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

Trial Summary

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 data supports the effectiveness of the treatment Closed Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome?

Research shows that spinal cord stimulation (SCS) can help reduce pain and improve function in people with complex regional pain syndrome (CRPS). Studies have found that SCS can lower pain levels and improve the ability to perform daily activities over the long term. ^{1 2 3 4 5}

Is spinal cord stimulation safe for humans?

Spinal cord stimulation (SCS) is generally considered a safe treatment for complex regional pain syndrome and other chronic pain conditions, with long-term use showing effectiveness. However, there are some risks, such as complications from electrode removal and the potential for spinal cord injury, though these are not well-defined in the literature. ^{4 6 7 8 9}

How is Closed Loop Spinal Cord Stimulation different from other treatments for complex regional pain syndrome?

Closed Loop Spinal Cord Stimulation is unique because it uses a feedback system to measure the body's response to each electrical pulse and adjusts the stimulation in real-time to maintain consistent pain relief, unlike traditional spinal cord stimulation which does not adapt to changes in the body's response. ^{1 4 5 10 11}

What is the purpose of this trial?

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 stimulator if applied in the early phases (acute or subacute) versus the chronic phase.

Research Team

David B Hiller, MD

Principal Investigator

Physician

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 (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 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]

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 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]

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Impact of spinal cord stimulation on sensory characteristics in complex regional pain syndrome type I: a randomized trial. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation in sympathetically maintained complex regional pain syndrome type I with severe disability. A prospective clinical study. [2005]

3. United States pubmed.ncbi.nlm.nih.gov

The predictive value of sympathetic block for the success of spinal cord stimulation. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for complex regional pain syndrome type I: a prospective cohort study with long-term follow-up. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of 10 kHz spinal cord stimulation in complex regional pain syndrome: A retrospective analysis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]

7. New Zealand 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. [2023]

8. Poland pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Complex regional pain syndrome: the case for spinal cord stimulation (a brief review). [2005]

11. United States 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. [2021]