Trial Outcomes & Findings for VELOCITY: A Study to Characterize Real-World Outcomes of Spinal Cord Stimulation (NCT NCT02741297)

Last Updated: 2021-01-05

Results Overview

Percentage of low back pain responders at 3 months post-activation with no increase in opioids from Baseline to 3 months post-activation

Recruitment status

COMPLETED

Study phase

Target enrollment

73 participants

Primary outcome timeframe

3 months

Results posted on

2021-01-05

Participant milestones
Measure	Spinal Cord Stimulation (SCS) System Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology Spinal Cord Stimulation (SCS) System: Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology
Overall Study STARTED	73
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	14

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Spinal Cord Stimulation (SCS) System n=59 Participants Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology Spinal Cord Stimulation (SCS) System: Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology
Age, Continuous	56.8 years STANDARD_DEVIATION 13.7 • n=59 Participants
Sex: Female, Male Female	42 Participants n=59 Participants
Sex: Female, Male Male	17 Participants n=59 Participants
Average Low Back Pain Scores (NRS)	7.4 units on a scale STANDARD_DEVIATION 1.5 • n=59 Participants

Timeframe: 3 months

Population: For " All subjects without outlier sites", data for those sites with outlier subjects were removed.

Percentage of low back pain responders at 3 months post-activation with no increase in opioids from Baseline to 3 months post-activation

Outcome measures
Measure	Spinal Cord Stimulation (SCS) System n=59 Participants Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology Spinal Cord Stimulation (SCS) System: Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology
Percentage of Low Back Pain Responders All Subjects	25 Participants
Percentage of Low Back Pain Responders All subjects without outliers	23 Participants

Serious events: 6 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events
Measure	Spinal Cord Stimulation (SCS) System n=73 participants at risk Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology Spinal Cord Stimulation (SCS) System: Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology
Cardiac disorders Angina Unstable	1.4% 1/73 • Number of events 1 • Up to 1 year
Cardiac disorders Coronary Artery Disease	1.4% 1/73 • Number of events 1 • Up to 1 year
Musculoskeletal and connective tissue disorders Flank Pain	1.4% 1/73 • Number of events 1 • Up to 1 year
Musculoskeletal and connective tissue disorders Tenosynovitis	1.4% 1/73 • Number of events 1 • Up to 1 year
Gastrointestinal disorders Constipation	1.4% 1/73 • Number of events 1 • Up to 1 year
Hepatobiliary disorders Hepatitis	1.4% 1/73 • Number of events 1 • Up to 1 year
Infections and infestations Pneumonia	1.4% 1/73 • Number of events 1 • Up to 1 year
Vascular disorders Circulatory Collapse	1.4% 1/73 • Number of events 1 • Up to 1 year

Other adverse events
Measure	Spinal Cord Stimulation (SCS) System n=73 participants at risk Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology Spinal Cord Stimulation (SCS) System: Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology
Infections and infestations Implant Site Infection	5.5% 4/73 • Number of events 4 • Up to 1 year

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