Stopped: Protocol proved too cumbersome. Consequently, only one one patient enrolled, and completed.
United States1 participantsStarted 2013-10
Plain-language summary
To explore the optimal stimulation parameters and locations for sub-perception programming in patients with previously implanted spinal cord stimulation systems for the treatment of chronic back and/or leg pain.
Who can participate
Age range22 Years – 85 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Primary pain complaint of persistent or recurrent low back and/or leg pain, with or without leg pain, for at least 180 days prior to Baseline.
* Received a Boston Scientific SCS System with active contacts located between superior endplate of T7 and the inferior endplate of T10 with a minimum of three active contacts within this anatomical area.
* No back surgery within 180 days prior to Baseline.
* Has had stimulator "on" (activated or operational) for at least 36 hours prior to Baseline evaluation.
* Average low back and/or leg pain intensity, during the position/activity which routinely causes worst pain, of 5 or greater on a 0-10 numerical rating scale without neurostimulation.
* If taking prescription opioids for primary chronic pain complaint (low back and/or leg pain), must have been on a stable prescription (same drug(s) and dose(s)) for 30 days prior to Baseline
* Consumed an average total daily morphine equivalent of ≤300 mg during the 30 days prior to Baseline
* Willing and able to comply with all protocol-required procedures and assessments/evaluations (e.g. willing to comply with opioid prescription lock throughout the study, changes to the stimulation parameters, complete twice-daily diary)
* 22 years of age or older when written informed consent is obtained
* Able to independently read and complete all questionnaires and assessments provided in English
* Subject signed a valid, IRB-approved informed consent form (ICF) provided in English
…
What they're measuring
1
Visual Analog Score (VAS)
Timeframe: 32 days
Trial details
NCT IDNCT01976598
SponsorAlgos Clinical Development Thomas L. Yearwood, MD, PhD