation, injected into intervertebral discs, has been shown to be safe and effective in significantly relieving chronic low back pain caused by degenerative disc disease (DDD), according to new research to be presented at the Society’s annual scientific meeting of Interventional Radiology, in Boston.

Hydrogels have been used for a number of years to treat DDD, but the current study is the first test of this particular gel in humans.

After six months, all participants in this small study reported significantly less lower back pain, dropping from an average self-reported pain level of 7.1 to 2.0 on a scale of zero to 10. They also experienced improvement of their physical function, with average scores. falling from 48 to 6 on a questionnaire to assess the impact of low back pain on patients’ inability to perform normal activities.

“If these results are confirmed by further research, this procedure may be a very promising treatment for chronic low back pain in those who have found insufficient relief from conservative care,” said lead author Douglas P. Beall, MD, FSIR, Chief of Radiology Services at Oklahoma Clinical Radiology. “The gel is easy to administer, requires no open surgery, and is an easy procedure for the patient.”

The gel used in this study, Hydrafil™, is a second-generation hydrogel developed by ReGelTec, Inc. In 2020, it received Breakthrough Device Designation from the FDA, which allows for expedited review when early evidence suggests a investigational product may provide more effective treatment than current options for treating serious illness. Dr. Beall is the company’s medical advisor.

The research team recruited 20 patients, aged 22 to 69, with DDD chronic low back pain. Everyone described their pain as four or more on the 10-point scale. None had found more than mild relief from conservative care, which includes rest, painkillers, physiotherapy and back braces.

Patients were sedated for the procedure and the gel was heated to become a thick liquid. Guided by fluoroscopic imaging, the researchers used a 17-gauge needle to inject the gel directly into the affected discs, where the gel filled the cracks and tears, adhering to the center and outer layer of the disc.

After six months, all participants in this small study reported significantly less lower back pain, dropping from an average self-reported pain level of 7.1 to 2.0 on a scale of zero to 10. The image is in the public domain

“We really don’t have any good treatments for degenerative disc disease other than conservative care,” Dr. Beall said.

See also

This shows a diagram of the study

“Surgery is statistically no more effective than conservative care and can potentially make things worse; nerve ablation is only appropriate for a few patients; and existing hydrogels are inserted through an incision as a soft solid, which can slip out of place if you are not highly skilled in placing it.

“Because this gel is injectable, it requires no incisions, and it augments the entire disc, restoring its structural integrity, which nothing we currently have can do,” he said.

Degenerative disc disease is the leading cause of chronic low back pain, one of the most common medical conditions in the world. Healthy discs cushion the vertebrae in the spine, facilitating movement and flexibility. With normal aging, however, they can become dry, thin, cracked, or torn, causing pain or loss of movement. By age 60, most people have at least some disc degeneration.

About this pain and neurotechnology research news

Author: Elise Castelli
Source: Interventional Radiology Society
Contact: Elise Castelli – Interventional Radiology Society
Image: Image is in public domain

Original research: Findings will be presented at the 2022 Society of Interventional Radiology Annual Scientific Meeting

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