32 Participants Needed

Spinal Cord Stimulation for Complex Regional Pain Syndrome

RM
JC
DB
Overseen ByDavid B Hiller, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Scripps Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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.12345

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.46789

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.1451011

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

DB

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
See 2 more

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
2Treatment groups
Experimental Treatment
Group I: Chronic Phase of CRPSExperimental Treatment1 Intervention
Participants diagnosed with chronic CRPS will be assigned to this group.
Group II: Acute and Subacute Phases of CRPSExperimental Treatment1 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

Find a Clinic Near You

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

References

Impact of spinal cord stimulation on sensory characteristics in complex regional pain syndrome type I: a randomized trial. [2019]
Spinal cord stimulation in sympathetically maintained complex regional pain syndrome type I with severe disability. A prospective clinical study. [2005]
The predictive value of sympathetic block for the success of spinal cord stimulation. [2019]
Spinal cord stimulation for complex regional pain syndrome type I: a prospective cohort study with long-term follow-up. [2022]
Efficacy of 10 kHz spinal cord stimulation in complex regional pain syndrome: A retrospective analysis. [2023]
Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]
First Report on Real-World Outcomes with Evoked Compound Action Potential (ECAP)-Controlled Closed-Loop Spinal Cord Stimulation for Treatment of Chronic Pain. [2023]
Spinal cord stimulation for treatment of complex regional pain syndrome: a single-centre retrospective case series study. [2022]
The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. [2022]
Complex regional pain syndrome: the case for spinal cord stimulation (a brief review). [2005]
11.United Statespubmed.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]
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