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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post-activation
Awards & highlights

SOLIS Trial 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.Check my eligibility
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.See study design
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.

SOLIS Trial 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.
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I have had chronic low back pain, with or without leg pain, for at least 6 months.

SOLIS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Responder Rate

SOLIS 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
720 Previous Clinical Trials
932,781 Total Patients Enrolled
32 Trials studying Chronic Pain
64,928 Patients Enrolled for Chronic Pain
Roshini JainStudy DirectorBoston Scientific Corporation
30 Previous Clinical Trials
26,054 Total Patients Enrolled
12 Trials studying Chronic Pain
11,267 Patients Enrolled for Chronic Pain
Natalie Bloom LyonsStudy DirectorBoston Scientific Corporation
15 Previous Clinical Trials
24,527 Total Patients Enrolled
4 Trials studying Chronic Pain
10,242 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollment slots still available for this experiment?

"Clinicaltrials.gov confirms that this medical trial, which had its inception on March 26th 2021 and was last updated on November 7th 2022, is not currently recruiting patients. Fortunately, 404 alternative studies are actively seeking subjects at present."

Answered by AI

In what number of health care facilities is this experiment being conducted?

"This medical trial has 23 recruitment sites in total, including Weill Cornell Medical University in New york, Summit Pain Alliance in Santa Rosa, and Delaware Valley Pain and Spine Institute in Trevose. Additionally, multiple other locations are providing enrolment services."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Oregon
Louisiana
Other
How old are they?
65+
18 - 65
What site did they apply to?
Forest Health Medical Center
Summit Pain Alliance
South Lake Pain Institute, Inc
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
1

Why did patients apply to this trial?

I’ve tried pain medication but still hurt. trying to navigate chronic pain - looking at all resources.
PatientReceived 1 prior treatment
I have chronical pain in my low back . This pain involves along my left leg.
PatientReceived 2+ prior treatments
I have tried almost everything and nothing works. All I want is some pain relief. I thought I would give this a shot it can't hurt.
PatientReceived no prior treatments
I have been on numerous Fibromyalgia related medications, along with physical therapy, & alternative treatments with little to no relief.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long do screening visit will take?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery
2021. "SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04676022.
All > Scs > Chronic Pain
~59 spots leftby May 2025
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