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Clinical Trials/NL-OMON42937
NL-OMON42937
Completed
Not Applicable

A Multi-Center Controlled Study to characterize the real-world outcomes of High Rate Spinal Cord Stimulation therapy using Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System - VELOCITY

Boston Scientific Group plc.0 sites6 target enrollmentTBD
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Conditionscontinued back pain after surgeryDifficult to treat low back pain1004154310009720

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
continued back pain after surgery
Sponsor
Boston Scientific Group plc.
Enrollment
6
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
April 26, 2019
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\-Complaint of persistent or recurrent low back pain for at least 180 days prior to Screening
  • •\-No back surgery within 6 months prior to Screening
  • •\-Average low back pain intensity of 6 or greater on a 0\-10 numerical rating scale during Screening (NRS) as evaluated by interview
  • •\-Baseline Oswestry Disability Index score \>40 and \<81
  • •\-18 years of age or older when written informed consent is obtained

Exclusion Criteria

  • •\-Average leg pain is greater than or equal to average low back pain during Screening (NRS).
  • •\-Radiographic evidence of spinal instability requiring fusion
  • •\-Require implantation of lead(s) in the cervical epidural space
  • •\-Requires implantation of paddle\-style SCS lead(s) via a laminotomy and/or laminectomy
  • •\-Previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)

Outcomes

Primary Outcomes

Not specified

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