Trial Outcomes & Findings for Evaluation of Conventional and Long Pulse Widths During a Temporary Spinal Cord Stimulation Trial (NCT NCT03526055)
NCT ID: NCT03526055
Last Updated: 2019-02-21
Results Overview
The study used a pain relief scale (similar to a brief pain inventory). The scale assessed pain relief using a percent relief rating in 10% increments, where a higher number represents greater pain relief than a lower number for the pain scale. A higher number is considered better for pain relief scale. The scale range is from 0%, which is no relief of pain to 100%, which is complete relief of pain. Subjects are asked to rate their pain by marking the box beside the number that best describes their pain in the last 24 hours.
COMPLETED
NA
10 participants
up to 8 days
2019-02-21
Participant Flow
Participant milestones
| Measure |
<500 µS Pulse Width First, Then >1000 µS Pulse Width
Intervention includes spinal cord stimulation will be programmed to \<500 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject's EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.
Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.
|
>1000 µS Pulse Width First, Then <500 µS Pulse Width
Intervention includes spinal cord stimulation will be programmed to \>1000 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject's EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.
Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.
|
|---|---|---|
|
Initial Program
STARTED
|
5
|
5
|
|
Initial Program
COMPLETED
|
5
|
5
|
|
Initial Program
NOT COMPLETED
|
0
|
0
|
|
Second Program
STARTED
|
5
|
5
|
|
Second Program
COMPLETED
|
5
|
5
|
|
Second Program
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Conventional and Long Pulse Widths During a Temporary Spinal Cord Stimulation Trial
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: up to 8 daysThe study used a pain relief scale (similar to a brief pain inventory). The scale assessed pain relief using a percent relief rating in 10% increments, where a higher number represents greater pain relief than a lower number for the pain scale. A higher number is considered better for pain relief scale. The scale range is from 0%, which is no relief of pain to 100%, which is complete relief of pain. Subjects are asked to rate their pain by marking the box beside the number that best describes their pain in the last 24 hours.
Outcome measures
| Measure |
<500 µS Pulse Width
n=10 Participants
Intervention includes spinal cord stimulation will be programmed to \<500 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject's EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.
Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.
|
>1000 µS Pulse Width
n=10 Participants
Intervention includes spinal cord stimulation will be programmed to \>1000 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject's EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.
Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.
|
|---|---|---|
|
Subject Pain Relief
|
56 percentage of pain relief
Interval 0.0 to 100.0
|
61 percentage of pain relief
Interval 30.0 to 90.0
|
SECONDARY outcome
Timeframe: Up to 8 daysPopulation: This information was not collected.
1\. At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 8 daysPopulation: 1 subject preferred both programs equally.
Subjects will be asked to select their favorite program
Outcome measures
| Measure |
<500 µS Pulse Width
n=10 Participants
Intervention includes spinal cord stimulation will be programmed to \<500 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject's EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.
Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.
|
>1000 µS Pulse Width
n=10 Participants
Intervention includes spinal cord stimulation will be programmed to \>1000 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject's EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.
Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.
|
|---|---|---|
|
Subject Preference
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 8 daysPopulation: This information was not collected.
Subjects will be asked to rate the quality of the pain relief achieved during the trial (from either arm) using the following scale; Excellent, Very Good, Good, Fair or Poor
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 8 daysPopulation: This information was not collected.
Subjects will be asked to rate their overall satisfaction with the pain relief achieved during the trial (from either arm) using the following scale; Very Satisfied, Satisfied, Neither Satisfied nor Unsatisfied, Unsatisfied or Very Unsatisfied
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 8 daysPopulation: 10 patients in total, crossover design.
Number of patients who achieved ≥ 50% pain relief during the trial (from either arm). The study used a pain relief scale (similar to a brief pain inventory). The scale assessed pain relief using a percent relief rating in 10% increments, where a higher number represents greater pain relief than a lower number for the pain scale. A higher number is considered better for pain relief scale.
Outcome measures
| Measure |
<500 µS Pulse Width
n=10 Participants
Intervention includes spinal cord stimulation will be programmed to \<500 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject's EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.
Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.
|
>1000 µS Pulse Width
n=10 Participants
Intervention includes spinal cord stimulation will be programmed to \>1000 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject's EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.
Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.
|
|---|---|---|
|
Achievement of ≥50% Pain Relief
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: From spinal cord stimulation implant through study completion or study exit, Up to 8 daysPopulation: 10 patients total, crossover design
Rate of device-related and/or procedure-related AEs
Outcome measures
| Measure |
<500 µS Pulse Width
n=10 Participants
Intervention includes spinal cord stimulation will be programmed to \<500 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject's EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.
Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.
|
>1000 µS Pulse Width
Intervention includes spinal cord stimulation will be programmed to \>1000 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject's EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.
Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.
|
|---|---|---|
|
Rate of AEs
|
0 participants experienced AE
|
—
|
Adverse Events
<500 μS Pulse Width
>1000 μS Pulse Width
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place