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NCT05283863 · ClinicalTrials.gov registry record · NA
Direct Comparison of Spinal Cord Stimulator Parameter Settings
A NA study, sponsored by Case Western Reserve University.
- Completed
- Registry status
- NA
- Development phase
- 4
- Enrollment target
NCT05283863: Completed NA study, sponsored by Case Western Reserve University.
NCT05283863 is a NA study that has completed, run by Case Western Reserve University. The registered enrollment target is 4 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05283863, a NA study, has completed, sponsored by Case Western Reserve University.
- COMPLETED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
Study Summary
(Primary) 1. To compare the clinical effects and side effects of two different stimulation strategies that do not produce any sensory percept (1000 Hz and placebo) on clinical benefit for electrodes implanted for chronic pain as measured by the Visual Analog Pain Scale for back and leg pain, the Brief Pain Inventory, the 36-Item Short Form Survey (SF-36), and the Pain Vigilance and Awareness Questionnaire. (Secondary) 2. To compare the clinical effects of the subthreshold (paresthesia-free) stimulation patterns with conventional (paresthesia-producing) stimulation patterns to evaluate the necessity of paresthesias and current amplitudes on clinical benefit for pain. 3. To identify the ability of subthreshold high-frequency to improve axial pain or the affective component of pain.
Primary Outcome
Assessment of overall degree of back and leg pain during each phase of stimulation (ie conventional baseline stimulation, high-density stimulation, conventional "washout" stimulation, and sham stimulation). Scores range from 0 - 100, with a higher score indicating more pain.
Interventions
- DEVICE Sham Stimulation
- DEVICE High-frequency stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2015-06 |
| Est. Completion | 2015-08 |
| Phase | NA |
What the finished NCT05283863 record still lists
NCT05283863 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham Stimulation is the first listed.
NCT05283863 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05283863 about?
NCT05283863 is a clinical study titled "Direct Comparison of Spinal Cord Stimulator Parameter Settings". (Primary) 1. To compare the clinical effects and side effects of two different stimulation strategies that do not produce any sensory percept (1000 Hz and placebo) on clinical benefit for electrodes implanted for chronic pain as measured by the Visual Analog Pain Scale for back and leg pain, the Br...
What is the current status of trial NCT05283863?
This trial is currently completed. It is a NA study. The enrollment target is 4 participants. The study started on 2015-06. Estimated completion is 2015-08.
What interventions are being tested in trial NCT05283863?
The interventions under investigation include: Sham Stimulation (DEVICE), High-frequency stimulation (DEVICE).
Who is sponsoring clinical trial NCT05283863?
This trial is sponsored by Case Western Reserve University, which has 141 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05283863's enrollment target sits among peer trials
4 1996th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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