Study to Characterize Effects of Programming in SCS Patients Undergoing a Temporary Trial

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02988713
• Collaborator: (none)
• Enrollment: 35
• Locations: 2
• Arm: 1
• Actual Duration (Months): 47.6
• Patients Per Site: 17.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This is a prospective, multi-center, non-randomized, exploratory, single-arm study characterize the effects of programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Device: Programming	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Study to Characterize the Effects of Programming Spinal Cord Stimulation (SCS) in Patients Undergoing a Boston Scientific (BSC) SCS Temporary Trial
• Actual Study Start Date: Dec 13, 2016
• Actual Primary Completion Date: Dec 2, 2020
• Actual Study Completion Date: Dec 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Spinal cord stimulation Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial	Device: Programming; Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial

Outcome Measures

Primary Outcome Measures

1. Patient Comfort [An estimated average of 7 days post temporary trial procedure]

   Number of participants reporting comfort level of stimulation sensation as "Very Comfortable" or "Slightly Comfortable"

Eligibility Criteria

Criteria

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

Key Inclusion Criteria:

• Study candidate is undergoing a spinal cord stimulation (SCS) trial of BSC neurostimulation system, per local directions for use (DFU).

• Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form.

• Subject is 18 years of age or older when written informed consent is obtained.

Key Exclusion Criteria:

• Subject meets any contraindication in BSC neurostimulation system local directions for use (DFU).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pacific Pain Management, Inc.	Ventura	California	United States	93003
2	PCPMG Clinical Research Unit, LLC	Greenville	South Carolina	United States	29601

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Study Director: Roshini Jain, M.S., Boston Scientific Corporation

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 14, 2019

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT02988713
• Other Study ID Numbers: 91153461
• First Posted: Dec 9, 2016
• Last Update Posted: Apr 18, 2022
• Last Verified: Apr 1, 2022

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

Study Results

Participant Flow

Pre-assignment Detail	35 subjects were enrolled in and started the study. 2 were withdrawn prior to the Programming Visit. 33 started the Programming Visit and 32 completed the study. Statistically relevant conclusions cannot be made from this small sample size.

Arm/Group Title	Spinal Cord Stimulation
Arm/Group Description	Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial Programming: Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
Period Title: Overall Study
STARTED	35
COMPLETED	32
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Spinal Cord Stimulation
Arm/Group Description	Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial Programming: Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
Overall Participants	35
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	18 51.4%
>=65 years	17 48.6%
Sex: Female, Male (Count of Participants)
Female	21 60%
Male	14 40%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 2.9%
Not Hispanic or Latino	34 97.1%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	35 100%
Work Status (participants) [Number]
Disability	6 17.1%
Employed	8 22.9%
Retired	14 40%
Student	1 2.9%
Unemployed	6 17.1%
Not reported	1 2.9%

Outcome Measures

1. Primary Outcome

Title	Patient Comfort
Description	Number of participants reporting comfort level of stimulation sensation as "Very Comfortable" or "Slightly Comfortable"
Time Frame	An estimated average of 7 days post temporary trial procedure

Outcome Measure Data

Analysis Population Description

32 subjects completing the Programming Visit

Arm/Group Title	Spinal Cord Stimulation
Arm/Group Description	Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial Programming: Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
Measure Participants	32
Count of Participants [Participants]	30 85.7%

Adverse Events

Time Frame	Adverse events reported from enrollment to end of study (up to 15 days)
Arm/Group Title	Spinal Cord Stimulation
Arm/Group Description	Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial Programming: Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
All Cause Mortality
	Spinal Cord Stimulation
	Affected / at Risk (%)	# Events
Total	0/35 (0%)
Serious Adverse Events
	Spinal Cord Stimulation
	Affected / at Risk (%)	# Events
Total	0/35 (0%)
Other (Not Including Serious) Adverse Events
	Spinal Cord Stimulation
	Affected / at Risk (%)	# Events
Total	0/35 (0%)

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.