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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04676022
Recruitment Status : Active, not recruiting
First Posted : December 19, 2020
Last Update Posted : February 8, 2023
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 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 : March 26, 2021
Actual Primary Completion Date : August 25, 2022
Estimated Study Completion Date : December 2025

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Spinal Cord Stimulation
To receive Spinal Cord Stimulation programming
 Device: WaveWriter
To receive Spinal Cord Stimulation programming
Conventional Medical Management
To receive conventional medical management
 Other: Conventional Medical Managament
To receive conventional medical management


Outcome Measures
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Primary Outcome Measures :
  1. Responder Rate [ Time Frame: 3 months post-activation ]
    Proportion of subjects with 50% or greater reduction in pain


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04676022


Locations
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Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Study Director: Roshini Jain Boston Scientific Corporation
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT04676022    
Other Study ID Numbers: A4077
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Boston Scientific Corporation:
Spinal Cord Stimulation
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations