Subcutaneous Nerve Stimulation for Failed Back Surgery Syndrome (FBSS) Patients

SubQStim Pivotal Study: A Prospective, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Nerve Stimulation. Protocol 1666

The purpose of this study is to assess the safety and efficacy of Subcutaneous Nerve Stimulation (SQS) (also known as Peripheral Nerve Stimulation [PNS]) in the reduction of chronic, intractable post-surgical back pain in adults.

This study is a multi-center, prospective, randomized (1:1) parallel-group design.

Key Inclusion Criteria:

• Have persistent back pain for at least 6 months
• Had back surgery at least 6 months ago
• Have tried pain medications and physical therapy
• Read and understand written English or Spanish
• Male or non-pregnant female. If female of child-bearing potential, and if sexually active, must be using a medically-acceptable method of birth control during study participation
• Willing and able to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements
• Have an expected lifespan greater than 12 months

Key Exclusion Criteria:

• Have leg pain in addition to back pain.
• Currently enrolled in or plan to enroll in another drug and/or device study
• Have peripheral vascular disease, peripheral neuropathy, small-fiber neuropathy, or fibromyalgia
• Have an active systemic infection or are immunocompromised
• Will be exposed to diathermy or anticipate needing a full-body MRI scan
• Currently have an implantable cardiac pacemaker, defibrillator, or neurostimulator
• Treated with spinal cord stimulation, peripheral nerve stimulation, an intrathecal drug delivery system or requires additional back surgery