Field Shape and Amplitude Sensitivity Exploratory Study (CONTOUR Study) (NCT02916498) | Clinical Trial Compass
TerminatedNot Applicable
Field Shape and Amplitude Sensitivity Exploratory Study (CONTOUR Study)
Stopped: Stopped due to a business decision
United Kingdom16 participantsStarted 2017-02-07
Plain-language summary
The study aims to better understand how to program Spinal Cord Stimulation for the treatment of chronic low back and leg pain
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Documented average low back pain intensity of at least 6 out of 10 and greater or equal than average leg pain intensity over 7 days during screening (Numerical Rating Scale)
* Stable daily pain-related medication prescription and intake of ≤100mg morphine-equivalents
* Capacity to describe and rate pain intensity, complete study measurements, and use the study device (e.g. patient remote control, charger, diary ratings) (physician discretion)
Key Exclusion Criteria:
* Presence of pain or psychological condition that in the opinion of the investigator may interfere with the subject's ability to rate their pain and communicate such ratings
* Previous Spinal Cord Stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)