Status:
RECRUITING
Intermittent Dosing of Dorsal Root Ganglion Stimulation as an Alternate Paradigm to Continuous Low-Frequency Therapy
Lead Sponsor:
Rush University Medical Center
Conditions:
CRPS (Complex Regional Pain Syndromes)
Radiculopathy
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
This study seeks to evaluate the use of intermittent dosing as an alternative paradigm for patients with DRG stimulation in place for at least 1 year and minimum 50% pain relief in the targeted area. ...
Detailed Description
Dorsal Root Ganglion (DRG) is a novel target of neuromodulation that's use has grown as a proven effective treatment in chronic painful conditions. Studies examining tonic, paresthesia-based dorsal co...
Eligibility Criteria
Inclusion
- Age between 18 and 99
- 1-year or more use of continuous DRG therapy as delivered a permanently implanted Abbott PROCLAIM XR Dorsal Root Ganglion Neurostimulator System for chronic back and/or leg pain
- Endorse at least 50% pain relief in the targeted area over the last year
- Must have been seen for routine follow-up within last 4 months
- Must have been reprogrammed in standard fashion at least once prior to randomization
- 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
- Significant lead migration, as determined by clinician
- Other concurrent neuromodulation system in place
- Corticosteroid injection in previous 30 days prior to enrollment
- Intermittent dosing and/or failure within last 6m
- Changing or unstable pain medications within 30 days
Key Trial Info
Start Date :
October 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04909138
Start Date
October 15 2022
End Date
December 1 2026
Last Update
December 9 2025
Active Locations (1)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612