DRG Stimulation for Complex Regional Pain Syndrome

Overseen By Daniel Torrez, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Must not be taking: Corticosteroids

Disqualifiers: Lead migration, Other neuromodulation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore new methods of using Dorsal Root Ganglion (DRG) stimulation for individuals with Complex Regional Pain Syndrome, a condition causing chronic pain in the back or legs. Participants will test two different stimulation patterns to determine which provides better pain relief. The trial is designed for those who have undergone DRG therapy for over a year and have experienced at least 50% pain relief. Participants should be comfortable with regular check-ins and completing health surveys. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you should not have changing or unstable pain medications within 30 days before joining. It's best to discuss your specific medications with the trial team.

What prior data suggests that this DRG stimulation technique is safe for patients with Complex Regional Pain Syndrome?

Research has shown that stimulating the dorsal root ganglion (DRG) safely treats chronic pain. Studies have found it well-tolerated and effective, with many patients experiencing significant pain relief. In one study with 62 patients, DRG stimulation was used for long-term nerve pain treatment and showed promising safety results.

Other research supports these findings, indicating that DRG stimulation is a safe option for treating various types of chronic pain, including complex regional pain syndrome, which is a focus of this study. The studies did not report major side effects, suggesting that this treatment is generally well-tolerated.

Overall, evidence supports the safety of DRG stimulation, whether using the 20 Hz or 5 Hz settings. Similar studies have successfully used the treatment, demonstrating a strong safety profile for those considering participation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about DRG stimulation for Complex Regional Pain Syndrome because it offers a unique mechanism of action compared to standard treatments like medication and physical therapy. Unlike these traditional methods, which often focus on managing symptoms, DRG stimulation directly targets the dorsal root ganglion, a cluster of nerves that plays a key role in pain transmission. This targeted approach may provide more precise pain relief with potentially fewer side effects. The trial examines two different frequencies, 20 Hz and 5 Hz, to determine the most effective stimulation pattern, promising new insights into personalized pain management.

What evidence suggests that this trial's treatments could be effective for Complex Regional Pain Syndrome?

Research has shown that stimulating the dorsal root ganglion (DRG) effectively manages chronic pain, including complex regional pain syndrome (CRPS). A review of studies found that DRG stimulation can improve quality of life and reduce pain. One study showed that up to 80% of patients experienced significant pain relief in certain areas. In this trial, participants will receive DRG stimulation therapy at different frequencies, specifically 20 Hz or 5 Hz, to evaluate if these settings offer even better pain relief. Overall, DRG stimulation is a promising option for people who haven't found relief with other treatments. ^{2 5 6 7 8}

Who Is on the Research Team?

Robert McCarthy, PharmD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I have used the Abbott PROCLAIM XR system for over a year for my chronic back or leg pain.

Must have been seen for routine follow-up within last 4 months

Exclusion Criteria

Other concurrent neuromodulation system in place

Significant lead migration as determined by clinician

I have missed doses or my treatment failed in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Randomization and Initial Evaluation

Participants are randomized into one of two stimulation paradigms and evaluated prior to reprogramming

1 week

1 visit (in-person)

Treatment Phase 1

Participants receive DRG stimulation therapy with intermittent dosing, evaluated at 4, 8, and 12 weeks

12 weeks

3 visits (in-person)

Washout and Crossover

Participants undergo a 1-week washout period followed by crossover to the alternate study arm

1 week

1 visit (in-person)

Treatment Phase 2

Participants receive the alternate DRG stimulation therapy, evaluated at 17, 21, and 25 weeks

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DRG stimulation 20 Hz 30/90
• DRG stimulation 5 Hz 30/90

Trial Overview 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.

How Is the Trial Designed?

Group I: DRG stimulation therapy at 20 Hz and 30 seconds ON, 90 seconds OFF Active Control 1 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 OFF Active Control 1 Intervention

DRG stimulation therapy at 5 Hz (30 seconds ON, 90 seconds OFF)

DRG stimulation 20 Hz 30/90 is already approved in European Union, United States for the following indications:

Approved in European Union as Dorsal Root Ganglion Stimulation for:

• Chronic pain
• Neuropathic pain
• Complex Regional Pain Syndrome (CRPS)
• Radiculopathy

Approved in United States as Dorsal Root Ganglion Stimulation for:

• Chronic pain
• Neuropathic pain
• Complex Regional Pain Syndrome (CRPS)
• Radiculopathy

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Published Research Related to This Trial

In a study of 20 patients with complex regional pain syndrome (CRPS) of the upper extremities, 85% achieved at least 50% pain relief after dorsal root ganglion (DRG) neuromodulation, with sustained relief reported at six months.

While DRG neuromodulation significantly reduced pain and opioid use, it was associated with a 30% complication rate, including one serious case of reversible spinal cord compression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Cervical and High-Thoracic Dorsal Root Ganglion Stimulation Therapy for Complex Regional Pain Syndrome of the Upper Extremities. Graca, MJ., Lubenow, TR., Landphair, WR., et al.[2023]

In a study of 66 participants with chronic pain, dorsal root ganglion (DRG) stimulation led to a significant reduction in pain levels, with average pain ratings dropping from 8.0 cm to 4.1 cm after 12 months, and 49% of subjects experiencing at least a 50% reduction in pain.

