Some of the criteria that you must meet in order to be considered for participation include:
- You are between 18 and 80 years of age at the time of enrollment.
- You have a diagnosis of post-surgical or post-traumatic peripheral neuralgia, mononeuropathy, other neuropathic pain or osteoarthritic pain in one of the following areas: low back, shoulder, knee or foot/ankle.
- You are willing to meet all of the study requirements, including compliance with the study procedures and completion of all study visits.
- You have pain that is stable (non-escalating) for 60 days prior to enrollment.
- You are receiving some medical treatment (also known as conventional medical management or CMM) for your peripheral nerve pain; any pain medication must be stable in terms of use and dosage for 30 days prior to enrollment.
- You, in the clinician’s medical judgement, are a good candidate for Nalu treatment and to participate in this study.
Key Exclusion Criteria
In order to be considered for participation, you cannot have any of the following conditions:
- An active implantable medical device such as a drug pump, spinal cord stimulator, peripheral nerve stimulator, sacral nerve stimulator, deep brain stimulator, and/or cardiac pacemaker.
- A previously failed peripheral nerve stimulation (PNS) or spinal cord stimulation (SCS), or dorsal root ganglion (DRG) therapy (trial or permanent implant).
- A diagnosis of complex regional pain syndrome (CRPS) or painful diabetic neuropathy.
- Participating in another clinical study.
- Be allergic or sensitive to materials of the Nalu device or cannot tolerate the wearable aspect of the device.
- Have pending or ongoing legal issues (including unresolved worker’s compensation claims or equivalent) or other conflicting secondary gain issues related to your chronic pain condition.
- Have uncontrolled depression or other psychiatric disorders.
- Are pregnant.
- Are unable to read or write in English, or unable to give informed consent.
There are other criteria which the study staff will discuss with you.