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

Primary Purpose

Chronic Pain

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WaveWriter
Conventional Medical Managament
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Spinal Cord Stimulation

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Vitamed Research
  • Summit Pain Alliance
  • Denver Back Pain Specialists
  • South Lake Pain Institute, Inc
  • University of Chicago Hospital
  • Goodman Campbell Brain and Spine
  • Crimson Pain Management
  • MedPharmics, LLC
  • Ochsner Clinic Foundation
  • Willis-Knighton River Cities Clinical Research Center
  • Forest Health Medical Center
  • Saint Louis Pain Consultants
  • Weill Cornell Medical University
  • Carolinas Research Institute, PLLC
  • Novant Health-Hawthorne
  • The Center for Clinical Research
  • The Toledo Clinic
  • Pacific Sports and Spine, LLC
  • Delaware Valley Pain and Spine Institute
  • PCPMG Clinical Research Unit, LLC
  • Institute of Precision Pain Medicine
  • Precision Spine Care
  • University of Utah Orthopaedic Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Spinal Cord Stimulation

Conventional Medical Management

Arm Description

To receive Spinal Cord Stimulation programming

To receive conventional medical management

Outcomes

Primary Outcome Measures

Responder Rate
Proportion of subjects with 50% or greater reduction in pain

Secondary Outcome Measures

Full Information

First Posted
December 15, 2020
Last Updated
August 9, 2023
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04676022
Brief Title
SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 26, 2021 (Actual)
Primary Completion Date
August 25, 2022 (Actual)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Spinal Cord Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
241 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinal Cord Stimulation
Arm Type
Experimental
Arm Description
To receive Spinal Cord Stimulation programming
Arm Title
Conventional Medical Management
Arm Type
Other
Arm Description
To receive conventional medical management
Intervention Type
Device
Intervention Name(s)
WaveWriter
Intervention Description
To receive Spinal Cord Stimulation programming
Intervention Type
Other
Intervention Name(s)
Conventional Medical Managament
Intervention Description
To receive conventional medical management
Primary Outcome Measure Information:
Title
Responder Rate
Description
Proportion of subjects with 50% or greater reduction in pain
Time Frame
3 months post-activation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie Bloom Lyons
Organizational Affiliation
Boston Scientific Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Vitamed Research
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Summit Pain Alliance
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95401
Country
United States
Facility Name
Denver Back Pain Specialists
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
South Lake Pain Institute, Inc
City
Clermont
State/Province
Florida
ZIP/Postal Code
34711
Country
United States
Facility Name
University of Chicago Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Goodman Campbell Brain and Spine
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Crimson Pain Management
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
MedPharmics, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Willis-Knighton River Cities Clinical Research Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Forest Health Medical Center
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48198
Country
United States
Facility Name
Saint Louis Pain Consultants
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Weill Cornell Medical University
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Carolinas Research Institute, PLLC
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Novant Health-Hawthorne
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
The Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
The Toledo Clinic
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Pacific Sports and Spine, LLC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Delaware Valley Pain and Spine Institute
City
Trevose
State/Province
Pennsylvania
ZIP/Postal Code
19053
Country
United States
Facility Name
PCPMG Clinical Research Unit, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Institute of Precision Pain Medicine
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
Facility Name
Precision Spine Care
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
University of Utah Orthopaedic Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34854473
Citation
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.
Results Reference
derived

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

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