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

Chronic Pain Clinical Trial

— SOLIS  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04676022
• Other study ID #: A4077
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 26, 2021
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 241
• Est. completion date: December 2025
• Est. primary completion date: August 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• WaveWriter
To receive Spinal Cord Stimulation programming

Other:
• Conventional Medical Managament
To receive conventional medical management

Locations

Country	Name	City	State
United States	Goodman Campbell Brain and Spine	Carmel	Indiana
United States	Saint Louis Pain Consultants	Chesterfield	Missouri
United States	University of Chicago Hospital	Chicago	Illinois
United States	South Lake Pain Institute, Inc	Clermont	Florida
United States	Institute of Precision Pain Medicine	Corpus Christi	Texas
United States	Pacific Sports and Spine, LLC	Eugene	Oregon
United States	PCPMG Clinical Research Unit, LLC	Greenville	South Carolina
United States	Denver Back Pain Specialists	Greenwood Village	Colorado
United States	Carolinas Research Institute, PLLC	Huntersville	North Carolina
United States	MedPharmics, LLC	Metairie	Louisiana
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Weill Cornell Medical University	New York	New York
United States	Crimson Pain Management	Overland Park	Kansas
United States	Vitamed Research	Palm Desert	California
United States	University of Utah Orthopaedic Center	Salt Lake City	Utah
United States	Summit Pain Alliance	Santa Rosa	California
United States	Willis-Knighton River Cities Clinical Research Center	Shreveport	Louisiana
United States	The Toledo Clinic	Toledo	Ohio
United States	Delaware Valley Pain and Spine Institute	Trevose	Pennsylvania
United States	Precision Spine Care	Tyler	Texas
United States	Novant Health-Hawthorne	Winston-Salem	North Carolina
United States	The Center for Clinical Research	Winston-Salem	North Carolina
United States	Forest Health Medical Center	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder Rate	Proportion of subjects with 50% or greater reduction in overall pain relief	3 months post-activation
Secondary	Change in Disability (Oswestry Disability Index)	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.	3-Months post activation