Randomized Controlled Clinical Trial Expected to Validate Effectiveness of ReActiv8® Restorative NeurostimulationTM
Mainstay Medical Holdings plc Completes Enrollment in RESTORE Study
DUBLIN–(BUSINESS WIRE) – Mainstay Medical Holdings plc today announced the completion of enrollment in its RESTORE randomized clinical study of ReActiv8 for the treatment of intractable chronic low back pain. The study is designed to provide a direct comparison to optimized medical management.
Chronic low back pain is a debilitating condition that affects millions of people worldwide. It can have a significant impact on quality of life and productivity, leading to both physical and emotional distress. Mainstay Medical Holdings plc’s RESTORE study aims to evaluate the effectiveness of ReActiv8, a neurostimulation device, in providing relief for patients suffering from intractable chronic low back pain.
ReActiv8 works by delivering electrical stimulation to the nerves in the lower back, helping to restore muscle function and reduce pain. The device is implanted by a qualified healthcare professional and can be adjusted to meet the individual needs of each patient. The RESTORE study will compare the outcomes of patients treated with ReActiv8 to those receiving optimal medical management, providing valuable insights into the potential benefits of this innovative technology.
By completing enrollment in the RESTORE study, Mainstay Medical Holdings plc has taken a significant step towards validating the effectiveness of ReActiv8 in the treatment of chronic low back pain. This randomized controlled clinical trial will provide valuable data to support the use of neurostimulation technology as a safe and effective alternative for patients who have not found relief with traditional treatments.
As the results of the RESTORE study are analyzed and published, healthcare providers and patients alike will have access to evidence-based information to guide treatment decisions. If ReActiv8 is proven to be effective, it could offer new hope for individuals suffering from chronic low back pain and improve their quality of life.
How Will This Impact Me?
If you are one of the millions of people living with chronic low back pain, the findings of the RESTORE study could have a direct impact on your treatment options. If ReActiv8 is shown to be effective, it may offer a non-invasive alternative to surgery or long-term use of medication. Talk to your healthcare provider about the latest advancements in neurostimulation technology and whether it may be a suitable treatment option for you.
How Will This Impact the World?
The completion of the RESTORE study has the potential to revolutionize the treatment of chronic low back pain on a global scale. If ReActiv8 is proven to be effective, it could offer a safe and cost-effective solution for millions of patients who have not responded to traditional therapies. This could lead to a significant reduction in healthcare costs associated with the management of chronic pain and improve the quality of life for individuals around the world.
Conclusion
The completion of enrollment in the RESTORE study marks an important milestone in the evaluation of ReActiv8 as a treatment for intractable chronic low back pain. The findings of this randomized controlled clinical trial have the potential to transform the way we approach the management of chronic pain and offer new hope for individuals seeking relief. As the results are analyzed and disseminated, the impact of this groundbreaking research will be felt both by patients and healthcare providers worldwide.