A recent secondary analysis of a large, randomized, placebo-controlled study involving over 1,000 participants has revealed that AppliedVR's RelieVRx device provides substantial relief for patients suffering from high-impact chronic pain (HICP). The study, which focused on individuals with chronic low back pain (cLBP) and at least one major activity restriction, demonstrated that RelieVRx led to clinically meaningful reductions in both pain intensity and pain interference, particularly in the HICP group.
The findings, announced by AppliedVR, indicate that the FDA-authorized RelieVRx device is effective for both HICP and lower-impact chronic pain (LICP) patients. However, HICP patients experienced greater improvements. Notably, 70% of HICP patients were reclassified as LICP patients by the end of the treatment, with 67% maintaining this improved status 12 months after treatment.
Impact on Healthcare Costs and Patient Well-being
These results are significant for healthcare payers and providers, as HICP populations are often more expensive to treat and report more severe pain, mental health issues, and difficulties with self-care. The study suggests that RelieVRx could reduce healthcare utilization and lower economic burdens. For providers, VR therapy offers a potentially more effective treatment option for patients with the most severe pain.
"Finding that we can move patients from high-impact to low-impact pain is very notable because it means we can help them get back to the activities that severe pain can interfere with," said AppliedVR Chief Science Advisor Dr. Beth Darnall. She further explained that the skills-based VR program trains skills and habits through emotional and behavioral learning centers in the brain, enabling patients to self-manage the physiological and psychological impact of chronic pain.
About RelieVRx and AppliedVR
The RelieVRx program is an adjunctive pain management tool based on evidence-based principles for treating cLBP. It is the first FDA-authorized VR therapy for this condition and promotes neuroplasticity, helping patients develop long-term pain management skills. Patients self-administer the device at home, completing 56 sessions averaging six minutes each.
"Among the mountain of clinical evidence we've gathered over the years, these findings definitely represent some of the most important. Pain providers will tell you that HICP patients are often the most difficult to treat. So for researchers to find evidence that RelieVRx may be positively affecting that group of patients is a strong indicator that we can both improve the quality of life for patients and potentially reduce the total cost of care associated with those patients," said AppliedVR Co-founder and CEO Matthew Stoudt.
Market Access and Availability
RelieVRx has received a unique code and final pricing determination from the Centers for Medicare and Medicaid Services (CMS). It has also been added to the Department of Veterans Affairs' Federal Supply Schedule (FSS), Defense Logistics Agency's Electronic Catalogue for Medical Supply Chain (ECAT), and the Department of Defense's Distribution and Pricing Agreement (DAPA), streamlining purchases for government customers. AppliedVR has also secured an expanded contract with the U.S. Department of Veterans Affairs, extending access to RelieVRx to more veterans.
Chronic pain is a significant economic burden, costing the U.S. an estimated $635 billion annually and contributing to the opioid crisis. Over 72 million Americans suffer from chronic low back pain, a leading cause of disability. AppliedVR is pioneering immersive therapeutics (ITx) to address intractable health conditions, with RelieVRx being its flagship VR-based, prescription therapeutic for cLBP.
