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

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

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 Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Device: WaveWriter; Other: Conventional Medical Managament

• Study Type: Interventional
• Enrollment (Actual): 241
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palm Desert, California, United States, 92260
      • Vitamed Research
    • Santa Rosa, California, United States, 95401
      • Summit Pain Alliance
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • Denver Back Pain Specialists
  • Florida
    • Clermont, Florida, United States, 34711
      • South Lake Pain Institute, Inc
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Hospital
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Goodman Campbell Brain and Spine
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Crimson Pain Management
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • MedPharmics, LLC
    • New Orleans, Louisiana, United States, 70115
      • Ochsner Clinic Foundation
    • Shreveport, Louisiana, United States, 71105
      • Willis-Knighton River Cities Clinical Research Center
  • Michigan
    • Ypsilanti, Michigan, United States, 48198
      • Forest Health Medical Center
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Saint Louis Pain Consultants
  • New York
    • New York, New York, United States, 10022
      • Weill Cornell Medical University
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Carolinas Research Institute, PLLC
    • Winston-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health-Hawthorne
  • Ohio
    • Toledo, Ohio, United States, 43623
      • The Toledo Clinic
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Pacific Sports and Spine, LLC
  • Pennsylvania
    • Trevose, Pennsylvania, United States, 19053
      • Delaware Valley Pain and Spine Institute
  • South Carolina
    • Greenville, South Carolina, United States, 29601
      • PCPMG Clinical Research Unit, LLC
  • Texas
    • Corpus Christi, Texas, United States, 78414
      • Institute of Precision Pain Medicine
    • Tyler, Texas, United States, 75701
      • Precision Spine Care
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Orthopaedic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spinal Cord Stimulation; To receive Spinal Cord Stimulation programming	Device: WaveWriter; To receive Spinal Cord Stimulation programming
Other: Conventional Medical Management; To receive conventional medical management	Other: Conventional Medical Managament; To receive conventional medical management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder Rate	Proportion of subjects with 50% or greater reduction in overall pain relief	3 months post-activation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Study Director: Natalie Bloom Lyons, Boston Scientific Corporation

Publications and helpful links

General Publications

• 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.

Helpful Links

• The SOLIS Study for Low Back Pain

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2021
• Primary Completion (Actual): August 25, 2022
• Study Completion (Actual): February 21, 2025

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Spinal Cord Stimulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: A4077

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes