traitement maux de dos

Beginning of clinical trials of a hydrogel to “repair” intervertebral discs (and relieve back pain)

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Intervertebral discs, as they wear out – with age or due to excessive mechanical stress – become a source of severe back pain, known as “disc degeneration.” As there is no specific drug treatment for the disease, patients have no choice but to use painkillers, physiotherapy or surgery (as a last resort) to relieve the pain. A new injectable hydrogel has recently received the very rare distinction of “revolutionary device” from the Food and Drug Administration (FDA). It works by filling in the cracks in the affected disks, in order to restore (at least in part) their functional damping role. Preliminary clinical trials are promising: their self-reported pain levels have been significantly reduced.

Located between the vertebrae, the intervertebral discs play a key role in the flexibility of spinal movements and intervertebral cushioning. With age (or under excessive mechanical stress), they gradually wear out and “dry out,” gradually losing much of the water that makes them up. As a result, disks can no longer perform their mechanical functions.

Disc degenerative pathologies progress slowly and cause relatively severe back pain over time. In the most severe cases, they affect mobility and sometimes completely immobilize the patient (due to pain).

As it dries, the discs lose thickness and the vertebrae get closer. Sometimes nerves are compressed. As there is no more damping, these nerves then become much more sensitive to shocks (when walking, running or jumping) and cause pain. The loss of disc thickness is the main cause of the loss of size of the elderly.

If until recently it was believed that the disease was mostly common in the elderly, studies actually show that more and more people (even young people) are suffering from it. According to the WHO, back pain affects almost 80% of the world’s population. In the case of disc degeneration, once the deterioration has reached an advanced stage, where the pain becomes unbearable, surgery is the only solution.

Hydrafil, ReGelTec’s new hydrogel, may revolutionize research into degenerative pathologies of the intervertebral discs, as it would do without surgery. Thanks to FDA recognition, “ This designation will allow us to deploy clinical trials in the United States more quickly and expand our clinical trials, building on the promising results of the early feasibility study. “, Assures in a press release Douglas Beall, chairman of the company’s medical advisory board.

A gel that fills cracks

In preliminary clinical trials, the company recruited 20 patients aged 22 to 69 years with chronic low back pain due to disc degeneration. Their reported pain level was greater than or equal to 4 on a scale of 1 to 10 at the beginning of the trials. In addition, all patients reported only mild relief with conventional therapies.

For clinical trials, the hydrafil was first heated to form a thicker fluid and then injected (percutaneously and under local anesthesia) into the nuclei of the affected intervertebral discs. Once cooled to the same temperature as the body, it solidifies by filling the cracks in the disc and forming a kind of implant. By restoring the functional thickness of the disc, the biomechanical properties of the vertebral segment are recovered and the pain is relieved.

After a six-month follow-up, all participants reported being significantly relieved and more mobile, with an average pain level ranging from 7.1 to 2.0. In a questionnaire on how the pain affected their daily tasks, the average score went from 48 to 6. In addition, patients were able to get up and walk after only one to two hours after the injection, and most were allowed to return home.

The hydrogel will need to be tested on more patients before it can actually prove its potential, but “ If these results are confirmed by further research, this procedure could be a very promising treatment for chronic low back pain in those who have found insufficient relief from conventional care. », concluded Beall.

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