Intermittent Dosing of Dorsal Root Ganglion Stimulation as an Alternate Paradigm to Continuous Low-Frequency Therapy
- NCT ID
- NCT04909138
- Registry status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Rush University Medical Center
- Conditions
- CRPS (Complex Regional Pain Syndromes), Peripheral Neuropathy, Radiculopathy
Overview
ClinicalTrials.gov lists this study as Recruiting.
Enrollment: 30 participants (Estimated).
What is being studied
- Device: DRG stimulation 20 Hz 30/90
- Device: DRG stimulation 5 Hz 30/90
Who may be eligible
- Ages
- 18 Years to 90 Years
- Sex
- All
- Healthy volunteers accepted
- No
ClinicalTrials.gov lists the following eligibility criteria.
Inclusion Criteria:
* 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 Criteria:
* 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
Study locations
1 study location is listed.
Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.
Countries: United States
- Illinois, United States: 1
Sample of listed locations
- Rush University Medical Center — Chicago, Illinois, 60612, United States — Recruiting
Study details
- Start date
- October 15, 2022
- Primary completion date
- June 1, 2026
- Completion date
- June 1, 2027
- First posted
- June 1, 2021
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT04909138
- Registry last updated
- January 21, 2026
- QualifiedStudies registry data refreshed
- October 2, 2026
- QualifiedStudies record fetched
- October 2, 2026
View NCT04909138 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
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