Field Shape and Amplitude Sensitivity Exploratory Study (CONTOUR Study)
Not Applicable
Terminated
- Conditions
- Chronic Neuropathic Pain in the Low Back and Legs
- Registration Number
- NCT02916498
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
The study aims to better understand how to program Spinal Cord Stimulation for the treatment of chronic low back and leg pain
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Patient Preferred Field Shape 42 days post randomization Number of participants preferring bipolar field shape and alternative field shape
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
St. Bartholomew's Hospital
🇬🇧London, United Kingdom
James Cook University Hospital
🇬🇧Middlesborough, United Kingdom
St. Bartholomew's Hospital🇬🇧London, United Kingdom