Spinal Cord Stimulation for Complex Regional Pain Syndrome

Overseen By David B Hiller, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Scripps Health

Disqualifiers: Prior neuromodulation, Anatomical obstacles, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6 months

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating complex regional pain syndrome (CRPS) using a device called a closed-loop spinal cord stimulator. The researchers aim to evaluate the effectiveness of this treatment in the early stages of CRPS compared to later, chronic stages. Participants will be divided into two groups: those with acute or subacute CRPS and those with chronic CRPS. Individuals with CRPS in one limb who have not undergone similar nerve treatments may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research and potentially benefit from an innovative treatment approach.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this spinal cord stimulation is safe for treating complex regional pain syndrome?

Research has shown that closed-loop spinal cord stimulation (SCS) is generally safe for individuals with long-term pain. One study found that this treatment provided better pain relief and reduced the need for painkillers compared to traditional methods. Another study demonstrated that closed-loop SCS consistently relieved pain for up to 36 months, confirming its long-term safety.

Additionally, a separate study reported significant improvements in daily activities for patients using closed-loop SCS. Most patients expressed satisfaction with the pain relief they experienced from this treatment.

These findings suggest that closed-loop spinal cord stimulation is well-tolerated and safe for managing pain. However, discussing any concerns with a healthcare provider before joining a clinical trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for Complex Regional Pain Syndrome (CRPS), which often include medications like pain relievers, physical therapy, and nerve blocks, Closed Loop Spinal Cord Stimulation (SCS) offers a novel approach. This technique is unique because it continuously monitors and adjusts the electrical stimulation in response to the body's feedback, potentially providing more precise and effective pain relief. Researchers are excited about this method because it promises to tailor treatment to each individual's needs in real-time, which could lead to better outcomes and improved quality of life for those suffering from CRPS.

What evidence suggests that closed loop spinal cord stimulation is effective for complex regional pain syndrome?

Research has shown that closed-loop spinal cord stimulation (CL-SCS), which participants in this trial may receive, can significantly relieve chronic pain. In one study, patients experienced lasting pain relief and improved overall function for three years. Another study found that 80% of patients reported at least 50% less pain after one year. This treatment also reduced the need for opioid medications, commonly used for severe pain. These findings suggest that CL-SCS could effectively manage complex regional pain syndrome (CRPS), especially for those with ongoing symptoms. ^{1 2 3 6 7}

Who Is on the Research Team?

David B Hiller, MD

Principal Investigator

Physician

Are You a Good Fit for This Trial?

This trial is for individuals with Complex Regional Pain Syndrome (CRPS), a type of chronic pain condition. It's specifically looking at those in the early (acute or subacute) and chronic stages of CRPS to see if timing affects treatment response.

Inclusion Criteria

Pre-procedure psychological clearance

I have never had neuromodulation and have CRPS type 1 or 2.

Exclusion Criteria

Prior peripheral nervous system stimulation

I have had dorsal root ganglion stimulation before.

Anatomical obstacles to dorsal column lead placement

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Trial Period

Participants undergo a trial period with a temporary spinal cord stimulator for 7 days to assess improvement in pain and function

1 week

1 visit (in-person)

Treatment

Permanent spinal cord stimulator is implanted if trial period shows improvement

6 months

Follow-up visits at 3 months and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Closed Loop Spinal Cord Stimulation

Trial Overview The study is testing a Spinal Cord Stimulation Device that uses closed-loop feedback to manage pain. The goal is to compare how effective this device is when used during different phases of CRPS.

How Is the Trial Designed?

Group I: Chronic Phase of CRPS Experimental Treatment 1 Intervention

Participants diagnosed with chronic CRPS will be assigned to this group.

Group II: Acute and Subacute Phases of CRPS Experimental Treatment 1 Intervention

Participants diagnosed with acute and subacute phases of CRPS will be assigned to this group.

Closed Loop Spinal Cord Stimulation is already approved in United States for the following indications:

Approved in United States as Evoke Spinal Cord Stimulation (SCS) System for:

• Chronic intractable pain in the trunk or limbs
• Failed back surgery syndrome
• Intractable low back pain
• Leg pain

Who Is Running the Clinical Trial?

