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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

Study 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.Check my eligibility

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.See study design

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.

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I've had over 50% pain relief in a specific area in the past year.

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I am between 18 and 99 years old.

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My device was reprogrammed at least once before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

NRS pain scores

Secondary outcome measures

CPAQ-8

Charging frequency of DRG stimulator

Current mode of stimulation

+12 more

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)

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor

422 Previous Clinical Trials

163,471 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial permit participants aged 45 or older?

"Eligibility for this research project spans from 18 to 90 years old."

Answered by AI

Are there any spaces available for enrollment in this clinical trial?

"As per clinicaltrials.gov, this medical investigation is still actively seeking participants. The trial was uploaded on October 15th 2022 and recently modified on December 8th 2022."

Answered by AI

How many people have signed up to participate in this clinical research?

"Correct. The information on clinicaltrials.gov indicates that enrollment is currently open for this research project, which was first posted on October 15th 2022 and updated most recently on December 8th 2022. In total, thirty participants need to be recruited from one center."

Answered by AI

Do I qualify to participate in this scientific exploration?

"This research is enrolling 30 participants with radiculitis, aged between 18 and 90. To be eligible for the study, individuals must fulfil several criteria: within a certain age range (18-99), demonstrate at least 50% pain relief in targeted areas over the past year, have attended routine follow-up appointments in the last 4 months; had prior reprogramming of their standard device before randomization takes place; complete health questionnaires and pain scales as outlined by protocol; sign an informed consent form specific to this trial; meet designated time periods for follow ups and have been using continuous DRG therapy delivered via Abbott PROCLAIM"

Answered by AI

Recent research and studies

PainJournal

Spinal Cord Stimulation for Patients with Failed Back Surgery Syndrome or Complex Regional Pain Syndrome: A Systematic Review of Effectiveness and Complications

Turner, Judith A, John D Loeser, Richard A Deyo, and Stacy B Sanders. 2004. “Spinal Cord Stimulation for Patients with Failed Back Surgery Syndrome or Complex Regional Pain Syndrome: A Systematic Review of Effectiveness and Complications”. Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.pain.2003.12.016.

clinicaltrials.govStudy

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

Timothy Lubenow 2022. "Intermittent Dosing of Dorsal Root Ganglion Stimulation as an Alternate Paradigm to Continuous Low-Frequency Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04909138.

All > Complex Regional Pain Syndrome > Peripheral Neuropathy