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

Launched by RUSH UNIVERSITY MEDICAL CENTER · May 26, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new way to manage pain for patients who have been using a special pain relief device called a Dorsal Root Ganglion (DRG) stimulator for at least a year. The trial is focusing on patients with conditions like Complex Regional Pain Syndromes (CRPS), radiculopathy, and peripheral neuropathy. Researchers want to see if using an intermittent dosing method—where the device sends signals for 30 seconds and then pauses for 90 seconds—can be as effective as the continuous stimulation methods currently used. Participants will be divided into two groups, with one group receiving a faster frequency of stimulation and the other group a slower frequency. After a 13-week period, participants will switch to the other method to compare results.

To be eligible for this trial, participants must be between 18 and 99 years old, have used the DRG stimulator for over a year, and have experienced at least 50% pain relief in the treated area during that time. They also should have had a check-up within the last four months and be able to follow the study guidelines. Throughout the trial, participants will complete health questionnaires and pain assessments at different intervals to help the researchers understand how well the new dosing method works. Overall, this study aims to improve pain management strategies for those living with chronic pain.

Gender

ALL

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