SCS vs Conventional Management for Chronic Pain

(SOLIS Trial)

Recruiting at 22 trial locations

Overseen By Alexander Chernyak

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Disqualifiers: Vascular pain, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

241 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Natalie Bloom Lyons

Principal Investigator

Boston Scientific Corporation

Eligibility Criteria

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.

Inclusion Criteria

I am not pregnant, confirmed by a test.

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

I have been receiving pain management for my main pain issue for at least 90 days.

Exclusion Criteria

I have had a spinal cord stimulation trial that did not work or I have an implant like a pacemaker.

I need a procedure for leads in my neck area.

My main pain is due to a blood vessel condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Spinal Cord Stimulation or Conventional Medical Management

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Conventional Medical Management
• WaveWriter

Trial Overview 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.

Participant Groups

Group I: Spinal Cord Stimulation Experimental Treatment 1 Intervention

To receive Spinal Cord Stimulation programming

Group II: Conventional Medical Management Experimental Treatment 1 Intervention

To receive conventional medical management

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology