Trial Outcomes & Findings for Spinal Cord Stimulation for Chronic and Intractable Back Pain (NCT NCT00370695)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

12 weeks

Results posted on

2020-12-17

Participant milestones
Measure	Precision Spinal Cord Stimulation System Single arm Precision Spinal Cord Stimulation System. Precision Spinal Cord Stimulation System: Stimulation turned on from implant throughout the Study
Overall Study STARTED	15
Overall Study 12 Weeks Post-activation	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	15

Withdrawal data not reported

Spinal Cord Stimulation for Chronic and Intractable Back Pain

Baseline characteristics by cohort
Measure	Precision Spinal Cord Stimulation System n=15 Participants Single arm Precision Spinal Cord Stimulation System. Precision Spinal Cord Stimulation System: Stimulation turned on from implant throughout the Study
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

Timeframe: 12 weeks

Population: The study was terminated and efforts were made to locate data. No study data are available.

Outcome data not reported

Serious events: 3 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events
Measure	Precision Spinal Cord Stimulation System n=15 participants at risk Single arm Precision Spinal Cord Stimulation System. Precision Spinal Cord Stimulation System: Stimulation turned on from implant throughout the Study
Vascular disorders Popliteal Aneurysm and Clot	6.7% 1/15 • Number of events 1 • Adverse events were collected from enrollment through 52 weeks post-activation or withdrawal.
Infections and infestations Infection	6.7% 1/15 • Number of events 1 • Adverse events were collected from enrollment through 52 weeks post-activation or withdrawal.
Musculoskeletal and connective tissue disorders Leg pain	6.7% 1/15 • Number of events 1 • Adverse events were collected from enrollment through 52 weeks post-activation or withdrawal.

Other adverse events
Measure	Precision Spinal Cord Stimulation System n=15 participants at risk Single arm Precision Spinal Cord Stimulation System. Precision Spinal Cord Stimulation System: Stimulation turned on from implant throughout the Study
Injury, poisoning and procedural complications Increased falling	6.7% 1/15 • Number of events 1 • Adverse events were collected from enrollment through 52 weeks post-activation or withdrawal.
Eye disorders Orbital Ecchymosis	6.7% 1/15 • Number of events 1 • Adverse events were collected from enrollment through 52 weeks post-activation or withdrawal.
Skin and subcutaneous tissue disorders Skin tear	6.7% 1/15 • Number of events 1 • Adverse events were collected from enrollment through 52 weeks post-activation or withdrawal.
Musculoskeletal and connective tissue disorders Pain	6.7% 1/15 • Number of events 1 • Adverse events were collected from enrollment through 52 weeks post-activation or withdrawal.

Boston Scientific

Phone: 6619494350