N/A
Completed N=103
Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation
Source: ClinicalTrials.gov NCT03345472 ↗Enrolled (actual)
103
Serious AEs
1.0%
Results posted
Mar 2020
Primary outcomePrimary: Change in Overall Pain Intensity on the Visual Analog Scale (0-100) — 45.4 units on a scale
Summary
This is a prospective, single-arm, multi-center study evaluating the efficacy of spinal cord stimulation (SCS) therapy for pain relief using high dose (HD) stimulation parameters delivered to neural targets identified during current commercial trial stimulation procedures. The study will evaluate changes in back and leg pain from baseline to 3, 6, and 12 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Overall Pain Intensity on the Visual Analog Scale (0-100) |
45.4 | — |
| SECONDARY Overall Pain Efficacy Responder Rate |
68.3 | — |
| SECONDARY Low Back Pain Efficacy Responder Rate |
59.8 | — |
| SECONDARY Leg Pain Efficacy Responder Rate |
77.4 | — |
Eligibility Criteria
Inclusion Criteria
- Candidate per labeling for an SCS system as an aid in the management of chronic, intractable low back and leg pain
- Presence of low back and leg pain
- Moderate to crippled disability due to pain
- Stable pain medications for back and leg pain for at least 28 days prior to enrollment
- Willing and able to not increase pain medications through the 3-Month visit
Exclusion Criteria
- Previously trialed or implanted with stimulator or intrathecal drug delivery system
- Current diagnosis of moderate to severe central lumbar spinal stenosis
- Major psychiatric comorbidity or other progressive diseases
- Serious drug-related behavioral issues
- Pregnant or planning on becoming pregnant
- Unable to achieve supine position
Data sourced from ClinicalTrials.gov (NCT03345472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.