Combining Mechanisms for Better Outcomes (COMBO)

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03689920
• Collaborator: (none)
• Enrollment: 174
• Locations: 15
• Arms: 2
• Actual Duration (Months): 38.4
• Patients Per Site: 11.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain; Back Pain	Device: Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 174 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 3, 2018
• Actual Primary Completion Date: Nov 5, 2019
• Actual Study Completion Date: Dec 15, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Pain and Supportive Care	Phoenix	Arizona	United States	85028
2	UCSD Medical Center - Jacobs Medical Center	La Jolla	California	United States	92037
3	Denver Back Pain Specialists	Greenwood Village	Colorado	United States	80111
4	South Lake Pain Institute, Inc	Clermont	Florida	United States	34711
5	Willis-Knighton River Cities Clinical Research Center	Shreveport	Louisiana	United States	71105
6	Michigan Pain Consultants	Grand Rapids	Michigan	United States	49546
7	Forest Health Medical Center	Ypsilanti	Michigan	United States	48198
8	KC Pain Centers	Lee's Summit	Missouri	United States	64086
9	Carolinas Research Institute, LLC	Huntersville	North Carolina	United States	28078
10	The Center for Clinical Research, LLC	Winston-Salem	North Carolina	United States	27103
11	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
12	Toledo Clinic	Toledo	Ohio	United States	43623
13	Pacific Sports and Spine, LLC	Eugene	Oregon	United States	97401
14	Precision Spine Care	Tyler	Texas	United States	75701
15	EvergreenHealth Pain Care	Kirkland	Washington	United States	98034

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Mark Wallace, M.D., University of California, San Diego

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 31, 2020

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT03689920
• Other Study ID Numbers: A4070
• First Posted: Oct 1, 2018
• Last Update Posted: Jan 11, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Chronic Pain

Study Results

Participant Flow

Recruitment Details	After subjects were enrolled, they were evaluated per study eligibility criteria. Only those who met all criteria proceeded to receive implant and randomized in the study (as applicable).

Arm/Group Title	WaveWriter Settings	Conventional Settings
Arm/Group Description	WaveWriter Programming 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.	Conventional Programming 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.
Period Title: Overall Study
STARTED	47	52
COMPLETED	41	48
NOT COMPLETED	6	4

Baseline Characteristics

Arm/Group Title	WaveWriter Settings	Conventional Settings	Total
Arm/Group Description	WaveWriter Programming 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.	Conventional Programming 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.	Total of all reporting groups
Overall Participants	47	52	99
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.4 (12.23)	57.8 (12.09)	57.1 (12.1)
Sex: Female, Male (Count of Participants)
Female	30 63.8%	36 69.2%	66 66.7%
Male	17 36.2%	16 30.8%	33 33.3%
Race/Ethnicity, Customized (Count of Participants)
Black, of African Heritage	0 0%	1 1.9%	1 1%
Caucasian	47 100%	49 94.2%	96 97%
Hispanic or Latino	0 0%	1 1.9%	1 1%
Other	0 0%	1 1.9%	1 1%

Outcome Measures

1. Primary Outcome

Title	Overall Pain Responder Rate
Description	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
Time Frame	3 months post-randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	WaveWriter Settings	Conventional Settings
Arm/Group Description	WaveWriter Programming 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.	Conventional Programming 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.
Measure Participants	41	48
Count of Participants [Participants]	36 76.6%	34 65.4%

Adverse Events

Time Frame	Adverse Events were collected up to end of randomized phase (3 months post-randomization)
Adverse Event Reporting Description	Adverse Events including Serious Adverse Events were collected up to end of randomized phase (3 months post-randomization)
Arm/Group Title	WaveWriter Settings		Conventional Settings
Arm/Group Description	WaveWriter Programming 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.		Conventional Programming 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.
All Cause Mortality
	WaveWriter Settings		Conventional Settings
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/48 (0%)
Serious Adverse Events
	WaveWriter Settings		Conventional Settings
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/41 (9.8%)		5/48 (10.4%)
Gastrointestinal disorders
Diarrhoea	1/41 (2.4%)	1	0/48 (0%)	0
General disorders
Non-cardiac chest pain	0/41 (0%)	0	1/48 (2.1%)	1
Hepatobiliary disorders
Cholelithiasis	1/41 (2.4%)	1	0/48 (0%)	0
Infections and infestations
Pneumonia	0/41 (0%)	0	2/48 (4.2%)	2
Metabolism and nutrition disorders
Obesity	1/41 (2.4%)	1	0/48 (0%)	0
Nervous system disorders
Carotid Artery Stenosis	0/41 (0%)	0	1/48 (2.1%)	1
Ischaemic Stroke	0/41 (0%)	0	1/48 (2.1%)	1
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure	1/41 (2.4%)	1	0/48 (0%)	0
Chronic Obstructive Pulmonary Disease	1/41 (2.4%)	1	0/48 (0%)	0
Hypoxia	1/41 (2.4%)	1	0/48 (0%)	0
Other (Not Including Serious) Adverse Events
	WaveWriter Settings		Conventional Settings
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/48 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.