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Spinal Cord Stimulation

Spinal Cord Stimulation for Complex Regional Pain Syndrome

N/A
Recruiting
Led By David B Hiller, MD
Research Sponsored by Scripps Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years or older
Neuromodulation naive patients with unilateral CRPS type 1 or type 2 (defined by Budapest Criteria)
Must not have
Younger than 18 years
Prior neuromodulation including spinal cord stimulation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 day trial period, 3 months and 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if using a closed-loop spinal cord stimulator early on in complex regional pain syndrome treatment is more effective than using it in the later stages.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed, spinal cord stimulation can sometimes cause discomfort at the implant site, unwanted changes in stimulation, and infection risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have never had neuromodulation and have CRPS type 1 or 2.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
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I have had treatments like spinal cord stimulation before.
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I have had dorsal root ganglion stimulation before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 day trial period, 3 months and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 day trial period, 3 months and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Complex Regional Pain Syndrome Severity Scores
Change in Target Activation Amplitude Levels by the Spinal Cord Stimulation Device
Secondary study objectives
Amount of Pain Medication Consumed by Patient
Change in Prolactin Levels
General Anxiety Disorder-7
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Find a Location

Who is running the clinical trial?

Scripps HealthLead Sponsor
58 Previous Clinical Trials
43,541 Total Patients Enrolled
David B Hiller, MDPrincipal InvestigatorPhysician
~21 spots leftby Jun 2026
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