RecruitingNot ApplicableNCT04909138

Intermittent Dosing of Dorsal Root Ganglion Stimulation as an Alternate Paradigm to Continuous Low-Frequency Therapy


Sponsor

Rush University Medical Center

Enrollment

30 participants

Start Date

Oct 15, 2022

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether using dorsal root ganglion (DRG) stimulation in an intermittent (on/off) pattern — rather than continuous low-frequency stimulation — provides better or equivalent pain relief for people with chronic back and/or leg pain. DRG stimulation is a type of implanted nerve stimulator. You may be eligible if: - You are 18–99 years old - You have had a permanent Abbott PROCLAIM XR DRG neurostimulator implanted for at least 1 year for chronic back and/or leg pain - You have had at least 50% pain relief in the target area over the past year - You have had a routine follow-up within the past 4 months and have been reprogrammed at least once You may NOT be eligible if: - You have significant lead migration from your device - You have another neuromodulation device - You have had a corticosteroid injection in the past 30 days - You have had intermittent dosing tried and failed in the past 6 months - You have recently changed pain medications (within 30 days) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDRG stimulation 20 Hz 30/90

Stimulation delivered at 20 Hz and 30 seconds ON, 90 seconds OFF

DEVICEDRG stimulation 5 Hz 30/90

Stimulation delivered at 5 Hz and 30 seconds ON, 90 seconds OFF


Locations(1)

Rush University Medical Center

Chicago, Illinois, United States

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NCT04909138


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