SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery (SOLIS)

Boston Scientific

Status

Active, not recruiting

Conditions

Chronic Pain

Treatments

Other: Conventional Medical Managament

Device: WaveWriter

Study type

Interventional

Funder types

Industry

Identifiers

NCT04676022

A4077

Details and patient eligibility

About

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.

Enrollment

241 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)