COVERAGE: A Study to Evaluate the Effect of Precision Spectra™ Programming Features and Lead Options on Patient Outcomes

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02384096
• Collaborator: (none)
• Enrollment: 17
• Locations: 4
• Arms: 2
• Duration (Months): 20
• Patients Per Site: 4.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The study is a prospective, on-label, multi-center, blinded, randomized controlled trial with a cross-over design to evaluate the effect of Precision Spectra™ SCS System's programming features and lead options.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Device: Conventional single source programming; Device: Precision Spectra SCS System advanced programming	N/A

Detailed Description

The study is a sub-study of RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain (NCT01719055). The treatment will consist of permanent implant of a Precision Spectra™ SCS IPG with either a 32 contact CoverEdge™ Surgical Lead or with more than 2 percutaneous leads after a successful trial. Programming features and lead options of the Precision Spectra™ SCS System will be evaluated up to 3 months post-IPG activation. Following completion of the 3 month visit, subjects will continue to be followed for up to 36 months per the study requirements of the RELIEF Registry.

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: COVERAGE - A Study to Evaluate the Effect of Precision Spectra™ SCS System's Programming Features and Lead Options on Patient Outcomes
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional Programming, then Advanced Programming Precision Spectra SCS System with CoverEdge Surgical Lead or more than 2 percutaneous leads. Subjects first received conventional single source programming followed by Precision Spectra SCS System advanced programming.	Device: Conventional single source programming; Precision Spectra SCS System using conventional single source programming.; Device: Precision Spectra SCS System advanced programming; Precision Spectra SCS System using advanced programming
Active Comparator: Advanced Programming, then Conventional Programming Precision Spectra SCS System with CoverEdge Surgical Lead or more than 2 percutaneous leads. Subjects first received Precision Spectra SCS System advanced programming followed by conventional single source programming.	Device: Conventional single source programming; Precision Spectra SCS System using conventional single source programming.; Device: Precision Spectra SCS System advanced programming; Precision Spectra SCS System using advanced programming

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Paresthesia Coverage ≥50% [7, 14 days post activation]

   Paresthesia Coverage assesses how much of the subject's painful areas are covered by SCS-induced paresthesia. The number of subjects reporting paresthesia coverage ≥50% is reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Meets RELIEF Registry criteria for inclusion

• Primary complaint of persistent or recurrent low back pain, with or without leg pain

• Signed a valid, IRB/EC-approved informed consent form

Exclusion Criteria:

• Meets any RELIEF Registry criteria for exclusion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Physicians Research Group, LLC	Phoenix	Arizona	United States	85016
2	Albany Medical Center	Albany	New York	United States	12208
3	PCPMG Clinical Research Unit, LLC	Greenville	South Carolina	United States	29601
4	Spine Team Texas	Rockwall	Texas	United States	75032

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Study Director: Kristen Lechleiter, M.S., Boston Scientific Neuromodulation Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT02384096
• Other Study ID Numbers: 90968587
• First Posted: Mar 10, 2015
• Last Update Posted: Nov 20, 2020
• Last Verified: Nov 1, 2020

• Keywords provided by Boston Scientific Corporation: stimulation; implantable; pulse generator; back pain; chronic pain; leg pain
• Additional relevant MeSH terms: Chronic Pain

Study Results

Participant Flow

Pre-assignment Detail	17 subjects were enrolled in the study. 5 were withdrawn prior to randomization: 4 were withdrawn as failing to meet inclusion criteria and 1 at the subject's request prior to randomization. 12 were randomized, but 1 was randomized in error and was withdrawn same day. Statistically relevant conclusions cannot be made from this small sample size.

