Phase 4
Completed N=30
Spinal Cord Stimulation (SCS) Dosing Study
Back Pain · Leg Pain
Source: ClinicalTrials.gov NCT03284411 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: SCS Therapy Satisfaction — 6; 2; 1; 0 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study characterized the effects of amplitude on subject satisfaction and pain relief in subjects being treated by SCS.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SCS Therapy Satisfaction |
6; 2; 1; 0; 21 | — |
| SECONDARY Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS) |
5; 3; 1; 2; 19 | — |
Eligibility Criteria
Inclusion Criteria
- 22 years of age or older
- Implanted with a RestoreSensor system (for back and leg pain) for at least 1 month
- Has approproate SCS settings
- Willing and able to provide signed and dated informed consent
- Capable of comprehending and consenting in English
- Capable of getting into the supine and sitting positions
- Willing and able to comply with all study procedures and visits
- On stable (no change in dose, route, or frequency) prescribed pain medications
Exclusion Criteria
- Implanted with leads for peripheral nerve stimulation or an implantable intrathecal drug delivery system
- Had a pain-related surgery in the previous 1 month of enrollment or the intent to undergo surgery during the period of the study
- Implanted with quadripolar lead
- Currently enrolled or planning to enroll in a potentially confounding clinical study during the course of the study
- Pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
- Has untreated major psychiatric comorbidity
- Has serious drug-related behavioral issues
- Has unresolved major issues of secondary gain
Data sourced from ClinicalTrials.gov (NCT03284411). 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.