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

Not Applicable

Completed

• Conditions: Chronic Pain

• Registration Number: NCT04676022
• Lead Sponsor: Boston Scientific Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-15
• Study First Posted: 2020-12-19
• Study Start: 2021-03-26
• Primary Completion: 2022-08-25
• Results First Submitted: 2023-09-13
• Results First Submitted QC: 2024-04-12
• Results First Posted: 2024-05-08
• Status Verified: 2025-02
• Study Completion: 2025-02-21
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Responder Rate	3 months post-activation	Proportion of subjects with 50% or greater reduction in overall pain relief

Secondary Outcome Measures

Name	Time	Method
Change in Disability (Oswestry Disability Index)	3-Months post activation	Change in Disability (Oswestry Disability Index). The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The published minimally clinically important difference for change in ODI is 10 points.

Trial Locations

Locations (23)

Vitamed Research; 🇺🇸 Palm Desert, California, United States

Summit Pain Alliance; 🇺🇸 Santa Rosa, California, United States

Denver Back Pain Specialists; 🇺🇸 Greenwood Village, Colorado, United States

South Lake Pain Institute, Inc; 🇺🇸 Clermont, Florida, United States

University of Chicago Hospital; 🇺🇸 Chicago, Illinois, United States

Goodman Campbell Brain and Spine; 🇺🇸 Carmel, Indiana, United States

Crimson Pain Management; 🇺🇸 Overland Park, Kansas, United States

MedPharmics, LLC; 🇺🇸 Metairie, Louisiana, United States

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States

Willis-Knighton River Cities Clinical Research Center; 🇺🇸 Shreveport, Louisiana, United States

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