Arm/Group Title	Conventional Programming, Then Advanced Programming	Advanced Programming, Then Conventional Programming
Arm/Group Description	Precision Spectra SCS System with CoverEdge Surgical Lead. Subjects were randomized to first receive conventional single source programming followed by Precision Spectra SCS System advanced programming. Conventional single source programming: Precision Spectra SCS System using conventional single source programming. Precision Spectra SCS System advanced programming: Precision Spectra SCS System using advanced programming.	Precision Spectra SCS System with CoverEdge Surgical Lead. Subjects were randomized to first receive Precision Spectra SCS System advanced programming followed by conventional single source programming. Conventional single source programming: Precision Spectra SCS System using conventional single source programming. Precision Spectra SCS System advanced programming: Precision Spectra SCS System using advanced programming.
Period Title: First Intervention (7 Days)
STARTED	5	7
COMPLETED	4	7
NOT COMPLETED	1	0
Period Title: First Intervention (7 Days)
STARTED	4	7
COMPLETED	4	6
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Conventional Programming, Then Advanced Programming	Advanced Programming, Then Conventional Programming	Total
Arm/Group Description	Precision Spectra SCS System with CoverEdge Surgical Lead. Subjects were randomized to first receive conventional single source programming followed by Precision Spectra SCS System advanced programming. Conventional single source programming: Precision Spectra SCS System using conventional single source programming. Precision Spectra SCS System advanced programming: Precision Spectra SCS System using advanced programming.	Precision Spectra SCS System with CoverEdge Surgical Lead. Subjects were randomized to first receive Precision Spectra SCS System advanced programming followed by conventional single source programming. Conventional single source programming: Precision Spectra SCS System using conventional single source programming. Precision Spectra SCS System advanced programming: Precision Spectra SCS System using advanced programming.	Total of all reporting groups
Overall Participants	5	7	12
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	4 80%	1 14.3%	5 41.7%
>=65 years	1 20%	6 85.7%	7 58.3%
Sex: Female, Male (Count of Participants)
Female	1 20%	3 42.9%	4 33.3%
Male	4 80%	4 57.1%	8 66.7%
Region of Enrollment (participants) [Number]
United States	5 100%	7 100%	12 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Paresthesia Coverage ≥50%
Description	Paresthesia Coverage assesses how much of the subject's painful areas are covered by SCS-induced paresthesia. The number of subjects reporting paresthesia coverage ≥50% is reported.
Time Frame	7, 14 days post activation

Outcome Measure Data

Analysis Population Description

All subjects who completed the day 7 and day 14 post-activation study visits were included. Statistical analysis was not performed as the sample size is too small to draw any statistically relevant conclusions.

Arm/Group Title	Conventional Programming, Then Advanced Programming	Advanced Programming, Then Conventional Programming
Arm/Group Description	Precision Spectra SCS System with CoverEdge Surgical Lead. Subjects were randomized to first receive conventional single source programming followed by Precision Spectra SCS System advanced programming. Conventional single source programming: Precision Spectra SCS System using conventional single source programming. Precision Spectra SCS System advanced programming: Precision Spectra SCS System using advanced programming.	Precision Spectra SCS System with CoverEdge Surgical Lead. Subjects were randomized to first receive Precision Spectra SCS System advanced programming followed by conventional single source programming. Conventional single source programming: Precision Spectra SCS System using conventional single source programming. Precision Spectra SCS System advanced programming: Precision Spectra SCS System using advanced programming.
Measure Participants	4	7
Advanced Programming	3 60%	5 71.4%
Conventional Programming	3 60%	5 71.4%

Adverse Events

Time Frame	From informed consent through completion of study (approximately 3 months)
Adverse Event Reporting Description	Arms/groups are combined instead of reported per intervention because subjects received both programming types (arms) in this crossover study. Additionally, adverse events did not necessarily occur when a subject was receiving one of the two programming types.
Arm/Group Title	All Enrolled Subjects
Arm/Group Description	Rate of device-related adverse events (AEs) and Serious Adverse Events (SAEs) are reported for 17 enrolled subjects from informed consent through completion of study.
All Cause Mortality
	All Enrolled Subjects
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Enrolled Subjects
	Affected / at Risk (%)	# Events
Total	0/17 (0%)
Other (Not Including Serious) Adverse Events
	All Enrolled Subjects
	Affected / at Risk (%)	# Events
Total	2/17 (11.8%)
Infections and infestations
Infection	1/17 (5.9%)	1
Musculoskeletal and connective tissue disorders
Mid back muscle cramps	1/17 (5.9%)	1
Skin and subcutaneous tissue disorders
Rash	1/17 (5.9%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.