Combining Mechanisms for Better Outcomes (COMBO)

Chronic Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03689920
• Other study ID #: A4070
• Status: Completed
• Phase: N/A
• Start date: October 3, 2018
• Est. completion date: December 15, 2021

Study information

• Verified date: December 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: December 15, 2021
• Est. primary completion date: November 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
United States	South Lake Pain Institute, Inc	Clermont	Florida
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Pacific Sports and Spine, LLC	Eugene	Oregon
United States	Michigan Pain Consultants	Grand Rapids	Michigan
United States	Denver Back Pain Specialists	Greenwood Village	Colorado
United States	Carolinas Research Institute, LLC	Huntersville	North Carolina
United States	EvergreenHealth Pain Care	Kirkland	Washington
United States	UCSD Medical Center - Jacobs Medical Center	La Jolla	California
United States	KC Pain Centers	Lee's Summit	Missouri
United States	Center for Pain and Supportive Care	Phoenix	Arizona
United States	Willis-Knighton River Cities Clinical Research Center	Shreveport	Louisiana
United States	Toledo Clinic	Toledo	Ohio
United States	Precision Spine Care	Tyler	Texas
United States	The Center for Clinical Research, LLC	Winston-Salem	North Carolina
United States	Forest Health Medical Center	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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