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
1 other identifier
interventional
174
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-pain
Started Oct 2018
Longer than P75 for not_applicable chronic-pain
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2018
CompletedFirst Posted
Study publicly available on registry
October 1, 2018
CompletedStudy Start
First participant enrolled
October 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2019
CompletedResults Posted
Study results publicly available
November 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2021
CompletedJanuary 11, 2022
December 1, 2021
1.1 years
September 27, 2018
November 4, 2020
December 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
WaveWriter Settings
ACTIVE COMPARATORWaveWriter Programming
Conventional Settings
ACTIVE COMPARATORConventional Programming
Interventions
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.
Eligibility Criteria
You may qualify if:
- Chronic pain of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain.
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Center for Pain and Supportive Care
Phoenix, Arizona, 85028, United States
UCSD Medical Center - Jacobs Medical Center
La Jolla, California, 92037, United States
Denver Back Pain Specialists
Greenwood Village, Colorado, 80111, United States
South Lake Pain Institute, Inc
Clermont, Florida, 34711, United States
Willis-Knighton River Cities Clinical Research Center
Shreveport, Louisiana, 71105, United States
Michigan Pain Consultants
Grand Rapids, Michigan, 49546, United States
Forest Health Medical Center
Ypsilanti, Michigan, 48198, United States
KC Pain Centers
Lee's Summit, Missouri, 64086, United States
Carolinas Research Institute, LLC
Huntersville, North Carolina, 28078, United States
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, 27103, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Toledo Clinic
Toledo, Ohio, 43623, United States
Pacific Sports and Spine, LLC
Eugene, Oregon, 97401, United States
Precision Spine Care
Tyler, Texas, 75701, United States
EvergreenHealth Pain Care
Kirkland, Washington, 98034, United States
Related Publications (1)
Wallace MS, North JM, Phillips GM, Calodney AK, Scowcroft JA, Popat-Lewis BU, Lee JM, Washabaugh EP 3rd, Paez J, Bolash RB, Noles J, Atallah J, Shah B, Ahadian FM, Trainor DM, Chen L, Jain R. Combination therapy with simultaneous delivery of spinal cord stimulation modalities: COMBO randomized controlled trial. Pain Manag. 2023 Mar;13(3):171-184. doi: 10.2217/pmt-2022-0101. Epub 2023 Mar 3.
PMID: 36866658DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Sciences
- Organization
- Boston Scientific
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Wallace, M.D.
University of California, San Diego
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2018
First Posted
October 1, 2018
Study Start
October 3, 2018
Primary Completion
November 5, 2019
Study Completion
December 15, 2021
Last Updated
January 11, 2022
Results First Posted
November 27, 2020
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share