Optimal Stimulation Programming for Spinal Peripheral Neuromodulation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Carolinas Center for Advanced Management of Pain
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Numeric Rating Scale (Pain)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
To determine the best parameters with various leads to cover back and leg pain and provide best pain relief
Detailed Description
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, changes to program #2. The visit @ week 6 collect NRS, and starts program #3. The visit @ week 8 collects NRS. Subject chooses their preferred program from the previous 3 and uses that for the next 12 weeks. The visit @ week 20 collects NRS.
Investigators
Eugene Mironer, M.D.
PI
Carolinas Center for Advanced Management of Pain
Eligibility Criteria
Inclusion Criteria
- •spinal cord stimulator implant within last 3 weeks
- •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
Outcomes
Primary Outcomes
Numeric Rating Scale (Pain)
Time Frame: Weeks 4, 6 and 8
0 (no pain)- 10 (worst pain imaginable)
Secondary Outcomes
- Percent Pain Relief- Subject Self-reported Percentage of Relief With Each Program.(weeks 4, 6, and 8)