N/A
N=35
Study to Characterize Effects of Programming in SCS Patients Undergoing a Temporary Trial
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT02988713 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Patient Comfort — 30 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Programming (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Comfort |
30 | — |
Summary
This is a prospective, multi-center, non-randomized, exploratory, single-arm study characterize the effects of programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
Eligibility Criteria
Key Inclusion Criteria
- Study candidate is undergoing a spinal cord stimulation (SCS) trial of BSC neurostimulation system, per local directions for use (DFU).
- Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form.
- Subject is 18 years of age or older when written informed consent is obtained.
Key Exclusion Criteria
- Subject meets any contraindication in BSC neurostimulation system local directions for use (DFU).
Data sourced from ClinicalTrials.gov (NCT02988713). 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.