SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery (NCT04676022) | Clinical Trial Compass
CompletedNot Applicable
SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery
United States241 participantsStarted 2021-03-26
Plain-language 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.
Who can participate
Age range22 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)