Optimal Stimulation Programming for Spinal Peripheral Neuromodulation
Status: | Recruiting |
---|---|
Conditions: | Chronic Pain, Chronic Pain |
Therapuetic Areas: | Musculoskeletal |
Healthy: | No |
Age Range: | 22 - 90 |
Updated: | 4/21/2016 |
Start Date: | September 2013 |
End Date: | June 2016 |
Contact: | Justin K Hutcheson, MD |
Email: | khutchesonmd@carolinapain.com |
Phone: | 8642956399 |
To determine the best parameters with various leads to cover back and leg pain and provide
best pain relief
best pain relief
Prospective double-blinded trial of patients already implanted with SCS to determine which
programming model best controls their back and or leg pain. Baseline visit is 2 weeks after
implant. Baseline study data is collected, program #1 is started. The visit @ week 4
collects NRS and stimulator data, changes to program #2. The visit @ week 6 collect NRS and
stimulator data, and starts program #3. The visit @ week 8 collects NRS and stimulator data.
Subject chooses their preferred program from the previous 3 and uses that for the next 12
weeks. The visit @ week 20 collects NRS and stimulator data and final study visit
information.
programming model best controls their back and or leg pain. Baseline visit is 2 weeks after
implant. Baseline study data is collected, program #1 is started. The visit @ week 4
collects NRS and stimulator data, changes to program #2. The visit @ week 6 collect NRS and
stimulator data, and starts program #3. The visit @ week 8 collects NRS and stimulator data.
Subject chooses their preferred program from the previous 3 and uses that for the next 12
weeks. The visit @ week 20 collects NRS and stimulator data and final study visit
information.
Inclusion Criteria:
- spinal cord stimulator implant within last 3 weeks
- NRS > 6
- at least 22 years old
- patients who agree not to add or increase their pain medications during the study
Exclusion Criteria:
- patients with prior spinal cord stimulators
- pregnancy
- infusion pump
- history of substance abuse or dependency in last 6 months
We found this trial at
1
site
Spartanburg, South Carolina 29303
Principal Investigator: Eugene Mironer, MD
Phone: 854-583-0053
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