The intervertebral discs, by wearing out – with age or due to excessive mechanical stress, become sources of intense back pain, by what is called “disc degeneration”. Since there is no specific drug treatment for the disease, patients have no choice but to resort to painkillers, physiotherapy or surgery (as a last resort) to relieve the pain. A new injectable hydrogel recently received the very rare distinction of “breakthrough device” from the Food and Drug Administration (FDA). It works by filling the cracks in the affected discs, in order to restore (at least in part) their functional cushioning role. Preliminary clinical trials are promising: their self-reported level of pain was notably reduced considerably.
Located between the vertebrae, the intervertebral discs play a fundamental role in the flexibility of the movements of the spine and the intervertebral damping. With age (or under excessive mechanical stress), they gradually wear out and “dry out”, gradually losing the water that makes them up for the most part. Thus, the discs can no longer perform their mechanical functions.
Degenerative disc conditions progress slowly and cause relatively severe back pain over time. In the most serious cases, they affect mobility and sometimes completely immobilize the patient (under the effect of pain).
As they dry out, the discs lose thickness and the vertebrae come together. It sometimes happens that nerves are compressed. Since 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 also the main cause of loss of height in the elderly.
If it was believed until recently that the disease was mainly common to the elderly, studies actually show that more and more people (even young people) suffer from it. According to the WHO, back pain affects nearly 80% of the world’s population. In the case of disc degeneration, once the degradation has reached an advanced stage, where the pain becomes unbearable, surgery is the only solution.
Hydrafil, the new hydrogel from the company ReGelTec, will perhaps revolutionize the search for treatment against degenerative pathologies of the intervertebral discs, because it would make it possible to do without surgery. Thanks to FDA recognition, “ this designation will allow us to more quickly deploy clinical trials in the United States and expand our clinical trials, building on the promising results of the early feasibility study “, assures in a communiqué Douglas Beall, chairman of the company’s medical advisory board.
A gel that fills cracks
In preliminary clinical trials, the company enrolled 20 patients between the ages of 22 and 69 with chronic lower 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 start of the trials. Furthermore, all patients had reported only mild relief with conventional therapies.
For clinical testing, hydrafil was first heated to form a thicker liquid and then injected (percutaneously and under local anesthesia) into the nuclei of affected intervertebral discs. Once cooled to the same temperature as the body, it solidifies, filling the cracks in the disc and forming a sort of implant. By restoring the functional thickness of the disc, the biomechanical properties of the vertebral segment are recovered and pain is relieved.
After a six-month follow-up, all participants reported being significantly relieved and more mobile, with the average pain level dropping from 7.1 to 2.0. On a questionnaire about how the pain affected their daily tasks, the average score dropped from 48 to 6. Additionally, patients were able to stand up and walk after just one to two hours following the injection, and most were allowed to return home.
The hydrogel will need to be tested on more patients before it really proves 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 with conventional care. », concludes Beall.