Clinical trial NCT03689920: Combining Mechanisms for Better Outcomes (COMBO)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Back Pain
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2018-10-01
Enrollment: 174
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Pain Responder Rate
timeFrame: 3 months post-randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Center for Pain and Supportive Care
state: Arizona
city: La Jolla
country: United States
facility: UCSD Medical Center - Jacobs Medical Center
state: California
city: Greenwood Village
country: United States
facility: Denver Back Pain Specialists
state: Colorado
city: Clermont
country: United States
facility: South Lake Pain Institute, Inc
state: Florida
city: Shreveport
country: United States
facility: Willis-Knighton River Cities Clinical Research Center
state: Louisiana
city: Grand Rapids
country: United States
facility: Michigan Pain Consultants
state: Michigan
city: Ypsilanti
country: United States
facility: Forest Health Medical Center
state: Michigan
city: Lee's Summit
country: United States
facility: KC Pain Centers
state: Missouri
city: Huntersville
country: United States
facility: Carolinas Research Institute, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center for Clinical Research, LLC
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic
state: Ohio
city: Eugene
country: United States
facility: Pacific Sports and Spine, LLC
state: Oregon
city: Tyler
country: United States
facility: Precision Spine Care
state: Texas
city: Kirkland
country: United States
facility: EvergreenHealth Pain Care
state: Washington
Study officials:
affiliation: University of California, San Diego
name: Mark Wallace, M.D.
role: PRINCIPAL_INVESTIGATOR
References: