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

CompletedNot applicableNCT04676022
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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 details

Official title
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
Conditions
Interventions
  • Device: WaveWriter
  • Other: Conventional Medical Managament
Sponsor
Boston Scientific Corporation
Start date
2021-03-26
Primary completion
2022-08-25
Sex
All
Age range
from 22 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
23

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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)

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04676022