Trialing of ISS in Patients With CRPS
Public ClinicalTrials.gov record NCT03954080. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Trialing of Intra-spinal Stimulation in Patients With Complex Regional Pain Syndrome or Causalgia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multi-center, prospective, open-label, single-arm, observational, feasibility study. The goal of this study is to determine the feasibility of intra-spinal stimulation with optimal paresthesia coverage therapy for chronic pain relief in patients with complex regional pain syndrome type I or causalgia. Up to 20 patients with intractable chronic severe limb pain associated with complex regional pain syndrome (CRPS) will be included in the study. A standard of care trial phase to test a subjects' response to Intraspinal-Optimal Stim therapy will be conducted during a 3 to 10-day period. Patients that obtain 50% or greater pain relief during the trial period will undergo permanent implantation of the device. Primary outcome will evaluate pain response at 3 months of therapy, based on NPRS pain score relative to baseline. Patients will be followed up for 6 months after the start of therapy.
Study identification
- NCT ID
- NCT03954080
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 16 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 12, 2019
- Primary completion
- Mar 22, 2022
- Completion
- Mar 30, 2022
- Last update posted
- Apr 4, 2022
2019 – 2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Millennium Pain Center | Bloomington | Illinois | 61704 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03954080, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 4, 2022 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03954080 live on ClinicalTrials.gov.