PainRelief.com Interview with:
Douglas P. Beall, MD, FSIR
Chief of Radiology Services
Clinical Radiology of Oklahoma
PainRelief.com: What is the background for this study?
Response: Degenerative disc disease (DDD) is the leading cause of chronic low back pain and one of the world’s most common medical conditions contributing to high medical and disability costs. Healthy spinal discs act aids spine movement and distributes force which allows for spine flexibility and even distribution of the load that is placed on the spine. Each has a firm outer layer and a soft, jelly-like core. With normal aging, discs tend to become dry, thin, cracked or torn, which can cause pain and abnormal motion.
Substances called hydrogels, with biochemical similarities to the intervertebral disc designed to augment both the core and outer layer, have been used for years to help repair degenerated discs. First-generation hydrogels are placed as a soft solid, through a surgical incision, but were not simple to place and had a tendency to migrate from where they were originally placed.
For a first-in-human trial, our team conducted a prospective, single-arm feasibility study to evaluate an experimental, injectable hydrogel for safety and performance in relieving chronic low back pain caused by DDD. We used a second-generation hydrogel (Hydrafil™) developed by ReGelTec, Inc.. Unlike earlier hydrogels, it can be temporarily modified into a liquid and injected rather than placed through a small incision. In 2020, this product received FDA’s breakthrough device designation, allowing expedited review based on promising early evidence.
We recruited 20 patients, aged 22 to 69, who each described their pain as four or higher on a zero to 10 scale. None had found more than mild relief from non-surgical management, which includes rest, analgesics, physical therapy, and back braces. Patients were sedated for the procedure, and the gel was heated to become a thick liquid. Guided by fluoroscopic imaging, an interventional radiologist used a 17-gauge needle to inject the gel directly into the affected disc(s). The gel filled in cracks and tears and adhered to the disc’s core and outer layer.