An experimental hydrogel formulation called Hydrafil™ has demonstrated significant potential in relieving chronic low back pain caused by degenerative disc disease (DDD), according to a recent study presented at the Society of Interventional Radiology Annual Scientific Meeting in Boston. The study, conducted on humans for the first time, found that Hydrafil™ provided safe and effective relief for chronic low back pain.
Degenerative disc disease is a common medical condition and a leading cause of chronic low back pain. As people age, their spinal discs, which provide cushioning and flexibility, can become dry, thin, cracked, or torn, resulting in pain and limited motion. By the age of 60, most individuals experience some level of disc degeneration.
Hydrogels have been utilized for the treatment of DDD for several years, but this particular study represents the first application of this specific gel in human subjects. The gel used in the study is a second-generation hydrogel developed by ReGelTec, Inc., and it received FDA’s breakthrough device designation in 2020, enabling expedited review due to early evidence suggesting its potential as a more effective treatment for a serious condition compared to existing options.
Twenty patients with chronic DDD low back pain, ranging from 22 to 69 years old, participated in the study. These individuals had experienced pain levels of four or higher on a 10-point scale and had not found significant relief from conservative care measures such as rest, analgesics, physical therapy, and back braces.
During the procedure, the patients were sedated, and the gel was heated to transform into a thick liquid. Using fluoroscopic imaging for guidance, researchers injected the gel directly into the affected discs using a 17-gauge needle. The gel-filled cracks and tears in the discs, adhere to both the center and outer layer of the disc.
After a six-month follow-up, all participants reported a significant reduction in low back pain, with average self-reported pain levels dropping from 7.1 to 2.0 on a scale of zero to 10. The patients also experienced notable improvements in physical function, as measured by a questionnaire assessing the impact of low back pain on their ability to carry out daily activities. The average scores on this questionnaire decreased from 48 to 6.
Lead author Douglas P. Beall, MD, FSIR, chief of radiology services at Clinical Radiology of Oklahoma, expressed optimism regarding the potential of this procedure as a promising treatment for chronic low back pain when conservative care options have proven inadequate. He highlighted the ease of administering the gel, the absence of open surgery, and the simplicity of the procedure for the patient.
Dr. Beall emphasized the lack of effective treatments for degenerative disc disease beyond conservative care, stating that surgery is statistically no more effective than conservative measures and can potentially worsen the condition. He also noted that nerve ablation is appropriate for only a limited number of patients, while existing hydrogels, inserted as soft solids through an incision, can dislodge if not skillfully placed.
The significant aspect of this study lies in the inadequacy of current treatments for DDD, such as surgery or nerve ablation, for the majority of patients. Additionally, existing hydrogels can pose insertion challenges and may not offer sufficient relief.
While the study is still in its early stages, further research is required to confirm the safety and effectiveness of this hydrogel. Dr. Beall pointed out several advantages of the hydrogel used in the study over other DDD treatment options. Its liquid state when heated allows easy flow into the disc space without requiring an incision, making the procedure less invasive and reducing the risk of complications.