N/A
Completed N=73
VELOCITY: A Study to Characterize Real-World Outcomes of Spinal Cord Stimulation
Source: ClinicalTrials.gov NCT02741297 ↗Enrolled (actual)
73
Serious AEs
8.2%
Results posted
Jan 2020
Primary outcomePrimary: Percentage of Low Back Pain Responders — 25; 23 Participants
Summary
The primary objective of this study is to characterize the real-world outcomes of spinal cord stimulation (SCS) therapy as an aid in the management of chronic intractable pain of the trunk, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain using the Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System with MultiWave Technology.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Low Back Pain Responders |
25; 23 | — |
Eligibility Criteria
Key Inclusion Criteria
- Complaint of persistent or recurrent low back pain for at least 180 days prior to Screening
- Willing and able to comply with all protocol-required procedures and assessments/evaluations
- Subject signed a valid, ethics committee (EC)-approved informed consent form (ICF) provided in local language
Key Exclusion Criteria
- High surgical risk
- Previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
- A female who is pregnant, is breastfeeding, or is of childbearing potential and planning to get pregnant during the course of the study or not using adequate contraception.
- Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study
- Any diagnosis or condition that, in the clinician's best judgment, might confound reporting of study outcomes
Data sourced from ClinicalTrials.gov (NCT02741297). 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.