A prospective, randomized, multi-centered crossover study to evaluate the effects of percutaneously inserted spinal cord stimulation: Comparing 8 electrodes with 16 electrodes
Brain & Nerve
Timothy Downing, MD
UC Irvine Medical Center
This study is designed as a prospective, randomized, multi-centered, cross over study to evaluate the effects of percutaneously inserted spinal cord stimulator comparing 8 electrodes with 16 electrodes for approximately 6 months duration. A maximum of 100 patients will be enrolled from a maximum of 10 sites with an anticipated enrollment of 15 patients from UC Irvine Medical Center. Each patient will be randomized in a 1:1 ratio in two (2) groups, Group A or B.
Patients enrolled in this study must meet the following inclusion criteria:
- The Patient will be asked to provide informed consent to participate in the study
- The Patient’s significant other will be asked to fill out a questionnaire
- The Patient has been diagnosed with chronic pain for at least 6 months
- The Patient has pain located in the back and at least one leg with most of the pain be located in the patient’s back
- The Patient has been approved as an implant candidate for Spinal Cord Stimulation
- The Patient’s age is 18 years old or older
- The Patient has a Visual Analog Scale (VAS) score of seven or above
There will be total of 7 visits over 6 months all but two are anticipated to be standard of care for nerve stimulator implantation.
It is not possible to predict whether or not the patient will gain any personal benefit form participating in this study. This study may aid in the treatment of the patient’s chronic pain and the study may identify which lead configuration is more effective in that treatment. If the patient’s pain level can be reduced and controlled they may also be able to improve their quality of life.
Patients will be compensated $15.00 per visit for travel. There is once screening visit and seven scheduled visits during the study period for a total of $120.00.
Sara (Sally) Clack, Department of Anesthesiology