Trial Outcomes & Findings for Evaluation of Clinical Outcomes of Pulse Widths in Spinal Cord Stimulation (NCT NCT03756012)
NCT ID: NCT03756012
Last Updated: 2021-03-08
Results Overview
To evaluate the effect of conventional pulse widths \<500 μsec and pulse widths \>1000 μsec on clinical outcomes during temporary trial as measured by patient defined pain maps.
COMPLETED
NA
15 participants
For 7 days following intervention
2021-03-08
Participant Flow
patients received both doses
Participant milestones
| Measure |
Total Patient Population
This was a case series and all patients received both algorithms; pulse widths \<500 µsec and \>1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population.
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|---|---|
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Overall Study
STARTED
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15
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Overall Study
COMPLETED
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15
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Total Patient Population
n=15 Participants
This was a case series and all patients received both algorithms; pulse widths \<500 µsec and \>1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population.
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.
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|---|---|
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Age, Continuous
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52 years
n=15 Participants
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Sex: Female, Male
Female
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8 Participants
n=15 Participants
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Sex: Female, Male
Male
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7 Participants
n=15 Participants
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PRIMARY outcome
Timeframe: For 7 days following interventionPopulation: Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).
To evaluate the effect of conventional pulse widths \<500 μsec and pulse widths \>1000 μsec on clinical outcomes during temporary trial as measured by patient defined pain maps.
Outcome measures
| Measure |
Total Patient Population
n=15 Participants
This was a case series and all patients received both algorithms; pulse widths \<500 µsec and \>1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population.
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.
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|---|---|
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Effect of Pulse Widths on Pain Clinical Outcomes
Patient subjectively felt coverage was larger with wide pulse width program
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15 Participants
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Effect of Pulse Widths on Pain Clinical Outcomes
Patient subjectively felt coverage was larger with conventional pulse width program
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0 Participants
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SECONDARY outcome
Timeframe: For 7 days following interventionPopulation: Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).
To evaluate the effect of conventional pulse widths \<500μsecand pulse widths and \>1000μsecon clinical outcomes during temporary trial as measured by the number of participants that reported significant change in targeted pain compared to baseline using the NRS at the end of the trial period.
Outcome measures
| Measure |
Total Patient Population
n=15 Participants
This was a case series and all patients received both algorithms; pulse widths \<500 µsec and \>1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population.
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.
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|---|---|
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Change in Targeted Pain
Patient reported no significant change in pain scores/pain relief
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15 Participants
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Change in Targeted Pain
Patient reported significant change in pain scores/pain relief
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0 Participants
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SECONDARY outcome
Timeframe: For 7 days following interventionPopulation: Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).
At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia.
Outcome measures
| Measure |
Total Patient Population
n=15 Participants
This was a case series and all patients received both algorithms; pulse widths \<500 µsec and \>1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population.
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.
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|---|---|
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Distribution of Paesthesia
Larger coverage area with wide pulse width
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15 Participants
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Distribution of Paesthesia
Larger coverage area with conventional pulse width
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0 Participants
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SECONDARY outcome
Timeframe: For 7 days following interventionPopulation: Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).
At the end of the trial period, subjects will be asked to select their favorite program.
Outcome measures
| Measure |
Total Patient Population
n=15 Participants
This was a case series and all patients received both algorithms; pulse widths \<500 µsec and \>1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population.
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.
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|---|---|
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Research Participant Program Preference
Preferred wide pulse width
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9 Participants
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Research Participant Program Preference
preferred conventional pulse width
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6 Participants
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SECONDARY outcome
Timeframe: For 7 days following interventionPopulation: Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).
At the end of the trial period, subjects will be asked to rate the quality of the pain relief achieved during the trial (from either arm) using the following ordinal scale; Excellent, Very Good, Good, Fair or Poor
Outcome measures
| Measure |
Total Patient Population
n=15 Participants
This was a case series and all patients received both algorithms; pulse widths \<500 µsec and \>1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population.
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.
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|---|---|
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Quality of Pain Relief
Poor
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0 Participants
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Quality of Pain Relief
Excellent
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6 Participants
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Quality of Pain Relief
Very Good
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5 Participants
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Quality of Pain Relief
Good
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4 Participants
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Quality of Pain Relief
Fair
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0 Participants
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SECONDARY outcome
Timeframe: For 7 days following interventionPopulation: Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).
At the end of the trial period, subjects will be asked to rate their overall satisfaction with the pain relief achieved during the trial (from either arm) using the following ordinal scale; Very Satisfied, Satisfied, Neither Satisfied nor Unsatisfied, Unsatisfied or Very Unsatisfied
Outcome measures
| Measure |
Total Patient Population
n=15 Participants
This was a case series and all patients received both algorithms; pulse widths \<500 µsec and \>1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population.
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.
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|---|---|
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Research Participant Pain Relief Satisfaction
Very Satisfied
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12 Participants
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Research Participant Pain Relief Satisfaction
Satisfied
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3 Participants
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Research Participant Pain Relief Satisfaction
Neither Satisfied nor Unsatisfied
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0 Participants
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Research Participant Pain Relief Satisfaction
Unsatisfied
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0 Participants
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Research Participant Pain Relief Satisfaction
Very Unsatisfied
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0 Participants
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SECONDARY outcome
Timeframe: For 7 days following interventionPopulation: Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).
Number of patients who achieved ≥ 50% pain relief during the trial (from either arm)
Outcome measures
| Measure |
Total Patient Population
n=15 Participants
This was a case series and all patients received both algorithms; pulse widths \<500 µsec and \>1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population.
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.
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|---|---|
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≥ 50% Pain Relief
Achieved >/= 50% pain relief during the trial (from either arm)
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15 Participants
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≥ 50% Pain Relief
Did not achieve >/= 50% pain relief during the trial (from either arm)
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0 Participants
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SECONDARY outcome
Timeframe: For 7 days following interventionPopulation: was not collected
Rate of device-related and/or procedure-related AEs from SCS implant through study completion or study exit.
Outcome measures
Outcome data not reported
Adverse Events
Total Patient Population
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