N/A
Completed N=27
Burst Optimized Stimulation Study
Source: ClinicalTrials.gov NCT02896361 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Visual Analog Scale (VAS) for Pain — 46.88; 48.60; 46.76 units on a scale
Summary
This purpose of this study is to evaluate the therapeutic efficacy of burst microdosing stimulation paradigms in patients with chronic pain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale (VAS) for Pain |
46.88; 48.60; 46.76 | — |
| SECONDARY EQ-5D |
0.59; 0.62; 0.59 | — |
| SECONDARY Subject Preference |
2; 1; 3; 1; 5; 3 | — |
| SECONDARY Subject Satisfaction |
3; 5; 7; 12; 8; 8 | — |
| SECONDARY Percentage of Participants With Adverse Events |
3.7 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has been implanted with a commercially available SJM spinal cord stimulator for controlling chronic intractable pain associated with back and/or leg pain;
- Subject has been exclusively using burst stimulation for at least three months;
- Subject is 18 years of age or older;
- Subject's pain-related medication regimen was stable in the 4 weeks prior to the screening evaluation;
- Subject agrees not to add or increase pain-related medication from enrollment through the study duration;
- Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all office visits;
Exclusion Criteria
- Subject is currently participating in a clinical investigation study that includes an active treatment arm;
- Subject is currently receiving, applying or considering seeking workers compensation, or is involved in disability litigation;
- Subject has a non SJM neuromodulation device
Data sourced from ClinicalTrials.gov (NCT02896361). 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. Informational only — not medical advice.