Low back pain: an effective injectable gel in the intervertebral discs?

Hydrogels have been known for several years to treat degenerative disc disease in the back.

But a new type of hydrogel would do better. In any case, this was reported by American researchers who tested its experimental formula in a clinical study, and whose results were presented at the annual meeting of the Interventional Radiology Society, which is held in Boston until to June 16.

This hydrogel has been shown to be “effective and safe”, according to the researchers, in providing significant and lasting relief for patients suffering from chronic low back pain caused by degenerative disc disease.

What is degenerative disc disease?

Degenerative disc disease is the leading cause of chronic low back pain, one of the most common medical conditions in the world. It corresponds to disc degeneration: the intervertebral disc, which has the function of separating the vertebrae, gradually deteriorates, no longer being able to fulfill its mission.

The intervertebral discs, when healthy, cushion the vertebrae of the spine to facilitate its movement and flexibility. With advancing age, they may become thinner, crack or tear, causing pain and/or loss of mobility.

Reduced pain

To test this gel, the research team recruited 20 patients aged 22 to 69, suffering from chronic low back pain with disc degeneration. Each volunteer estimated their pain at 4 out of 10 at least, the average turning around 7 on the pain scale.

Asked about the care usually followed, none of them described more than a “mild relief“of her pain, whether with rest, painkillers, physiotherapy and back braces.

An injection through the skin

To treat the patients, the researchers used fluoroscopic imaging to guide them in their gesture. The gel was heated and then injected by syringe directly into the intervertebral discs, where it filled the cracks and tears.

“We really don’t have good treatments for degenerative disc disease, other than conservative care.“, explains Dr. Douglas P. Beall, co-author of this study, chief of the radiology department at the Oklahoma clinic.

“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 explains.

Significant improvement in pain

Six months after the injection, the volunteers noted a marked improvement in their pain. On the pain scale, their rating fell from 7 to 2. Ditto with the questionnaire on their physical function and the impact of low back pain, where the results drop from 48 to 6, in terms of the ability to carry out 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 with conservative care, added Dr. Douglas P. Beall. The gel is easy to administer, requires no open surgery and is a minimally invasive procedure for the patient.”

A revolutionary device, according to the FDA

The gel used in this study, called Hydrafil™, is a second-generation hydrogel developed by the American company ReGelTec, Inc.

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In 2020, it received FDA Breakthrough Device Designation, which allows for expedited review when early evidence suggests an investigational product may provide a more effective treatment than the current option for treating a serious and debilitating disease.

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