Scripps Health

Lead Sponsor

Trials

59

Recruited

43,400+

Published Research Related to This Trial

In a study of 8326 patients who underwent spinal cord stimulation (SCS) implantation, the overall incidence of spinal cord injury (SCI) was found to be low at 2.13%, indicating that SCS is a generally safe procedure.

There was no significant difference in the rates of SCI or spinal hematoma between patients receiving percutaneous (2.35%) and paddle (1.71%) electrode implantation, suggesting similar safety profiles for both methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. Petraglia, FW., Farber, SH., Gramer, R., et al.[2022]

In a 24-month study involving 50 patients, the Evoke closed-loop spinal cord stimulation (SCS) system demonstrated high efficacy, with 89.5% of patients achieving at least a 50% reduction in pain and 68.4% achieving over 80% reduction by the end of the study.

The use of the Evoke system led to significant improvements in quality of life, function, and sleep, with 82.8% of patients reducing or eliminating their opioid intake, while the need for reprogramming the device decreased to less than once a year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ECAP-Controlled Closed-Loop Spinal Cord Stimulation Efficacy and Opioid Reduction Over 24-Months: Final Results of the Prospective, Multicenter, Open-Label Avalon Study. Brooker, C., Russo, M., Cousins, MJ., et al.[2021]

The novel closed-loop spinal cord stimulation (SCS) system effectively reduced pain intensity in patients with chronic pain, showing significant decreases from a baseline score of 8.4 to 2.0 after 12 months, with 85% patient satisfaction reported.

This real-world study involving 22 patients supports the efficacy of the ECAP-controlled SCS system, maintaining pain relief comparable to results from previous clinical trials, indicating its potential as a reliable treatment option for persistent spinal pain syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Report on Real-World Outcomes with Evoked Compound Action Potential (ECAP)-Controlled Closed-Loop Spinal Cord Stimulation for Treatment of Chronic Pain. Nijhuis, HJA., Hofsté, WJ., Krabbenbos, IP., et al.[2023]

In a study of 20 CRPS patients treated with High Frequency 10 kHz spinal cord stimulation (HF10-SCS), significant reductions in pain were observed, with mean pain scores decreasing from 6.1 at baseline to 3.8 at 6 weeks post-operation.

By 6 weeks, 85% of patients reported a greater than 50% reduction in symptoms, indicating that HF10-SCS may be an effective treatment option for managing chronic pain in CRPS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of 10 kHz spinal cord stimulation in complex regional pain syndrome: A retrospective analysis. Sweeney, J., Sheldon, BL., Juneja, A., et al.[2023]

Spinal cord stimulation (SCS) significantly reduced deep pain and allodynia in patients with complex regional pain syndrome type I (CRPS I), with pain levels dropping from 10 to 0-2 on a visual analogue scale during treatment.

After an average follow-up of nearly 36 months, patients experienced improved functional status, including increased grip strength in the affected upper limb and the ability to walk without crutches in lower limb cases, alongside a reduction in pain medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation in sympathetically maintained complex regional pain syndrome type I with severe disability. A prospective clinical study. Harke, H., Gretenkort, P., Ladleif, HU., et al.[2005]

In a study of 84 patients over 11 years, spinal cord stimulation (SCS) was found to provide at least 30% pain relief for 41% of patients, indicating its effectiveness for managing complex regional pain syndrome type I.

Long-term success with SCS is more likely for patients who experience at least 50% pain relief one week after initial test stimulation, highlighting the importance of early response in predicting treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for complex regional pain syndrome type I: a prospective cohort study with long-term follow-up. Geurts, JW., Smits, H., Kemler, MA., et al.[2022]

In a study of 68 patients who had spinal cord stimulation paddle electrodes removed, the most common reason for removal was loss of coverage or effect (75%), indicating that while SCS is effective, it may not always provide lasting relief.

