Trial Outcomes & Findings for Effect of Pulse Width With Spinal Cord Stimulation (NCT NCT00399516)

Results Overview

Pain severity as measured by NRS quantifies pain, where 0 is "no pain" and 10 is "worst pain imaginable"

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

21 participants

Primary outcome timeframe

Within 6 months post-implantation

Results posted on

2012-04-04

Participant milestones
Measure	Spinal Cord Stimulation Programming Parameters Spinal Cord Stimulation (SCS) treatment group programmed using a randomly assigned sequence of stimulation parameters (i.e. pulse widths)
Overall Study STARTED	21
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	2

Reasons for withdrawal
Measure	Spinal Cord Stimulation Programming Parameters Spinal Cord Stimulation (SCS) treatment group programmed using a randomly assigned sequence of stimulation parameters (i.e. pulse widths)
Overall Study Lost to Follow-up	2

Effect of Pulse Width With Spinal Cord Stimulation

Baseline characteristics by cohort
Measure	Spinal Cord Stimulation Programming Parameters n=21 Participants Spinal Cord Stimulation (SCS) Treatment Group
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age Continuous	53.4 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

Timeframe: Within 6 months post-implantation

Pain severity as measured by NRS quantifies pain, where 0 is "no pain" and 10 is "worst pain imaginable"

Outcome measures
Measure	Spinal Cord Stimulation Programming Parameters n=19 Participants Spinal Cord Stimulation (SCS) treatment group programmed using a randomly assigned sequence of stimulation parameters (i.e. pulse widths)
Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS)	-56.1 Percent Change in Pain Rating Standard Deviation 25.8

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Spinal Cord Stimulation Programming Parameters n=21 participants at risk Spinal Cord Stimulation (SCS) Treatment Group
Nervous system disorders Stimulation not tolerated	4.8% 1/21 • Number of events 1
Nervous system disorders Pain	4.8% 1/21 • Number of events 1

Boston Scientific

Phone: (661) 949-4828

Restriction type: LTE60