Trial Outcomes & Findings for Spinal Cord Stimulation Frequency Study (NCT NCT01750229)
NCT ID: NCT01750229
Last Updated: 2017-12-18
Results Overview
Visual Analog Scale (VAS) back pain scores were recorded once a day on a multi-day diary, where subjects rate the pain by making a vertical slash mark through the 0-10cm line that best describes their pain during the last 24 hours, with 0 = No pain and 10 = Worst pain imaginable. The higher VAS back pain score represented worse back pain. The average VAS back pain scores from the last three days of diary prior to the follow-up visits were used for analysis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
12 weeks
Results posted on
2017-12-18
Participant Flow
A total of 53 subjects were recruited between January 2013 and April 2015.
A total of 23 subjects discontinued prior to randomization due to eligibility criteria not met or withdrawal from the study.
Participant milestones
| Measure |
All Randomized Subjects
Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
|
|---|---|
|
Randomized Crossover Phase
STARTED
|
30
|
|
Randomized Crossover Phase
Subject Received Sham
|
24
|
|
Randomized Crossover Phase
Subjects Received 1200 Hz
|
24
|
|
Randomized Crossover Phase
Subjects Received 3030 Hz
|
24
|
|
Randomized Crossover Phase
Subjects Received 5882 Hz
|
24
|
|
Randomized Crossover Phase
Protocol Violation
|
4
|
|
Randomized Crossover Phase
COMPLETED
|
28
|
|
Randomized Crossover Phase
NOT COMPLETED
|
2
|
|
Long-term Follow-up Phase
STARTED
|
28
|
|
Long-term Follow-up Phase
COMPLETED
|
25
|
|
Long-term Follow-up Phase
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
All Randomized Subjects
Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
|
|---|---|
|
Randomized Crossover Phase
Adverse Event
|
1
|
|
Randomized Crossover Phase
Withdrawal by Subject
|
1
|
|
Long-term Follow-up Phase
Adverse Event
|
2
|
|
Long-term Follow-up Phase
Withdrawal by Subject
|
1
|
Baseline Characteristics
Spinal Cord Stimulation Frequency Study
Baseline characteristics by cohort
| Measure |
Randomized Phase Subjects
n=24 Participants
Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
|
|---|---|
|
Age, Continuous
|
47.9 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
24 participants
n=5 Participants
|
|
Baseline VAS back pain score
|
7.75 units on a scale
STANDARD_DEVIATION 1.13 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Per-protocol population, subjects who followed the protocol and provided data for all four randomized crossover period were included in the analysis.
Visual Analog Scale (VAS) back pain scores were recorded once a day on a multi-day diary, where subjects rate the pain by making a vertical slash mark through the 0-10cm line that best describes their pain during the last 24 hours, with 0 = No pain and 10 = Worst pain imaginable. The higher VAS back pain score represented worse back pain. The average VAS back pain scores from the last three days of diary prior to the follow-up visits were used for analysis.
Outcome measures
| Measure |
Sham
n=24 Participants
Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
|
1200 Hz
n=24 Participants
Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
|
3030 Hz
n=24 Participants
Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
|
5882 Hz
n=24 Participants
Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
|
|---|---|---|---|---|
|
Visual Analog Scale (VAS) on Back Pain
|
4.83 units on a scale
Standard Deviation 2.45
|
4.51 units on a scale
Standard Deviation 1.87
|
4.57 units on a scale
Standard Deviation 2.09
|
3.22 units on a scale
Standard Deviation 1.98
|
Adverse Events
Sham
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1200 Hz
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
3030 Hz
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
5882 Hz
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sham
n=24 participants at risk
Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
|
1200 Hz
n=24 participants at risk
Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
|
3030 Hz
n=24 participants at risk
Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
|
5882 Hz
n=24 participants at risk
Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
|
|---|---|---|---|---|
|
General disorders
Implant site pain
|
0.00%
0/24 • Randomized crossover phase of 12 weeks
|
4.2%
1/24 • Number of events 1 • Randomized crossover phase of 12 weeks
|
0.00%
0/24 • Randomized crossover phase of 12 weeks
|
0.00%
0/24 • Randomized crossover phase of 12 weeks
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/24 • Randomized crossover phase of 12 weeks
|
0.00%
0/24 • Randomized crossover phase of 12 weeks
|
0.00%
0/24 • Randomized crossover phase of 12 weeks
|
4.2%
1/24 • Number of events 1 • Randomized crossover phase of 12 weeks
|
Other adverse events
| Measure |
Sham
n=24 participants at risk
Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
|
1200 Hz
n=24 participants at risk
Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
|
3030 Hz
n=24 participants at risk
Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
|
5882 Hz
n=24 participants at risk
Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
|
|---|---|---|---|---|
|
General disorders
Implant site pain
|
0.00%
0/24 • Randomized crossover phase of 12 weeks
|
0.00%
0/24 • Randomized crossover phase of 12 weeks
|
8.3%
2/24 • Number of events 2 • Randomized crossover phase of 12 weeks
|
0.00%
0/24 • Randomized crossover phase of 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Trust and/or the PI may prepare the data derived from the study for publication. Data will be submitted to the Sponsor for review and comment prior to publication and at least sixty (60) days prior to submission for publication, public dissemination, or review by a publication committee. All reasonable comments made by the Sponsor in relation to a proposed publication will be incorporated by the Trust and/or the Investigator into the publication.
- Publication restrictions are in place
Restriction type: OTHER