MiniStim PNS for Chronic Knee Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a prospective, multi-center, randomized, study in which 300 evaluable subjects will be randomized 1:1 to receive active or delayed therapy with Moments PNS. Subjects in the Delayed group will start with therapy at 3-month visit follow up. The primary endpoint is a \>50% pain relief at 3-months as measured by the Visual Analog Scale (VAS) without increase in baseline pain medications, with additional measurements assessed at 3, 6, 9, 12, 24, and 36-months.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that pain relief is measured without increasing baseline pain medications, so you may need to maintain your current dosage.
Is MiniStim PNS safe for treating chronic knee pain?
How is the MiniStim PNS treatment different from other treatments for chronic knee pain?
The MiniStim PNS treatment is unique because it uses electrical stimulation of peripheral nerves to block pain signals, offering a minimally invasive and convenient option for managing chronic knee pain. Unlike some other treatments, it is wirelessly controlled and can provide sustained pain relief without significant complications.23678
What data supports the effectiveness of the treatment Moventis PNS, MiniStim PNS, Moments PNS, Peripheral Nerve Stimulation for chronic knee pain?
Peripheral nerve stimulation (PNS) has been shown to effectively reduce pain in various conditions, including chronic knee pain and other types of chronic pain. In one case, a patient with severe knee pain from osteoarthritis experienced significant pain relief using PNS on specific knee nerves. Additionally, studies on similar PNS treatments for other types of pain, like peripheral neuropathic pain, have shown substantial pain reduction and improved quality of life.236910
Are You a Good Fit for This Trial?
This trial is for adults over 18 with chronic knee pain lasting at least three months, a VAS score above 5, and who've had temporary relief from nerve diagnostics. Candidates must be able to give consent, follow procedures, operate the device, and not have had recent knee surgery or anatomical issues affecting device placement.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive MiniStim PNS therapy, with active group starting immediately and delayed group starting at 3-month visit
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Moventis PNS
Moventis PNS is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
MiniStim LLC
Lead Sponsor
Micron Medical Corporation
Lead Sponsor
Uro Medical Corporation
Lead Sponsor