NOVABLOC for Pain

(NOVABLOC TKA Trial)

This trial tests the NOVABLOC system, a new potential treatment, to evaluate its effectiveness in managing pain after knee replacement surgery for osteoarthritis patients. Participants will receive either the actual NOVABLOC treatment or a non-therapeutic sham stimulation for comparison. The trial seeks individuals with osteoarthritis undergoing knee replacement who do not regularly take strong pain medications.

As a Phase 2, Phase 3 trial, it measures the treatment's effectiveness in a larger group and represents the final step before FDA approval, offering participants an opportunity to contribute to advancing medical care.

The trial does not specify if you need to stop taking your current medications, but it does exclude people who have used chronic or long-acting opioids within 30 days of the procedure. It's best to discuss your specific medications with the trial team.

Research shows that the NOVABLOC system is being tested to manage pain after surgery, particularly for knee and shoulder replacements. Early results suggest it might provide pain relief for up to 20 days. However, researchers are still gathering detailed information about its safety in humans. Since this trial is in Phase 2 and Phase 3, some testing in humans has already occurred.

Most treatments for pain management, like NSAIDs and opioids, work by blocking pain signals or reducing inflammation after an injury or surgical procedure. But the NOVABLOC System works differently. It uses a unique stimulation technique designed to preemptively manage pain by targeting nerve pathways before surgery, specifically before a total knee arthroplasty (TKA). This approach could potentially reduce the need for post-operative pain medications and their associated side effects, offering a more proactive and less invasive way to handle pain. Researchers are excited about this because it could revolutionize pain management, offering a new level of comfort and recovery for patients.

Research shows that the NOVABLOC system, which participants in this trial may receive, can help reduce pain after surgery. In earlier studies, patients who used NOVABLOC reported significantly less pain than those who received a placebo. This technology is designed to relieve pain for more than 20 days without affecting movement or touch sensation. It also improves functional ability and reduces the impact of pain on daily activities. These results suggest that NOVABLOC could be a promising option for managing post-surgical pain.²⁶⁷⁸⁹