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Behavioural Intervention

DRG Stimulation for Complex Regional Pain Syndrome

N/A
Recruiting
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trialevaluates a new type of dosing for pain relief in patients with DRG stimulation.

Who is the study for?
This trial is for adults aged 18-99 with chronic back or leg pain who've had significant pain relief from a DRG stimulator for at least a year. They should have followed up recently, been reprogrammed before, and be willing to follow the study plan and complete health surveys.
What is being tested?
The study tests two intermittent dosing patterns of DRG stimulation as alternatives to continuous therapy. Participants will try both methods: one with higher frequency (20 Hz) and another with lower (5 Hz), switching after 13 weeks, to see which works better for pain management.
What are the potential side effects?
While specific side effects are not listed here, DRG stimulation can generally cause discomfort at the implant site, tingling sensations in the treatment area, infection risk from surgery, and potential changes in pain levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have used the Abbott PROCLAIM XR system for over a year for my chronic back or leg pain.
Select...
I've had over 50% pain relief in a specific area in the past year.
Select...
I am between 18 and 99 years old.
Select...
My device was reprogrammed at least once before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
NRS pain scores
Secondary study objectives
CPAQ-8
Charging frequency of DRG stimulator
Current mode of stimulation
+12 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: DRG stimulation therapy at 20 Hz and 30 seconds ON, 90 seconds OFFActive Control1 Intervention
DRG stimulation therapy at 20 Hz (30 seconds ON, 90 seconds OFF)
Group II: DRG stimulation therapy at 5 Hz and 30 seconds ON, 90 seconds OFFActive Control1 Intervention
DRG stimulation therapy at 5 Hz (30 seconds ON, 90 seconds OFF)

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor
435 Previous Clinical Trials
249,264 Total Patients Enrolled
2 Trials studying Radiculopathy
Robert McCarthy, PharmDStudy DirectorRush University Medical Center
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

DRG stimulation 20 Hz 30/90 (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04909138 — N/A
DRG stimulation 20 Hz 30/90 (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04909138 — N/A
Radiculopathy Research Study Groups: DRG stimulation therapy at 20 Hz and 30 seconds ON, 90 seconds OFF, DRG stimulation therapy at 5 Hz and 30 seconds ON, 90 seconds OFF
Radiculopathy Clinical Trial 2023: DRG stimulation 20 Hz 30/90 Highlights & Side Effects. Trial Name: NCT04909138 — N/A
~6 spots leftby Jun 2025
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