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

Source: Society for Interventional Radiology

An experimental formulation of a hydrogel injected into spinal discs has been shown to be safe and effective in substantially relieving chronic back pain caused by degenerative disc disease (DDD), according to new research presented at the Society of Interventional Radiology’s Annual Scientific Meeting to be presented in Boston.

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

After six months, all participants in this small study reported significantly less back pain – going from an average self-reported pain level of 7.1 to 2.0 on a scale of zero to 10. They also experienced greatly improved physical function, with mean scores on a questionnaire measuring the impact of back pain on preventing patients’ ability to perform normal activities falling from 48 to 6.

“If these results are confirmed with further research, this procedure could be a very promising treatment for chronic low back pain in patients who have not found adequate relief with conservative measures,” said lead author Douglas P. Beall, MD, FSIR, Chief of Radiology Services at Clinical Radiology of Oklahoma. “The gel is easy to administer, does not require open surgery and is a simple 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, allowing for expedited review when early evidence suggests an experimental product could provide a more effective treatment than current options for treating a serious condition. dr Beall is the company’s medical advisor.

The research team enrolled 20 patients aged 22 to 69 with chronic DDD back pain. Each described their pain as a four or higher on the 10-point scale. None had experienced more than mild relief with conservative management, which included rest, analgesics, physical therapy, and back supports.

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 in cracks and fissures and adhered to the center and outer layer of the disc.

After six months, all participants in this small study reported significantly less back pain – going 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, aside from conservative treatment,” said Dr. Ball.

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“Surgery is statistically no more effective than conservative treatment 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 that can pop out if you’re not very skilled at placing it.

“Because this gel is injectable, it doesn’t require an incision, and it enlarges the entire disc and restores its structural integrity, which nothing currently does,” he said.

Degenerative disc disease is the main cause of chronic back pain, one of the most common diseases worldwide. Healthy discs cushion the vertebrae of the spine, facilitating movement and flexibility. However, with normal aging, they can become dry, thin, cracked, or torn, causing pain or limitation of movement. By age 60, most people have at least some disc degeneration.

About this pain and neurotech research news

Author: Elisa Castelli
Source: Society for Interventional Radiology
Contact: Elise Castelli – Society for Interventional Radiology
Picture: The image is in the public domain

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

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