Combining Mechanisms for Better Outcomes (COMBO) (COMBO)

December 28, 2021 updated by: Boston Scientific Corporation

Study to Demonstrate the Value of Multiple Modalities and Combining Mechanisms Using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain

To evaluate the effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities as compared to conventional SCS in patients with chronic pain when using the Boston Scientific Spectra WaveWriter SCS System.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To evaluate the effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities as compared to conventional SCS in patients with chronic pain when using the Boston Scientific Spectra WaveWriter SCS System.

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85028
        • Center for Pain and Supportive Care
    • California
      • La Jolla, California, United States, 92037
        • UCSD Medical Center - Jacobs Medical Center
    • Colorado
      • Greenwood Village, Colorado, United States, 80111
        • Denver Back Pain Specialists
    • Florida
      • Clermont, Florida, United States, 34711
        • South Lake Pain Institute, Inc
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • Willis-Knighton River Cities Clinical Research Center
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Michigan Pain Consultants
      • Ypsilanti, Michigan, United States, 48198
        • Forest Health Medical Center
    • Missouri
      • Lee's Summit, Missouri, United States, 64086
        • KC Pain Centers
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Carolinas Research Institute, LLC
      • Winston-Salem, North Carolina, United States, 27103
        • The Center for Clinical Research, LLC
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Pacific Sports and Spine, LLC
    • Texas
      • Tyler, Texas, United States, 75701
        • Precision Spine Care
    • Washington
      • Kirkland, Washington, United States, 98034
        • EvergreenHealth Pain Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Chronic pain of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain.
  • 22 years of age or older at time of enrollment
  • Able to independently read and complete all questionnaires and assessments provided in English
  • Signed a valid, IRB-approved informed consent form (ICF) provided in English

Key Exclusion Criteria:

  • Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes
  • Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
  • Breast-feeding or planning to get pregnant during the course of the study or not using adequate contraception
  • Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: WaveWriter Settings
WaveWriter Programming
Device: Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System
The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.
Active Comparator: Conventional Settings
Conventional Programming
Device: Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System
The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Pain Responder Rate
Time Frame: 3 months post-randomization
Percentage of subjects with 50% or greater reduction from Baseline Visit in average overall pain intensity at 3 months post-randomization with no increase in opioid medications
3 months post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Mark Wallace, M.D., University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2018

Primary Completion (Actual)

November 5, 2019

Study Completion (Actual)

December 15, 2021

Study Registration Dates

First Submitted

September 27, 2018

First Submitted That Met QC Criteria

September 27, 2018

First Posted (Actual)

October 1, 2018

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

December 28, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4070

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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