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Clinical Trials/NCT04676022
NCT04676022CompletedNot Applicable

A Randomized Controlled Study to Evaluate the Safety and Effectiveness of Boston Scientific Spinal Cord Stimulation (SCS) Systems in the Treatment of Chronic Low Back and/or Leg Pain With No Prior Surgeries

Boston Scientific Corporation23 sites in 1 country241 target enrollmentStarted: March 26, 2021Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
241
Locations
23
Primary Endpoint
Responder Rate
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To evaluate the safety and effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities compared to Conventional Medical Management (CMM) in patients with chronic low back and/or leg pain who have not undergone spinal surgery when using the Boston Scientific WaveWriter SCS Systems.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
22 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Chronic low back pain, with or without leg pain, for at least 6 months
  • •Received at least 90 days of documented pain management care to address the primary pain complaint, prior to Screening (e.g. medication, physical therapy)
  • •If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test at Screening
  • •Subject signed a valid, IRB-approved informed consent form (ICF) provided in English

Exclusion Criteria

  • •Primary pain complaint of vascular origin (e.g. peripheral vascular disease)
  • •Require implantation of lead(s) in the cervical epidural space
  • •Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to assess pain intensity
  • •Previous failed spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)

Arms & Interventions

Spinal Cord Stimulation

Experimental

To receive Spinal Cord Stimulation programming

Intervention: WaveWriter (Device)

Conventional Medical Management

Other

To receive conventional medical management

Intervention: Conventional Medical Managament (Other)

Outcomes

Primary Outcomes

Responder Rate

Time Frame: 3 months post-activation

Proportion of subjects with 50% or greater reduction in overall pain relief

Secondary Outcomes

  • Change in Disability (Oswestry Disability Index)(3-Months post activation)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (23)

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