Status:
WITHDRAWN
Comparison of Continuous and Burst High Frequency Spinal Cord Stimulation Paradigms
Lead Sponsor:
Rush University Medical Center
Conditions:
Chronic Low-back Pain
CRPS
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Spinal cord stimulation (SCS) delivered at 10kHz frequency (HF10 Therapy) has demonstrated superiority to traditional SCS for leg and back pain. Intermittent dosing (ID) refers to the cycling of stimu...
Detailed Description
Spinal cord stimulation (SCS) delivered at 10kHz frequency (HF10 Therapy) has demonstrated superiority to traditional SCS for leg and back pain. This mode of stimulation entails delivery of a greater ...
Eligibility Criteria
Inclusion
- Age between 18 and 90
- 1-year or more use of continuous HF10 therapy as delivered a permanently implanted Nevro Omnia Neurostimulation System for chronic back and/or leg pain
- Some level of decreasing pain relief from their SCS system (see fig. 3)
- Willing and able to complete protocol requirements, including:
- Complete health questionnaires and pain scales as specified in the protocol
- Sign the study-specific informed consent form
- Complete follow-ups at the designated time periods
Exclusion
- Previous intermittent dosing usage and/or failure
- Cervical SCS system
- Other concurrent neuromodulation system in place
- Current daily morphine milligram equivalent usage 90mg or higher
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04709757
Start Date
August 1 2021
End Date
March 1 2023
Last Update
October 5 2023
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