Spinal Cord Stimulation for Complex Regional Pain Syndrome
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Scripps Health
Disqualifiers: Prior neuromodulation, Anatomical obstacles, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345Is 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.
46789How 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.
1451011Eligibility 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 am 18 years old or older.
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
+2 more
Trial 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)
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Scripps Clinic Torrey PinesLa Jolla, CA
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Who Is Running the Clinical Trial?
Scripps HealthLead Sponsor
References
Impact of spinal cord stimulation on sensory characteristics in complex regional pain syndrome type I: a randomized trial. [2019]A randomized trial was performed to assess the effect of spinal cord stimulation (SCS) on detection and pain thresholds for pressure, warmth, and cold and on the extent of mechanical hyperalgesia in patients with chronic complex regional pain syndrome type I.
Spinal cord stimulation in sympathetically maintained complex regional pain syndrome type I with severe disability. A prospective clinical study. [2005]In this prospective trial we assessed the long-term effect of spinal cord stimulation (SCS) on the improvement of functional status in complex regional pain syndrome type I (CRPS I).
The predictive value of sympathetic block for the success of spinal cord stimulation. [2019]The purpose of this study was to assess the predictive value of response to sympathetic blockade (SB) on the success rate of spinal cord stimulation (SCS) in patients with complex regional pain syndrome.
Spinal cord stimulation for complex regional pain syndrome type I: a prospective cohort study with long-term follow-up. [2022]Spinal cord stimulation (SCS) is an effective treatment for intractable complex regional pain syndrome type I pain. Long-term data are scarce on effectiveness, degree of pain relief, predictors, and complications.
Efficacy of 10 kHz spinal cord stimulation in complex regional pain syndrome: A retrospective analysis. [2023]We examine the clinical efficacy of High Frequency 10 kHz (HF10) spinal cord stimulation (SCS) CRPS patients.
Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]Spinal cord stimulation (SCS) is a safe, reversible surgical treatment for complex regional pain syndrome and failed back surgery syndrome refractory to conventional medical management. Paddle electrodes are routinely used for the permanent implant because of the reduced risk of migration, lower energy requirements, and expanded coverage options. The risks associated with paddle lead removal are not well defined in the literature.
First Report on Real-World Outcomes with Evoked Compound Action Potential (ECAP)-Controlled Closed-Loop Spinal Cord Stimulation for Treatment of Chronic Pain. [2023]A novel closed-loop spinal cord stimulation (SCS) system has recently been approved for use which records evoked compound action potentials (ECAPs) from the spinal cord and utilizes these recordings to automatically adjust the stimulation strength in real time. It automatically compensates for fluctuations in distance between the epidural leads and the spinal cord by maintaining the neural response (ECAP) at a determined target level. This data collection was principally designed to evaluate the performance of this first closed-loop SCS system in a 'real-world' setting under normal conditions of use in a single European center.
Spinal cord stimulation for treatment of complex regional pain syndrome: a single-centre retrospective case series study. [2022]Complex regional pain syndrome (CRPS) is a debilitating disease with limited available treatment options. Spinal cord stimulation (SCS) is a universal option that promises to improve quality of life by reducing intractable neuropathic pain. The aim of this study was to describe the effectiveness and safety of SCS as a treatment for CRPS patients.
The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. [2022]Spinal cord stimulation (SCS) has been proven effective for multiple chronic pain syndromes. Over the past 40 years of use, the complication rates of SCS have been well defined in the literature; however, the incidence of one of the most devastating complications, spinal cord injury (SCI), remains largely unknown. The goal of the study was to quantify the incidence of SCI in both percutaneous and paddle electrode implantation.
Complex regional pain syndrome: the case for spinal cord stimulation (a brief review). [2005]Complex regional pain syndrome is a disabling disorder with an unknown mechanism which is extremely resistant to conventional pharmaceutical and therapeutic therapies. In this paper we present the underlying theories of this disorder. We present spinal cord stimulation as an alternative to conventional interventions in the management of this disabling condition spinal cord stimulation significantly improves pain, reduces narcotic intake and improves activity levels and overall quality of life. There is now a significant body of evidence to support the utilization of spinal cord stimulation in the management of complex regional pain syndrome.
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]Chronic pain is a major public health concern, as is the associated use of opioid medications, highlighting the importance of alternative treatments, such as spinal cord stimulation (SCS). Here, we present the final 24-month results of the Avalon study, which investigated the use of the first closed-loop SCS system in patients with chronic pain. The system measures the evoked compound action potentials (ECAPs) elicited by each stimulus pulse and drives a feedback loop to maintain the ECAP amplitude near constant.