Intermittent Dosing of Dorsal Root Ganglion Stimulation as an Alternate Paradigm to Continuous Low-Frequency Therapy
RecruitingNot applicableNCT04909138
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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. Patients will be prospectively randomized to one of two stimulation paradigms both of which involve intermittent dosing at 30 seconds ON and 90 seconds OFF. Group 1 will have their frequency set at 20 Hz with amplitude levels adjusted in order to remain in the therapeutic window (subthreshold stimulation). Group 2 will have their frequency set at 5 Hz with amplitude levels adjusted in order to remain in the therapeutic window (subthreshold stimulation) This study will be performed in a crossover fashion, meaning patients will be changed to the alternate dosing regimen at the 13-week time period. Patients will be seen and evaluated prior to randomization and reprogramming, and thereafter evaluated at 4, 8, and 12-weeks. At the 12-week time period, patients will begin a 1-week washout period of continuous stimulation. At the 13-week time period, patients will be evaluated, crossed over to the other study arm and thereafter evaluated at 17, 21, and 25-weeks.
Study details
- Official title
- Intermittent Dosing of Dorsal Root Ganglion Stimulation as an Alternate Paradigm to Continuous Low-Frequency Therapy
- Conditions
- CRPS (Complex Regional Pain Syndromes)
- Radiculopathy
- Peripheral Neuropathy
- Interventions
- Device: DRG stimulation 20 Hz 30/90
- Device: DRG stimulation 5 Hz 30/90
- Sponsor
- Rush University Medical Center
- Start date
- 2022-10-15
- Primary completion
- 2026-06
- Sex
- All
- Age range
- from 18 Years to 90 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04909138