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NCT03794024 · ClinicalTrials.gov registry record
Comparison of Dorsal Column Stimulation to Dorsal Root Ganglion Stimulation for Complex Regional Pain Syndrome
A clinical trial, sponsored by The Cleveland Clinic.
- Terminated
- Registry status
- 1
- Enrollment target
NCT03794024: Clinical Trial study, sponsored by The Cleveland Clinic.
NCT03794024 is a clinical trial that was terminated before completion, run by The Cleveland Clinic. The registered enrollment target is 1 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03794024 was terminated before completion, sponsored by The Cleveland Clinic.
- TERMINATED
- Registry status
- 1 participants
- Enrollment target
Study Summary
Complex Regional Pain Syndrome (CRPS) is a constellation of pain symptoms which are associated with impairment in mood, social and physical function. Spinal Cord Stimulation (SCS), a technique of placing electrodes into the epidural space is a validated treatment for Complex Regional Pain Syndrome . Treatment of CRPS with SCS, in combination with physical therapy, reduced pain to a greater degree than physical therapy alone. 40%-50% of CRPS patients achieve \>50% pain relief with SCS using dorsal column stimulation . Dorsal Root Ganglion (DRG) SCS has also recently demonstrated clinical efficacy in patients with CRPS and peripheral causalgia . The hypothesis is that DRG stimulation is non-inferior to dorsal column SCS in patients with CRPS who have failed to respond to a course of analgesics and physical therapy. The aim to assess functional, quality of life, patient satisfaction and medication requirements in subjects treated with neuromodulation for CRPS and contrast outcomes amongst subjects treated with DRG SCS and dorsal column SCS.
Primary Outcome
To compare the outcomes of dorsal column stimulation with Dorsal Root Ganglion stimulation in patients with Complex Regional Pain Syndrome that persist despite a course of conservative management including physical therapy and analgesic pharmacotherapy using an 11-point \[0-10\] Numerical Rating Scale (NRS) for Pain Intensity at 6 months. A score of zero indicates no pain, and 10 indicates the worst possible pain imaginable.
Interventions
- DEVICE The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator
- DEVICE The Axium Neurostimulator System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2019-01-08 |
| Est. Completion | 2020-03-31 |
Why NCT03794024 stopped before completion
NCT03794024 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 1 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is the first listed.
NCT03794024 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03794024 about?
NCT03794024 is a clinical study titled "Comparison of Dorsal Column Stimulation to Dorsal Root Ganglion Stimulation for Complex Regional Pain Syndrome". Complex Regional Pain Syndrome (CRPS) is a constellation of pain symptoms which are associated with impairment in mood, social and physical function. Spinal Cord Stimulation (SCS), a technique of placing electrodes into the epidural space is a validated treatment for Complex Regional Pain Syndrome ....
What is the current status of trial NCT03794024?
This trial is currently terminated. The enrollment target is 1 participants. The study started on 2019-01-08. Estimated completion is 2020-03-31.
What interventions are being tested in trial NCT03794024?
The interventions under investigation include: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator (DEVICE), The Axium Neurostimulator System (DEVICE).
Who is sponsoring clinical trial NCT03794024?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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