N/A
N=40
Optimal Stimulation Programming for Spinal Peripheral Neuromodulation
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT02346383 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Numeric Rating Scale (Pain) — 5.2; 5.2; 5.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- preset program (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Carolinas Center for Advanced Management of Pain
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numeric Rating Scale (Pain) |
5.2; 5.2; 5.3 | — |
| SECONDARY Percent Pain Relief- Subject Self-reported Percentage of Relief With Each Program. |
52; 46; 46 | — |
Summary
To determine the best parameters with various leads to cover back and leg pain and provide best pain relief
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02346383). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.