Clinical Study of a Micro-Implantable Pulse Generator for the Treatment of Peripheral Neuropathic Pain (COMFORT 2)

Inclusion criteria

• ✓. Subject is between 18 to 80 years of age at the time of enrollment.
• ✓. Subject would have been prescribed PNS therapy regardless of participation in this study; the use of the Nalu device must be on-label.
• ✓. Subject has been diagnosed with one or more of the conditions listed below in the low back, shoulder, knee, or foot (including ankle):
• ✓. Subject has chronic (defined as at least 6 months duration), intractable peripheral neuropathic pain, exclusive of the craniofacial region; any nociceptive pain must be less prominent than the neuropathic pain. Pain should have a predominant neuropathic component as per the investigator's clinical assessment.
• ✓. Subject should have a pain score of at least 6, in the target area of pain, as recorded on the BPI-Q5 (NRS) at screening.
• ✓. Subject is willing to cooperate with the study requirements including, compliance with the study procedures and completion of all study visits.
• ✓. Subject reported stable pain (non-escalating) for 60 days prior to signing informed consent.
• ✓. Subject is currently receiving CMM and has had stable pain medication use and dosage for 30 days prior to signing informed consent.