Combining Mechanisms for Better Outcomes (COMBO) (COMBO)

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: Back Pain; Chronic Pain
• Intervention / Treatment: Device: Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System

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

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Mark Wallace, M.D., University of California, San Diego

Study record dates

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: Pain; Neurologic Manifestations; Chronic Pain
• 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