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

Sponsor

Boston Scientific Corporation (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04676022

Collaborator

(none)

140

Enrollment

Locations

Arms

56.2

Anticipated Duration (Months)

6.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Device: WaveWriter Other: Conventional Medical Managament	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 26, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Responder Rate [3 months post-activation]
Proportion of subjects with 50% or greater reduction in pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years and Older

Sexes Eligible for Study:

All

Accepts 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 spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)

Contacts and Locations

Locations

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

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

Study Director: Roshini Jain, Boston Scientific Corporation

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

The SOLIS Study for Low Back Pain

Publications

None provided.

Responsible Party:

Boston Scientific Corporation

ClinicalTrials.gov Identifier:

NCT04676022

Other Study ID Numbers:

A4077

First Posted:

Dec 19, 2020

Last Update Posted:

Aug 10, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by Boston Scientific Corporation

Spinal Cord Stimulation

Additional relevant MeSH terms:

Chronic Pain

Study Results

No Results Posted as of Aug 10, 2022