← Back to Search

Procedure

SCS vs Conventional Management for Chronic Pain (SOLIS Trial)

N/A
Waitlist Available
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test at Screening
Chronic low back pain, with or without leg pain, for at least 6 months
Must not have
Previous failed spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
Require implantation of lead(s) in the cervical epidural space
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post-activation
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the safety and effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities to Conventional Medical Management (CMM) in patients with chronic low back and/or leg pain who have not undergone spinal surgery.

Who is the study for?
This trial is for adults with chronic low back and/or leg pain lasting at least 6 months, who have tried other pain management treatments like medication or physical therapy for over 90 days. Women of childbearing age must not be pregnant. Participants must understand English to give informed consent. Those with vascular-origin pain, cervical lead implant needs, significant cognitive issues, or previous SCS trials are excluded.
What is being tested?
The study compares the effectiveness of Spinal Cord Stimulation (SCS) using Boston Scientific's WaveWriter Systems against Conventional Medical Management (CMM) in managing chronic back/leg pain without spinal surgery. It aims to determine if SCS can be a viable alternative to traditional treatment methods.
What are the potential side effects?
Potential side effects from the SCS procedure may include infection at the site of implantation, bleeding, headache, allergic reaction to materials used in the device, and temporary discomfort or pain where the device is placed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am not pregnant, confirmed by a test.
Select...
I have had chronic low back pain, with or without leg pain, for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a spinal cord stimulation trial that did not work or I have an implant like a pacemaker.
Select...
I need a procedure for leads in my neck area.
Select...
My main pain is due to a blood vessel condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-months post activation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-months post activation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Responder Rate
Secondary study objectives
Change in Disability (Oswestry Disability Index)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Spinal Cord StimulationExperimental Treatment1 Intervention
To receive Spinal Cord Stimulation programming
Group II: Conventional Medical ManagementExperimental Treatment1 Intervention
To receive conventional medical management

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
743 Previous Clinical Trials
857,221 Total Patients Enrolled
32 Trials studying Chronic Pain
63,726 Patients Enrolled for Chronic Pain
Natalie Bloom LyonsStudy DirectorBoston Scientific Corporation
15 Previous Clinical Trials
24,531 Total Patients Enrolled
4 Trials studying Chronic Pain
10,242 Patients Enrolled for Chronic Pain
Roshini JainStudy DirectorBoston Scientific Corporation
30 Previous Clinical Trials
26,058 Total Patients Enrolled
12 Trials studying Chronic Pain
11,267 Patients Enrolled for Chronic Pain

Media Library

WaveWriter (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04676022 — N/A
Chronic Pain Research Study Groups: Spinal Cord Stimulation, Conventional Medical Management
Chronic Pain Clinical Trial 2023: WaveWriter Highlights & Side Effects. Trial Name: NCT04676022 — N/A
WaveWriter (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04676022 — N/A
Chronic Pain Patient Testimony for trial: Trial Name: NCT04676022 — N/A
~53 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top