Bioness® StimRouter™ Neuromodulation System for Chronic Pain Therapy

Inclusion Criteria

• Adults (≥ 22 years) suitable for an implanted electrode for pain relief.
• Subjects who are able to give informed consent and to understand and comply with study requirements.
• Subjects who have severe intractable chronic pain of peripheral nerve origin associated with post traumatic/post surgical neuralgia for ≥ 3 months (i.e., intractable to pain medication).
• Subjects who are able to tolerate skin surface stimulation (TENS).
• Subjects who have a worst chronic pain level in the last 24 hours ≥ 5/10 (on 0-10 NRS) where such pain is attributable to a lesion or disease of the somatosensory nervous system.
• Subjects who are on a stable dose of pain medications for at least four weeks prior to screening and willing and able to maintain an equivalent dosage of their current pain medications from randomization to 3-month follow-up.

Exclusion Criteria

• Subjects who are not willing and able to maintain stable dosages of their pain medications from randomization to 3-month follow-up.
• Subjects with a pain condition that could be confused with their peripheral neuropathic pain or that is more severe than their peripheral neuropathic pain.
• Subjects who, for implantation in the trunk, have an implanted demand-type cardiac pacemaker or defibrillator.
• Subjects who have a metal implant in the area for StimRouter implantation without Sponsor approval. Maintain a minimum separation distance of 6 inches (15 cm) between the StimRouter system and all other active implanted devices and metallic implants.
• Subjects who require, or are likely to require, diathermy at the implant site.
• Subjects who require, or are likely to require, therapeutic ultrasound at the implant site.
• Subjects who have a cancerous lesion present near the target stimulation point or near to where the StimRouter user patch will adhere.
• Subjects who are known or suspected to have a nickel allergy.
• Subjects with bleeding disorders or active anticoagulation that cannot be stopped for a few days close to the time of the surgical procedure.
• Subjects who decline to provide written consent or follow-up.
• Subjects who are pregnant, plan on becoming pregnant, or are breastfeeding during the study period. Subjects who are female of child-bearing potential must have a negative pregnancy test at baseline visit and, if sexually active, must be using a medically acceptable method of contraception for the duration of the study participation.
• Subjects who have an active systemic infection or are immunocompromised.
• Subjects who have an active or existing skin disorder or irritation, which, at the physician's discretion, precludes the use of skin gel electrodes.
• Subjects who currently require or are likely to require Magnetic Resonance Imaging (MRI) within the MRI exclusion zone: the entire StimRouter lead must be at least 50 cm from the center of the MR system's bore (the iso-center) and at least 16 cm outside of the MR coil measured from the edge of the MR coil.
• Subjects who have a history of adverse reactions to local anesthetic (e.g., lidocaine).
• Subjects who are participating in any other study that could affect the outcome of the StimRouter study, such as a spinal stimulation study, without Sponsor approval.
• Subjects who are in litigation or who have pending or an active worker's compensation claim.
• Subjects with less than one year of life expectancy.