Patient Experience Comparing Tonic Vs. Burst Spinal Cord Stimulation For Chronic Pain

An Evaluation Study of Patient Experience Comparing Tonic Vs. Burst Spinal Cord Stimulation For Chronic Pain

Researchers are evaluating if subjects who have already experienced tonic spinal cord stimulation would have a better pain relief status with burst spinal cord stimulation.

The study is a controlled trial with subjects that have an already-implanted SCS device (Eon Mini™) and are not satisfied with their pain relief status. As part of medical standard of care, patients with already-implanted Eon family tonic implantable pulse generators (IPGs) have the opportunity to experience burst stimulation for 30-Day Trial FDA approved. The aim of the study record patients experience during the 30-Day Trial using standard questionnaires.

Inclusion Criteria:

• Males and females ≥18 years-old
• Diagnosed with chronic pain
• Have an already-implanted Eon Family IPG for a minimum period of 6 months
• Are interested in trying burst technology by reprograming their IPG for 2-3 weeks according to the 30-Day Trial standard of care
• Signed informed consent

Exclusion Criteria:

• Subject's overall Beck Depression Inventory II Score is >24 or has a score of 3 on question 9 relating to suicidal thoughts or wishes at the screening visit; If subjects scores indicate suicidal thoughts, subject is going to be evaluated further if they will be subjects to Baker's act
• Subject is currently receiving, applying or considering seeking disability payments, workers compensation, or is involved in disability litigation
• Subject has an infusion pump or any other implantable neurostimulator device
• Subjects with a separate, concurrent, clinically significant or disabling chronic pain problem that requires additional medical or surgical treatment
• Subject's pain originates from peripheral vascular disease
• Subject is immunocompromised
• Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection
• Subject has history of cancer requiring active treatment in the last 6 months
• Pregnancy