Trial Outcomes & Findings for Direct Comparison of Spinal Cord Stimulator Parameter Settings (NCT NCT05283863)
NCT ID: NCT05283863
Last Updated: 2024-05-21
Results Overview
Assessment of overall degree of back and leg pain during each phase of stimulation (ie conventional baseline stimulation, high-density stimulation, conventional "washout" stimulation, and sham stimulation). Scores range from 0 - 100, with a higher score indicating more pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
8 weeks
Results posted on
2024-05-21
Participant Flow
Participant milestones
| Measure |
High-Frequency Stimulation, Then Placebo Stimulation
Participants first received sub-threshold high-frequency spinal cord stimulation (1200 Hz frequency, 200 μsec pulse width, and an amplitude 90% of the threshold for detection of a sensory percept) for 2 weeks. After a 2-week washout period, they then received sham spinal cord stimulation (1200 Hz at 0 V amplitude) for 2 weeks.
|
Placebo Stimulation, Then High-Frequency Stimulation
Participants first receive sham spinal cord stimulation (1200 Hz at 0 V amplitude) for 2 weeks. After a 2-week washout period, they then receive sub-threshold high-frequency spinal cord stimulation (1200 Hz frequency, 200 μsec pulse width, and an amplitude 90% of the threshold for detection of a sensory percept) for 2 weeks.
|
|---|---|---|
|
First Intervention (14 Days)
STARTED
|
2
|
2
|
|
First Intervention (14 Days)
COMPLETED
|
2
|
2
|
|
First Intervention (14 Days)
NOT COMPLETED
|
0
|
0
|
|
Washout (14 Days)
STARTED
|
2
|
2
|
|
Washout (14 Days)
COMPLETED
|
2
|
2
|
|
Washout (14 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (14 Days)
STARTED
|
2
|
2
|
|
Second Intervention (14 Days)
COMPLETED
|
2
|
2
|
|
Second Intervention (14 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Direct Comparison of Spinal Cord Stimulator Parameter Settings
Baseline characteristics by cohort
| Measure |
High-Frequency Stimulation, Then Placebo Stimulation
n=2 Participants
Participants first receive sub-threshold high-frequency spinal cord stimulation (1200 Hz frequency, 200 μsec pulse width, and an amplitude 90% of the threshold for detection of a sensory percept) for 2 weeks. After a 2-week washout period, they then received sham spinal cord stimulation (1200 Hz at 0 V amplitude) for 2 weeks."
|
Placebo Stimulation, Then High-Frequency Stimulation
n=2 Participants
Participants first receive sham spinal cord stimulation (1200 Hz at 0 V amplitude) for 2 weeks. After a 2-week washout period, they then receive sub-threshold high-frequency spinal cord stimulation (1200 Hz frequency, 200 μsec pulse width, and an amplitude 90% of the threshold for detection of a sensory percept) for 2 weeks.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksAssessment of overall degree of back and leg pain during each phase of stimulation (ie conventional baseline stimulation, high-density stimulation, conventional "washout" stimulation, and sham stimulation). Scores range from 0 - 100, with a higher score indicating more pain.
Outcome measures
| Measure |
High-density Stimulation
n=4 Participants
All patients will receive 2 weeks of conventional spinal cord stimulation as a baseline (60 Hz, 200 usec, at an amplitude above sensory perception). Patients will then be randomly assigned to receive sub-threshold, high-density spinal cord stimulation (1200 Hz, 200 usec, at an amplitude of 90% of the sensory threshold) for 2 weeks. Patients will then get another 2 weeks of conventional stimulation as a "washout" period. Finally, they will get 2 weeks of sham stimulation (1200 Hz, 200 usec, 0 amplitude).
|
Placebo Stimulation
n=4 Participants
All patients will receive 2 weeks of conventional spinal cord stimulation as a baseline (60 Hz, 200 usec, at an amplitude above sensory perception). Patients will then be randomly assigned to receive 2 weeks of sham stimulation (1200 Hz, 200 usec, 0 amplitude). Patients will then get another 2 weeks of conventional stimulation as a "washout" period. Finally, they will get 2 weeks of sub-threshold, high-density spinal cord stimulation (1200 Hz, 200 usec, at an amplitude of 90% of the sensory threshold) for 2 weeks.
|
|---|---|---|
|
Visual Analog Pain Scale
|
2.29 units on a scale
Standard Deviation 0.41
|
6.31 units on a scale
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: 8 weeksThe BPI assesses pain at its "worst," "least," "average," and "now" (current pain). Each item is rated on a scale of 0 - 10 with 10 indicating higher levels of pain. For purposes of this outcome measure, we focused on "now" (current pain)
Outcome measures
| Measure |
High-density Stimulation
n=4 Participants
All patients will receive 2 weeks of conventional spinal cord stimulation as a baseline (60 Hz, 200 usec, at an amplitude above sensory perception). Patients will then be randomly assigned to receive sub-threshold, high-density spinal cord stimulation (1200 Hz, 200 usec, at an amplitude of 90% of the sensory threshold) for 2 weeks. Patients will then get another 2 weeks of conventional stimulation as a "washout" period. Finally, they will get 2 weeks of sham stimulation (1200 Hz, 200 usec, 0 amplitude).
|
Placebo Stimulation
n=4 Participants
All patients will receive 2 weeks of conventional spinal cord stimulation as a baseline (60 Hz, 200 usec, at an amplitude above sensory perception). Patients will then be randomly assigned to receive 2 weeks of sham stimulation (1200 Hz, 200 usec, 0 amplitude). Patients will then get another 2 weeks of conventional stimulation as a "washout" period. Finally, they will get 2 weeks of sub-threshold, high-density spinal cord stimulation (1200 Hz, 200 usec, at an amplitude of 90% of the sensory threshold) for 2 weeks.
|
|---|---|---|
|
Change in Brief Pain Inventory (BPI)
|
-2.0625 units on a scale
Standard Deviation 1.21875
|
1.21875 units on a scale
Standard Deviation 1.555819
|
SECONDARY outcome
Timeframe: 8 weeksThe SF-36 is a measure of quality of life, with scores ranging from 0 - 100, with higher scores indicating a higher quality of life.
