Am I Eligible?

Have you tried multiple treatments for your nerve-related chronic pain with no relief? If you have severe chronic nerve pain and meet study criteria below, you may be a candidate.

Your doctor will determine if you’re a good candidate for the COMFORT clinical trial. Find an enrolled practice site near you to learn more. Find the full study criteria at https://clinicaltrials.gov/study/NCT05870124.

Key Inclusion Criteria

Some of the criteria that you must meet in order to be considered for participation include:

1. You are between 18 and 80 years of age at the time of enrollment.
2. 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.
3. You are willing to meet all of the study requirements, including compliance with the study procedures and completion of all study visits.
4. You have pain that is stable (non-escalating) for 60 days prior to enrollment.
5. 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.
6. 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:

1. 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.
2. A previously failed peripheral nerve stimulation (PNS) or spinal cord stimulation (SCS), or dorsal root ganglion (DRG) therapy (trial or permanent implant).
3. A diagnosis of complex regional pain syndrome (CRPS) or painful diabetic neuropathy.
4. Participating in another clinical study.
5. Be allergic or sensitive to materials of the Nalu device or cannot tolerate the wearable aspect of the device.
6. 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.
7. Have uncontrolled depression or other psychiatric disorders.
8. Are pregnant.
9. 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.

Contact An Enrolling Practice Near You

If you’re interested in learning more about the Nalu COMFORT Trial, please use the following form to reach out to a practice location near you for more information.