Experimental Hydrogel Improved Chronic Pain from Degenerative Disc Disease

PainRelief.com Interview with:
Douglas P. Beall, MD, FSIR
Chief of Radiology Services
Clinical Radiology of Oklahoma

Dr. Bealll

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.

Genicular Artery Embolization: A Promising Therapy for Pain Relief from Knee Arthritis

PainRelief.com Interview with:
Dr. Siddharth A. Padia, MD
Interventional Radiology
Ronald Reagan UCLA Medical Center
UCLA Santa Monica Medical Center

Dr. Padia, MD

PainRelief.com:  What is the background for this study?

Response: Osteoarthritis (OA) of the knee can be a debilitating condition with significant impact on a person’s overall quality of life. OA has historically been considered a “wear-and-tear” disease, resulting from years of stress induced cartilage degeneration. Recent data suggests that inflammation plays a role not only in the experience of pain secondary to osteoarthritis, but is a driver of OA itself. 

Genicular artery embolization (GAE) is a minimally invasive procedure where the arteries supplying the lining of the knee are selectively catheterized during an angiogram to target abnormally increased blood flow associated with knee osteoarthritis. Injection of small, microspheres results in a reduction in arterial flow, which may in turn reduce the synovial inflammation. 


PainRelief.com: What are the main findings?

Response: 40 subjects were enrolled in this trial. Technical success was achieved in 100% of subjects. Transient skin discoloration and transient mild post-procedure knee pain were common and expected. Pain scores decreased from a 8 (out of 10) at baseline to 3/10 (63% decrease) at 12 months. Twenty-seven patients (67.5%) had greater than a 50% reduction in pain scores. 

PainRelief.com: What should readers take away from your report?

Response: Genicular artery embolization is a highly promising therapy for people with knee arthritis, who are not surgical candidates or which to defer surgery. It is the first non-surgical treatment that has shown to have a significant reduction in pain with a duration of at least one year. It is minimally invasive, and most people can resume their everyday activities the evening after their procedure. 

PainRelief.com: What recommendations do you have for future research as a result of this work?

Response: This was a single arm trial, in that genicular artery embolization was not compared to other treatments. Future research needs to show a comparison to other treatments or placebo in order to prove its efficacy. Additionally, long-term result (2 and 4 years) would be beneficial to show the durability of GAE over time. 

Citation:

Abstract No. 16 Genicular artery embolization for the treatment of knee osteoarthritis: final results from a prospective investigational device exemption trial
Padia, S. et al. Journal of Vascular and Interventional Radiology, Volume 32, Issue 5, S8

https://www.jvir.org/article/S1051-0443(18)31829-3/fulltext

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