Clinical Study Of a Micro-Implantable Pulse Generator For The Treatment of Peripheral Neuropathic Pain
This post market study is being conducted to document the comparative effectiveness and safety of peripheral nerve stimulation plus conventional medical management versus conventional medical management alone in the treatment of chronic, intractable peripheral neuralgia of post-traumatic or post-surgical origin. This is a prospective, minimal risk, multi-center, randomized control trial.
• 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):Post-surgical/post-traumatic peripheral neuralgia including but not limited to pain due to peripheral nerve injury, post-surgical scar formation, nerve entrapment; Mononeuropathy, specified or unspecified or in diseases classified elsewhere; Other neuralgia or neuropathic pain; Osteoarthritic pain.
• 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.
• Subject is psychologically qualified to receive a peripheral nerve stimulator as per the clinician's standard clinical practice and judgment and does not have clinically relevant psychological condition(s) that would interfere with their ability to accurately report outcomes or complete study procedures.
⁃ Subject has demonstrated the ability to appropriately place the adhesive clip in the location where the IPG is most likely to be implanted. Alternatively, subject is able to appropriately use the relief belt and/or limb cuff to keep the Therapy Disc in place.