Wireless Neuromodulation for Chronic Knee Pain
Trial Summary
What is the purpose of this trial?
To demonstrate the potential benefits and risk of active sub-threshold stimulation in the treatment of chronic knee pain as compared to subjects that did not have active stimulation. Improvement will be assessed in relation to the clinical outcome measures of pain, with primary endpoint; Pain relief rate as measured by the number of subjects with greater or equal to a 50% decrease in pain on the visual analog scale, comparing baseline to the 1-month follow-up.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have had recent invasive knee procedures like steroid injections within 2 weeks or other treatments like radiofrequency within 4 weeks before joining.
What data supports the effectiveness of the treatment Wireless Neuromodulation for Chronic Knee Pain?
Research shows that peripheral nerve stimulation (PNS), a component of wireless neuromodulation, has been effective in reducing chronic knee pain and improving quality of life. Studies have reported significant pain relief and reduced opioid use in patients with chronic knee pain after PNS therapy.12345
Is wireless neuromodulation safe for treating chronic pain?
How is the Wireless Neuromodulation treatment for chronic knee pain different from other treatments?
Wireless Neuromodulation for chronic knee pain is unique because it uses a minimally invasive, wireless device to stimulate specific nerves, providing pain relief without the need for surgery or the side effects of medications. This approach is less invasive than traditional surgical options and avoids the widespread tingling sensation often associated with conventional spinal cord stimulators.13569
Eligibility Criteria
Adults over 18 with chronic knee pain from osteoarthritis (Grade II or III), who've tried at least two other treatments like physical therapy or NSAIDs without success. Candidates should have had temporary relief from a nerve injection and be psychologically fit for implant therapies. Exclusions include severe psychiatric disorders, certain medical conditions, morbid obesity, and those with recent knee surgery.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Diagnostic Injection
A diagnostic injection is performed to assess temporary pain relief
Trial Implant
Participants undergo a 7-day provisional test period with a trial stimulator
Permanent Implant
Permanent electrode implantation for those with >50% pain relief during trial
Randomization/Blinding
Participants are randomized to active or sham stimulation for up to 30 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Remote Follow-up
Remote follow-up calls to assess long-term pain relief and adverse events
Treatment Details
Interventions
- Wireless neuromodulation
Wireless neuromodulation is already approved in United States for the following indications:
- Chronic knee pain
- Knee osteoarthritis
- Total knee replacement cases
Find a Clinic Near You
Who Is Running the Clinical Trial?
Curonix LLC
Lead Sponsor
Stimwave Technologies
Lead Sponsor
Florida Joint Pain Institute
Collaborator
Advanced Spine and Pain
Collaborator
Premier Pain Treatment
Collaborator
Austin Orthopedic Institute
Collaborator
Kettering Health
Collaborator
Desert Orthopaedic Institute
Collaborator
Vista Clinical Research
Collaborator
Southern pain and Spine
Collaborator