traitement maux de dos

Clinical trials of hydrogel begin to ‘repair’ intervertebral discs (and relieve back pain)

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Intervertebral discs, by wear – with age or due to excessive mechanical stress, become sources of severe back pain, the so-called “disc degeneration”. Since there is no specific drug treatment for this disease, patients have no choice but to turn to analgesics, physical therapy, or surgery (as a last resort) to relieve pain. A new injectable hydrogel recently received the very rare distinction of a “breakthrough device” from the Food and Drug Administration (FDA). It works by filling cracks in the affected discs, in order to (at least partially) restore the role of functional cushioning. Initial clinical trials are promising: the level of self-reported pain has been significantly reduced.

Located between the vertebrae, the intervertebral discs play an essential role in the flexibility of the spine’s movements and the damping between the vertebrae. With age (or under excessive mechanical stress), they gradually wear out and “dry out”, gradually losing the water that makes up most of them. Consequently, the discs are no longer able to perform their mechanical functions.

Degenerative disc conditions develop slowly and cause relatively severe back pain over time. In more serious cases, it affects the movement and sometimes completely immobilizes the patient (under the influence of pain).

When they dry out, the discs lose thickness and the vertebrae clump together. Sometimes the nerves get compressed. Because there is no more damping, these nerves become more sensitive to shocks (when walking, running or jumping) and cause pain. Loss of disc thickness is also the main cause of height loss in the elderly.

If until recently it was believed that the disease was common mainly among the elderly, then in fact studies show that more and more people (even young people) suffer from it. According to the World Health Organization, back pain affects nearly 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, the new hydrogel from ReGelTec, may revolutionize the search for a treatment against degenerative diseases of the intervertebral discs, as it will make it possible to do without surgery. Thanks to the FDA’s recognition, ” This appointment will allow us to deploy clinical trials more quickly in the United States and expand our clinical trial scale, based on the promising results of an early feasibility study. Douglas Beal, chair of the company’s medical advisory board, confirms in a press release.

Crack Filling Gel

In the initial clinical trial, the company enrolled 20 patients between the ages of 22 and 69 with chronic low back pain due to disc degeneration. The reported pain level was greater than or equal to 4 on a scale of 1 to 10, at the start of the trials. Furthermore, all patients reported only mild relief with conventional treatments.

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

After a six-month follow-up, all participants reported significantly more relaxed and more mobile, with the average pain level dropping from 7.1 to 2.0. In a questionnaire about how pain affected their daily tasks, the average score was reduced from 48 to 6. Additionally, patients were able to stand and walk only 1 to 2 hours after the injection, and most were allowed to go home.

The hydrogel will need to be tested in more patients before it truly proves its potential, but” If these findings are confirmed by further research, this procedure may be a very promising treatment for chronic low back pain in those who have not found adequate relief with conventional care. Bell concludes.



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