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

NCT04676022 | Completed Results FDA Device

• 1 other identifier: A4077
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 23

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.

Conditions

Chronic Pain

Keywords

Spinal Cord Stimulation

Outcome Measures

Primary Outcomes (1)

• Responder Rate

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

  3 months post-activation

Secondary Outcomes (1)

• Change in Disability (Oswestry Disability Index)

  3-Months post activation

Study Arms (2)

Spinal Cord Stimulation

EXPERIMENTAL

To receive Spinal Cord Stimulation programming

Device: WaveWriter

Conventional Medical Management

OTHER

To receive conventional medical management

Other: Conventional Medical Managament

Interventions

WaveWriter DEVICE

To receive Spinal Cord Stimulation programming

Spinal Cord Stimulation

Conventional Medical Managament OTHER

To receive conventional medical management

Conventional Medical Management

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (23)

Vitamed Research

Palm Desert, California, 92260, United States

Location

Summit Pain Alliance

Santa Rosa, California, 95401, United States

Location

Denver Back Pain Specialists

Greenwood Village, Colorado, 80111, United States

Location

South Lake Pain Institute, Inc

Clermont, Florida, 34711, United States

Location

University of Chicago Hospital

Chicago, Illinois, 60637, United States

Location

Goodman Campbell Brain and Spine

Carmel, Indiana, 46032, United States

Location

Crimson Pain Management

Overland Park, Kansas, 66210, United States

Location

MedPharmics, LLC

Metairie, Louisiana, 70006, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70115, United States

Location

Willis-Knighton River Cities Clinical Research Center

Shreveport, Louisiana, 71105, United States

Location

Forest Health Medical Center

Ypsilanti, Michigan, 48198, United States

Location

Saint Louis Pain Consultants

Chesterfield, Missouri, 63017, United States

Location

Weill Cornell Medical University

New York, New York, 10022, United States

Location

Carolinas Research Institute, PLLC

Huntersville, North Carolina, 28078, United States

Location

Novant Health-Hawthorne

Winston-Salem, North Carolina, 27103, United States

Location

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

The Toledo Clinic

Toledo, Ohio, 43623, United States

Location

Pacific Sports and Spine, LLC

Eugene, Oregon, 97401, United States

Location

Delaware Valley Pain and Spine Institute

Trevose, Pennsylvania, 19053, United States

Location

PCPMG Clinical Research Unit, LLC

Greenville, South Carolina, 29601, United States

Location

Institute of Precision Pain Medicine

Corpus Christi, Texas, 78414, United States

Location

Precision Spine Care

Tyler, Texas, 75701, United States

Location

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84132, United States

Location

Related Publications (2)

• North J, Calodney A, Trainor D, McCormick ZL, Paez J, Loudermilk E, Christopher A, Noles J, Phillips G, Jolly S, Yang MI, Guirguis M, Kloster D, Pak DJ, Peacock J, Engle M, Shah B, Wilson D, Anitescu M, Atallah J, Chatas J, Leier T, Rosen S, Goldberg E. Spinal cord stimulation plus conventional medical management versus conventional medical management alone for severe, non-surgical, refractory back pain: a randomized clinical trial followed by crossover. Reg Anesth Pain Med. 2025 Oct 5:rapm-2024-106335. doi: 10.1136/rapm-2024-106335. Online ahead of print.

  PMID: 41047246 DERIVED

• O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.

  PMID: 34854473 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sr. Director, Clinical Operations
• Organization: Boston Scientific Corporation

BSNClinicalTrials@bsci.com

855-213-9890

Study Officials

• Natalie Bloom Lyons

  Boston Scientific Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 19, 2020
• Study Start: March 26, 2021
• Primary Completion: August 25, 2022
• Study Completion: February 21, 2025
• Last Updated: March 6, 2025
• Results First Posted: May 8, 2024

Record last verified: 2025-02

Locations

US (23)