Combining Mechanisms for Better Outcomes (COMBO)

Not Applicable

Completed

• Conditions: Back Pain; Chronic Pain
• Interventions: Device: Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System

• Registration Number: NCT03689920
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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.

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 Timeline

• Study First Submitted: 2018-09-27
• Study First Submitted QC: 2018-09-27
• Study First Posted: 2018-10-01
• Study Start: 2018-10-03
• Primary Completion: 2019-11-05
• Results First Submitted: 2020-11-04
• Results First Submitted QC: 2020-11-04
• Results First Posted: 2020-11-27
• Status Verified: 2021-12
• Study Completion: 2021-12-15
• Last Update Submitted: 2021-12-28
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WaveWriter Settings	Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System	WaveWriter Programming
Conventional Settings	Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System	Conventional Programming

Primary Outcome Measures

Name	Time	Method
Overall Pain Responder Rate	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

Trial Locations

Locations (15)

Willis-Knighton River Cities Clinical Research Center; 🇺🇸 Shreveport, Louisiana, United States

Pacific Sports and Spine, LLC; 🇺🇸 Eugene, Oregon, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Center for Pain and Supportive Care; 🇺🇸 Phoenix, Arizona, United States

UCSD Medical Center - Jacobs Medical Center; 🇺🇸 La Jolla, California, United States

South Lake Pain Institute, Inc; 🇺🇸 Clermont, Florida, United States

Denver Back Pain Specialists; 🇺🇸 Greenwood Village, Colorado, United States

Michigan Pain Consultants; 🇺🇸 Grand Rapids, Michigan, United States

Forest Health Medical Center; 🇺🇸 Ypsilanti, Michigan, United States

The Center for Clinical Research, LLC; 🇺🇸 Winston-Salem, North Carolina, United States

KC Pain Centers; 🇺🇸 Lee's Summit, Missouri, United States

Carolinas Research Institute, LLC; 🇺🇸 Huntersville, North Carolina, United States

Toledo Clinic; 🇺🇸 Toledo, Ohio, United States

Precision Spine Care; 🇺🇸 Tyler, Texas, United States

EvergreenHealth Pain Care; 🇺🇸 Kirkland, Washington, United States