Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
MedtronicNeuro
This study is a multi-center, prospective, randomized (1:1) parallel-group design.
Age
22–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Subcutaneous Nerve Stimulation for Failed Back Surgery Syndrome (FBSS) Patients
