Stimwave Technologies has announced the launch of its level-one FREEDOM clinical trial series—which consists of multicentre, prospective, randomised trials that monitor chronic pain patients’ responses to peripheral nerve stimulation (PNS) over time. Upon completion of this series, the study data will be aggregated to demonstrate further broad proof of efficacy with Stimwave’s Freedom PNS therapy.
FREEDOM-1 is the company’s first clinical trial (in the series) to evaluate the treatment of patients with chronic knee pain using the Stimwave Freedom PNS system. The primary endpoint consists of a reduction in pain equal to or greater than 50% based on the visual analogue scale (VAS). Secondary outcomes will be related to changes in the physical function of patients’ knees while undergoing treatment, and overall quality of life improvement, as per a Stimwave press release.
“Knee pain is one of the most prevalent forms of chronic pain experienced by patients globally and is strongly correlated with the high volumes of surgical procedures performed each year on the joint,” said FREEDOM-1’s lead investigator Standiford Helm (The Helm Center for Pain Management, Laguna Hills, USA). “Despite the surgical interventions available today to fix functional problems, a patient’s quality of life can be severely impacted by chronic pain and subsequent reductions in mobility. The Freedom PNS system offers a unique solution by addressing chronic knee pain associated with a specific peripheral nerve, at the source.”
“A key component of Stimwave’s long-term value creation strategy is to collaborate with leading centres to generate high-quality, level-one clinical data that support the appropriate use of the Freedom PNS therapy through our market-leading medical education and market access initiatives,” added Aure Bruneau, Stimwave’s CEO. “We are very excited to launch this initial FREEDOM-1 study in connection with the treatment of chronic knee pain and look forward to launching additional, similarly structured chronic pain trials as part of our larger commitment.”