Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2025-12-24 @ 12:02 PM
NCT ID:
NCT02896361
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02896361
Study Brief:
Protocol Section:
NCT02896361