Postoperative complications occurred in 11.75% of patients, with two major complications requiring reoperation, highlighting that while SCS removal is generally safe, it does carry some risks that patients should be aware of.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. Maldonado-Naranjo, AL., Frizon, LA., Sabharwal, NC., et al.[2022]

In a study involving 54 patients with chronic complex regional pain syndrome type I, spinal cord stimulation (SCS) did not significantly affect pain detection thresholds for warmth, cold, or pressure over a 12-month follow-up period.

While SCS initially increased pressure detection thresholds, these effects diminished after 3 months, and the treatment only slightly reduced mechanical hyperalgesia, indicating limited long-term efficacy in altering sensory thresholds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of spinal cord stimulation on sensory characteristics in complex regional pain syndrome type I: a randomized trial. Kemler, MA., Reulen, JP., Barendse, GA., et al.[2019]

Spinal cord stimulation is presented as an effective alternative treatment for complex regional pain syndrome, a condition that is often resistant to traditional therapies.

Evidence shows that spinal cord stimulation significantly reduces pain, lowers the need for narcotics, and enhances activity levels and overall quality of life for patients suffering from this disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complex regional pain syndrome: the case for spinal cord stimulation (a brief review). Harney, D., Magner, JJ., O'Keeffe, D.[2005]

Spinal cord stimulation (SCS) was evaluated in a retrospective study of seven patients with severe complex regional pain syndrome (CRPS), showing that 72% experienced good to very good pain relief after treatment.

Despite a notable complication rate, including hardware-related issues in 28% of cases, SCS is recommended as an effective option for managing intractable pain in CRPS patients when conservative treatments fail.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for treatment of complex regional pain syndrome: a single-centre retrospective case series study. Prokopienko, M., Sobstyl, M.[2022]

In a study of 23 patients with complex regional pain syndrome, those who experienced transient pain relief from sympathetic blockade (SB) were significantly more likely to have a successful spinal cord stimulation (SCS) trial, with a success rate of 100% compared to only 30% for those with negative SB responses.

Patients who had good pain relief from SB were also more likely to achieve over 50% pain relief at both 1-month (100% vs. 33%) and 9-month (87.5% vs. 33.3%) follow-ups after permanent SCS placement, indicating that SB response can predict long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The predictive value of sympathetic block for the success of spinal cord stimulation. Hord, ED., Cohen, SP., Cosgrove, GR., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12108722/

Closed-Loop Spinal Cord Stimulation in Chronic Pain ... Closed-loop spinal cord stimulation provides superior pain relief, functional improvement, and reduced opioid dependence compared to traditional open-loop ...

2. rapm.bmj.com rapm.bmj.com/content/early/2023/08/27/rapm-2023-104751

36-month results of the EVOKE blinded randomized clinical trial ECAP-controlled CL-SCS resulted in sustained, durable pain relief and superior holistic treatment response through 36 months.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06421350

NCT06421350 | Closed Loop Spinal Cord Stimulation for ... The primary purpose of this study is to determine the differences in response to treatment of complex regional pain syndrome with a closed-loop spinal cord ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715922003725

ID:16255 Long-Term Real-World Cohort of EVOKE Closed- ... At 12 months in this real-world, post-approval experience, 80% of patients with EVOKE SCS had at least 50% pain relief and 65% of patients had at least 80% pain ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10498882/

Cost-utility Analysis of Evoke Closed-loop Spinal Cord ... The results indicate a strong economic case for the use of Evoke CL-SCS in the management of chronic back and leg pain with or without prior spinal surgery.

6. thelancet.com thelancet.com/journals/laneur/article/PIIS1474-4422(19)30414-4/abstract

Long-term safety and efficacy of closed-loop spinal cord ... Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial

7. academic.oup.com academic.oup.com/painmedicine/advance-article/doi/10.1093/pm/pnaf058/8133952

Early outcomes with a flexible ECAP based closed loop using ... A recent survey of patients receiving modern SCS waveforms found that although 83% are satisfied with overall pain reduction outcomes, over 70% proactively ...