Trial Outcomes & Findings for Optimized Programming in Spinal Cord Stimulation (SCS) System (NCT NCT00871819)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

Immediately post-procedure

Results posted on

2013-11-27

Participant milestones
Measure	Spinal Cord Stimulation Group Spinal Cord Stimulation (SCS) Treatment Group
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Optimized Programming in Spinal Cord Stimulation (SCS) System

Baseline characteristics by cohort
Measure	Spinal Cord Stimulation Group n=20 Participants Spinal Cord Stimulation (SCS) Treatment Group
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age Continuous	60 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

Timeframe: Immediately post-procedure

Outcome measures
Measure	All Subjects n=20 Participants All enrolled subjects
Correlation Coefficient Between Dorsal Root Paresthesia (Total Pixels Derived From Digital Drawing) at Maximum-comfortable Stimulation Level and Anode-cathode Separation Distance (mm)	0.6202 Correlation coefficient

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Boston Scientific

Phone: (661) 949-4537

Restriction type: LTE60