Trial Outcomes & Findings for High Rate Spinal Cord Stimulation (SCS) for Chronic Pain (NCT NCT01624740)
NCT ID: NCT01624740
Last Updated: 2015-03-20
Results Overview
Back pain intensity was measured on a 0-10 numerical rating scale (0="no pain", 10="worst pain imaginable") at baseline and following low rate and high rate stimulation. This outcome measure compared the change in intensity from baseline between low rate and high rate stimulation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
For this measure, outcome was assessed at baseline, the end of the first intervention (3 or 4 days post-implantation, depending on the subject), and the end of the second intervention (6 or 8 days post-implantation, depending on the subject).
Results posted on
2015-03-20
Participant Flow
Although 20 subjects enrolled (11 to receive low rate stimulation first, 9 to receive high rate stimulation first), 2 subjects randomized to first receive low rate stimulation were withdrawn prior to stimulation due to difficulties implanting the device. Thus, 18 out of 20 enrolled subjects (9 from each group) started their first intervention.
Participant milestones
| Measure |
Low Rate Followed By High Rate
The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 2 Hz stimulation for 3-4 days, followed by 1200 Hz stimulation for another 3-4 days.
|
High Rate Followed By Low Rate
The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 1200 Hz stimulation for 3-4 days, followed by 2 Hz stimulation for another 3-4 days.
|
|---|---|---|
|
First Intervention (3-4 Days)
STARTED
|
9
|
9
|
|
First Intervention (3-4 Days)
COMPLETED
|
9
|
9
|
|
First Intervention (3-4 Days)
NOT COMPLETED
|
0
|
0
|
|
Washout (1 Hour)
STARTED
|
9
|
9
|
|
Washout (1 Hour)
COMPLETED
|
9
|
9
|
|
Washout (1 Hour)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (3-4 Days)
STARTED
|
9
|
9
|
|
Second Intervention (3-4 Days)
COMPLETED
|
8
|
9
|
|
Second Intervention (3-4 Days)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
High Rate Spinal Cord Stimulation (SCS) for Chronic Pain
Baseline characteristics by cohort
| Measure |
Low Rate Followed By High Rate
n=11 Participants
Precision Plus Spinal Cord Stimulation system: The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 2 Hz stimulation for 3-4 days, followed by 1200 Hz stimulation for another 3-4 days.
|
High Rate Followed By Low Rate
n=9 Participants
Precision Plus Spinal Cord Stimulation system: The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 1200 Hz stimulation for 3-4 days, followed by 2 Hz stimulation for another 3-4 days.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 10.57 • n=5 Participants
|
49.4 years
STANDARD_DEVIATION 9.49 • n=7 Participants
|
56.5 years
STANDARD_DEVIATION 11.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: For this measure, outcome was assessed at baseline, the end of the first intervention (3 or 4 days post-implantation, depending on the subject), and the end of the second intervention (6 or 8 days post-implantation, depending on the subject).Back pain intensity was measured on a 0-10 numerical rating scale (0="no pain", 10="worst pain imaginable") at baseline and following low rate and high rate stimulation. This outcome measure compared the change in intensity from baseline between low rate and high rate stimulation.
Outcome measures
| Measure |
Low Rate Subperception Precision SCS Trial Therapy
n=18 Participants
Stimulation was given at a rate of 2 Hz as either a first or second intervention.
|
High Rate Subperception Precision SCS Trial Therapy
n=17 Participants
Stimulation was given at a rate of 1200 Hz as either a first or second intervention.
|
|---|---|---|
|
Change in Back Pain Intensity
|
20.9 Percent Change From Baseline
Standard Deviation 31.6
|
25.6 Percent Change From Baseline
Standard Deviation 38.1
|
Adverse Events
Trial Lead Insertion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Frequency Stimulation
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
High Frequency Stimulation
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Trial Lead Insertion
n=20 participants at risk
All subjects (n = 20) underwent a lead insertion procedure prior to beginning Period 1 of stimulation. Two of these subjects did not proceed to Period 1 due to insertion difficulties.
|
Low Frequency Stimulation
n=18 participants at risk
Stimulation was given at 2 Hz.
|
High Frequency Stimulation
n=18 participants at risk
Stimulation was given at 1200 Hz.
|
|---|---|---|---|
|
General disorders
Administration Site Condition (Device Stimulation Issues)
|
0.00%
0/20 • 7-9 days
Trial lead insertion was on Day 0, followed by 2 study periods lasting 3-4 days each. Though 18 subjects started stimulation, 20 subjects enrolled and had procedures performed. Two subjects withdrew after attempted lead insertion but before stimulation. Thus, the "At Risk" population during trial lead insertion is reported as 20, not 18.
|
5.6%
1/18 • 7-9 days
Trial lead insertion was on Day 0, followed by 2 study periods lasting 3-4 days each. Though 18 subjects started stimulation, 20 subjects enrolled and had procedures performed. Two subjects withdrew after attempted lead insertion but before stimulation. Thus, the "At Risk" population during trial lead insertion is reported as 20, not 18.
|
22.2%
4/18 • Number of events 4 • 7-9 days
Trial lead insertion was on Day 0, followed by 2 study periods lasting 3-4 days each. Though 18 subjects started stimulation, 20 subjects enrolled and had procedures performed. Two subjects withdrew after attempted lead insertion but before stimulation. Thus, the "At Risk" population during trial lead insertion is reported as 20, not 18.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/20 • 7-9 days
Trial lead insertion was on Day 0, followed by 2 study periods lasting 3-4 days each. Though 18 subjects started stimulation, 20 subjects enrolled and had procedures performed. Two subjects withdrew after attempted lead insertion but before stimulation. Thus, the "At Risk" population during trial lead insertion is reported as 20, not 18.
|
0.00%
0/18 • 7-9 days
Trial lead insertion was on Day 0, followed by 2 study periods lasting 3-4 days each. Though 18 subjects started stimulation, 20 subjects enrolled and had procedures performed. Two subjects withdrew after attempted lead insertion but before stimulation. Thus, the "At Risk" population during trial lead insertion is reported as 20, not 18.
|
5.6%
1/18 • Number of events 1 • 7-9 days
Trial lead insertion was on Day 0, followed by 2 study periods lasting 3-4 days each. Though 18 subjects started stimulation, 20 subjects enrolled and had procedures performed. Two subjects withdrew after attempted lead insertion but before stimulation. Thus, the "At Risk" population during trial lead insertion is reported as 20, not 18.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place