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NCT01697358 · ClinicalTrials.gov registry record · Phase 4
Spinal Cord Stimulation for Predominant Low Back Pain
A Phase 4 study, sponsored by MedtronicNeuro.
- Completed
- Registry status
- Phase 4
- Development phase
- 278
- Enrollment target
NCT01697358: Completed Phase 4 study, sponsored by MedtronicNeuro.
NCT01697358 is a Phase 4 study that has completed, run by MedtronicNeuro. The registered enrollment target is 278 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01697358, a Phase 4 study, has completed, sponsored by MedtronicNeuro.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 278 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering from predominant low back pain due to failed back surgery syndrome (FBSS).
Primary Outcome
Compare the proportion of subjects with a ≥50% reduction in low back pain intensity, as measured by the NPRS, from baseline to the end of Period I in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Percent reduction in low back pain intensity was calculated as average NPRS at (6-month visit - baseli
Interventions
- DEVICE Spinal Cord Stimulation (SCS)
- DRUG Optimal Medical Management (OMM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 278 participants |
| Start Date | 2013-01-08 |
| Est. Completion | 2017-06-20 |
| Phase | Phase 4 |
What the finished NCT01697358 record still lists
NCT01697358 is an interventional study that assigns participants to a tested intervention. The registered 278 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 2 interventions - of which Spinal Cord Stimulation (SCS) is the first listed.
NCT01697358 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01697358 about?
NCT01697358 is a clinical study titled "Spinal Cord Stimulation for Predominant Low Back Pain". The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering from predominant low back pain due to failed back surgery syndrome (FBS...
What is the current status of trial NCT01697358?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 278 participants. The study started on 2013-01-08. Estimated completion is 2017-06-20.
What interventions are being tested in trial NCT01697358?
The interventions under investigation include: Spinal Cord Stimulation (SCS) (DEVICE), Optimal Medical Management (OMM) (DRUG).
Who is sponsoring clinical trial NCT01697358?
This trial is sponsored by MedtronicNeuro, which has 51 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01697358's enrollment target sits among peer trials
278 307th of 2000 higher than 1,691 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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