The treatment also improved functional capacity, mood, and quality of life, with a high success rate of permanent implants (86.2%) and a low incidence of complications such as infections or lead migrations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Dorsal Root Ganglion Stimulation in a Prospective Dutch Cohort. Huygen, FJPM., Liem, L., Nijhuis, H., et al.[2022]

Dorsal root ganglion (DRG) stimulation has shown effectiveness in treating chronic neuropathic postsurgical pain (NPP) specifically in areas like the groin, knee, and foot, based on a review of existing literature.

Conditions such as pain following thoracotomy, hernia surgery, and knee replacement surgery are identified as likely benefiting from DRG stimulation, although more prospective studies are needed to validate these findings against the growing clinical experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation of the Dorsal Root Ganglion for Chronic Postsurgical Pain. Antony, AB., Schultheis, BC., Jolly, SM., et al.[2020]

A systematic review of 28 studies involving 354 patients indicates that dorsal root ganglion stimulation (DRGS) can lead to over 50% pain reduction in various non-CRPS chronic pain syndromes, such as axial low back pain and chronic pelvic pain.

Patients receiving DRGS also reported significant improvements in physical function, quality of life, and reduced reliance on pain medications, although the evidence is primarily from lower-level studies, highlighting the need for more rigorous research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dorsal Root Ganglion Stimulation for the Treatment of Non-Complex Regional Pain Syndrome Related Chronic Pain Syndromes: A Systematic Review. Stelter, B., Karri, J., Marathe, A., et al.[2022]

Dorsal root ganglion stimulation (DRGS) has shown promising results in treating neuropathic pain, particularly in conditions like complex regional pain syndrome (CRPS) and causalgia, with Class A randomized clinical trial evidence indicating it provides superior pain relief compared to spinal cord stimulation (SCS).

While DRGS has been effective for various pain types, including postsurgical pain and phantom pain, its success in treating failed back surgery syndrome (FBSS) is less clear, and long-term outcomes are still needed to fully understand its efficacy across different pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy and Safety of Dorsal Root Ganglion Stimulation as a Treatment for Neuropathic Pain: A Literature Review. Harrison, C., Epton, S., Bojanic, S., et al.[2022]

Dorsal root ganglion stimulation (DRGS) shows a low infection risk during the trial stage (1.03%), but the risk significantly increases during the implant stage (4.80%), indicating a need for careful monitoring and prophylaxis during this procedure.

This systematic review analyzed data from 10 studies involving 567 patients, providing the first comprehensive look at infection rates associated with DRGS at different stages, highlighting the importance of further research into infection management in this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infectious Complications of Dorsal Root Ganglion Stimulation: A Systematic Review and Pooled Analysis of Incidence. Moman, RN., Peterson, AA., Maher, DP., et al.[2022]

In a study of 93 patients receiving dorsal root ganglion (DRG) stimulation for pain relief, those with a history of chronic opioid use were less likely to achieve significant pain relief (≥50% or ≥80%) at multiple follow-up points (1 month, 3 months, and 12 months).

The findings suggest that prior chronic opioid use may negatively impact the effectiveness of DRG stimulation, indicating that patient history should be considered when predicting treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Patient Characteristics on Clinical Outcomes More Than 12 Months Following Dorsal Root Ganglion Stimulation Implantation: A Retrospective Review. Hagedorn, JM., McArdle, I., D'Souza, RS., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5359787/

Dorsal root ganglion stimulation yielded higher treatment ... A comparative effectiveness trial indicates that dorsal root ganglion stimulation provided a higher rate of treatment success with less postural variation ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1878875024010982

Effectiveness of Dorsal Root Ganglion Stimulation in ... This systematic review affirms the effectiveness of DRGS therapy in managing diverse chronic pain conditions, highlighting improvements in quality of life, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7079258/

Effectiveness and Safety of Dorsal Root Ganglion ... Our pooled analysis showed a pain score for primary affected region ranging from 1.7 (groin) to 3.0 (buttocks) and responder rates of 80% for foot and groin, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04909138

Intermittent Dosing of Dorsal Root Ganglion Stimulation as ... As our primary endpoint, we hypothesize that intermittent dosing with either 20 Hz frequency (high) or 5 Hz frequency (low) ID will provide superior pain relief ...

5. mainlinespine.com mainlinespine.com/news/health-letter/dorsal-root-ganglion-stimulation-and-crps/

DRG Stimulation for Chronic Regional Pain Syndrome DRG stimulation has shown to be effective for CRPS when SCS isn't a viable option. It works by targeting neurostimulation at the dorsal root ganglion. What Is a ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7065079/

Safety Analysis of Dorsal Root Ganglion Stimulation in the ... Dorsal root ganglion stimulation (DRGS) for the treatment of chronic neuropathic pain: a single‐center study with long‐term prospective results in 62 cases.

7. sciencedirect.com sciencedirect.com/science/article/pii/S109471592100012X

Three-Year Outcomes After Dorsal Root Ganglion ... DRG neuromodulation appears to be a safe, effective, and durable option for treating neuropathic pain caused by PNI.

8. journals.lww.com journals.lww.com/pain/fulltext/2017/04000/dorsal_root_ganglion_stimulation_yielded_higher.14.aspx

Dorsal root ganglion stimulation yielded higher treatment... The results show that DRG stimulation provided a higher rate of treatment success with less postural variation in paresthesia intensity compared to SCS.