Outcome measures
| Measure |
High-density Stimulation
n=4 Participants
All patients will receive 2 weeks of conventional spinal cord stimulation as a baseline (60 Hz, 200 usec, at an amplitude above sensory perception). Patients will then be randomly assigned to receive sub-threshold, high-density spinal cord stimulation (1200 Hz, 200 usec, at an amplitude of 90% of the sensory threshold) for 2 weeks. Patients will then get another 2 weeks of conventional stimulation as a "washout" period. Finally, they will get 2 weeks of sham stimulation (1200 Hz, 200 usec, 0 amplitude).
|
Placebo Stimulation
n=4 Participants
All patients will receive 2 weeks of conventional spinal cord stimulation as a baseline (60 Hz, 200 usec, at an amplitude above sensory perception). Patients will then be randomly assigned to receive 2 weeks of sham stimulation (1200 Hz, 200 usec, 0 amplitude). Patients will then get another 2 weeks of conventional stimulation as a "washout" period. Finally, they will get 2 weeks of sub-threshold, high-density spinal cord stimulation (1200 Hz, 200 usec, at an amplitude of 90% of the sensory threshold) for 2 weeks.
|
|---|---|---|
|
Change in SF-36
|
-28.125 units on a scale
Standard Deviation 19.83001
|
23.125 units on a scale
Standard Deviation 35.90352
|
SECONDARY outcome
Timeframe: 8 weeksThe PVAQ is a measure of vigilance and attention to pain. Total scores can range from 0 to 90, with higher scores indicating more pain vigilance.
Outcome measures
| Measure |
High-density Stimulation
n=4 Participants
All patients will receive 2 weeks of conventional spinal cord stimulation as a baseline (60 Hz, 200 usec, at an amplitude above sensory perception). Patients will then be randomly assigned to receive sub-threshold, high-density spinal cord stimulation (1200 Hz, 200 usec, at an amplitude of 90% of the sensory threshold) for 2 weeks. Patients will then get another 2 weeks of conventional stimulation as a "washout" period. Finally, they will get 2 weeks of sham stimulation (1200 Hz, 200 usec, 0 amplitude).
|
Placebo Stimulation
n=4 Participants
All patients will receive 2 weeks of conventional spinal cord stimulation as a baseline (60 Hz, 200 usec, at an amplitude above sensory perception). Patients will then be randomly assigned to receive 2 weeks of sham stimulation (1200 Hz, 200 usec, 0 amplitude). Patients will then get another 2 weeks of conventional stimulation as a "washout" period. Finally, they will get 2 weeks of sub-threshold, high-density spinal cord stimulation (1200 Hz, 200 usec, at an amplitude of 90% of the sensory threshold) for 2 weeks.
|
|---|---|---|
|
Pain Vigilance and Awareness Questionnaire (PVAQ)
|
46.8 units on a scale
Standard Deviation 7.1
|
51.5 units on a scale
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: No subjects were randomized to the conventional spinal cord stimulation group
Incidence of side effects of stimulation
Outcome measures
| Measure |
High-density Stimulation
n=4 Participants
All patients will receive 2 weeks of conventional spinal cord stimulation as a baseline (60 Hz, 200 usec, at an amplitude above sensory perception). Patients will then be randomly assigned to receive sub-threshold, high-density spinal cord stimulation (1200 Hz, 200 usec, at an amplitude of 90% of the sensory threshold) for 2 weeks. Patients will then get another 2 weeks of conventional stimulation as a "washout" period. Finally, they will get 2 weeks of sham stimulation (1200 Hz, 200 usec, 0 amplitude).
|
Placebo Stimulation
n=4 Participants
All patients will receive 2 weeks of conventional spinal cord stimulation as a baseline (60 Hz, 200 usec, at an amplitude above sensory perception). Patients will then be randomly assigned to receive 2 weeks of sham stimulation (1200 Hz, 200 usec, 0 amplitude). Patients will then get another 2 weeks of conventional stimulation as a "washout" period. Finally, they will get 2 weeks of sub-threshold, high-density spinal cord stimulation (1200 Hz, 200 usec, at an amplitude of 90% of the sensory threshold) for 2 weeks.
|
|---|---|---|
|
Number of Patients With Side Effects of Stimulation
|
2 participants
|
2 participants
|
Adverse Events
High-Frequency Stimulation
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Stimulation
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High-Frequency Stimulation
n=4 participants at risk
Participants received sub-threshold high-frequency spinal cord stimulation (1200 Hz frequency, 200 μsec pulse width, and an amplitude 90% of the threshold for detection of a sensory percept) for 2 weeks.
|
Placebo Stimulation
n=4 participants at risk
Participants received sham spinal cord stimulation (1200 Hz at 0 V amplitude) for 2 weeks.
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|---|---|---|
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Nervous system disorders
Paresthesia
|
50.0%
2/4 • Number of events 2 • 8 weeks
No subjects were enrolled in to the Conventional Spinal Cord Stimulation group
|
50.0%
2/4 • Number of events 2 • 8 weeks
No subjects were enrolled in to the Conventional Spinal Cord Stimulation group
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place