N/A
N=241
SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT04676022 ↗Enrolled (actual)
241
Serious AEs
6.1%
Results posted
May 2024
Primary outcome: Primary: Responder Rate — 51; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- WaveWriter (Device); Conventional Medical Managament (Other)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder Rate |
51; 5 | — |
| SECONDARY Change in Disability (Oswestry Disability Index) |
-27.5; -7.2 | — |
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.
Eligibility Criteria
Key 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
Key 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)
Data sourced from ClinicalTrials.gov (NCT04676022). 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.