Trial Outcomes & Findings for Comparing Long-term Effectiveness of High Frequency and Burst Spinal Cord Stimulation (NCT NCT03681262)
NCT ID: NCT03681262
Last Updated: 2026-05-13
Results Overview
Change from baseline in pain intensity at 12 months. Baseline pain intensity is measured at last CHOIR completion before trial, and is based on patient reported outcome in CHOIR for average pain in the week prior to completion of questionnaire. Score range: 0-10 (higher scores correspond to more severe pain)
ACTIVE_NOT_RECRUITING
NA
7 participants
12 months
2026-05-13
Participant Flow
Participant milestones
| Measure |
High Frequency Spinal Cord Stimulation
Participants receive a high frequency spinal cord stimulation trial, and receive implant if trial is successful
|
Burst Spinal Cord Stimulation
Participants receive a BurstDR spinal cord stimulation trial, and receive implant if trial is successful
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
Received Implant
|
4
|
3
|
|
Overall Study
Completed Month 12 Survey
|
3
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
High Frequency Spinal Cord Stimulation
Participants receive a high frequency spinal cord stimulation trial, and receive implant if trial is successful
|
Burst Spinal Cord Stimulation
Participants receive a BurstDR spinal cord stimulation trial, and receive implant if trial is successful
|
|---|---|---|
|
Overall Study
Continuing on study
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Comparing Long-term Effectiveness of High Frequency and Burst Spinal Cord Stimulation
Baseline characteristics by cohort
| Measure |
High Frequency Spinal Cord Stimulation
n=4 Participants
Participants receive a high frequency spinal cord stimulation trial, and receive implant if trial is successful
|
Burst Spinal Cord Stimulation
n=3 Participants
Participants receive a BurstDR spinal cord stimulation trial, and receive implant if trial is successful
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=1512 Participants
|
3 Participants
n=504 Participants
|
7 Participants
n=2016 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
4 Participants
n=2016 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
3 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=1512 Participants
|
3 Participants
n=504 Participants
|
6 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=1512 Participants
|
3 Participants
n=504 Participants
|
6 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=1512 Participants
|
3 Participants
n=504 Participants
|
7 Participants
n=2016 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Participants who completed the surveys
Change from baseline in pain intensity at 12 months. Baseline pain intensity is measured at last CHOIR completion before trial, and is based on patient reported outcome in CHOIR for average pain in the week prior to completion of questionnaire. Score range: 0-10 (higher scores correspond to more severe pain)
Outcome measures
| Measure |
High Frequency Spinal Cord Stimulation
n=3 Participants
Participants receive a high frequency spinal cord stimulation trial, and receive implant if trial is successful
|
Burst Spinal Cord Stimulation
n=3 Participants
Participants receive a BurstDR spinal cord stimulation trial, and receive implant if trial is successful
|
|---|---|---|
|
Number of Participants With >50% Improvement in Pain Intensity
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants who completed the surveys
Patient global impression of change as Likert scale from 1-5 (higher scores corresponds to more improvement)
Outcome measures
| Measure |
High Frequency Spinal Cord Stimulation
n=3 Participants
Participants receive a high frequency spinal cord stimulation trial, and receive implant if trial is successful
|
Burst Spinal Cord Stimulation
n=3 Participants
Participants receive a BurstDR spinal cord stimulation trial, and receive implant if trial is successful
|
|---|---|---|
|
Number of Participants With Score of 4 or Higher on the Patient Global Impression of Change Survey
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants who completed the surveys
Nuremical rating scale of average pain intensity from 0-10 (higher scores corresponds with more severe pain)
Outcome measures
| Measure |
High Frequency Spinal Cord Stimulation
n=3 Participants
Participants receive a high frequency spinal cord stimulation trial, and receive implant if trial is successful
|
Burst Spinal Cord Stimulation
n=3 Participants
Participants receive a BurstDR spinal cord stimulation trial, and receive implant if trial is successful
|
|---|---|---|
|
Pain Intensity Scale Score
|
4.67 score on a scale
Standard Deviation 0.47
|
5 score on a scale
Standard Deviation 2.94
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants who completed the surveys
NIH (National Institute of health) PROMIS (Patient reported outcomes measure information system) function in t-score with population mean of 50 and standard deviation of 10 (higher scores corresponds with worse function)
Outcome measures
| Measure |
High Frequency Spinal Cord Stimulation
n=3 Participants
Participants receive a high frequency spinal cord stimulation trial, and receive implant if trial is successful
|
Burst Spinal Cord Stimulation
n=3 Participants
Participants receive a BurstDR spinal cord stimulation trial, and receive implant if trial is successful
|
|---|---|---|
|
PROMIS Physical Function T-Score
|
60.67 t-score
Standard Deviation 2.05
|
60.33 t-score
Standard Deviation 4.92
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants who completed the surveys
NIH (National Institute of health) PROMIS (Patient reported outcomes measure information system) pain interference in t-score with population mean of 50 and standard deviation of 10 (higher scores corresponds with worse pain interference)
Outcome measures
| Measure |
High Frequency Spinal Cord Stimulation
n=3 Participants
Participants receive a high frequency spinal cord stimulation trial, and receive implant if trial is successful
|
Burst Spinal Cord Stimulation
n=3 Participants
Participants receive a BurstDR spinal cord stimulation trial, and receive implant if trial is successful
|
|---|---|---|
|
PROMIS Pain Interference T-Score
|
63 t-score
Standard Deviation 2.83
|
58.33 t-score
Standard Deviation 5.25
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants who completed the surveys
NIH (National Institute of health) PROMIS (Patient reported outcomes measure information system) depression in t-score with population mean of 50 and standard deviation of 10 (higher scores corresponds with worse depression)
Outcome measures
| Measure |
High Frequency Spinal Cord Stimulation
n=3 Participants
Participants receive a high frequency spinal cord stimulation trial, and receive implant if trial is successful
|
Burst Spinal Cord Stimulation
n=3 Participants
Participants receive a BurstDR spinal cord stimulation trial, and receive implant if trial is successful
|
|---|---|---|
|
PROMIS Depression T-Score
|
45 t-score
Standard Deviation 12.19
|
46 t-score
Standard Deviation 9.09
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants who completed the surveys
NIH (National Institute of health) PROMIS (Patient reported outcomes measure information system) anxiety in t-score with population mean of 50 and standard deviation of 10 (higher scores corresponds with worse anxiety)
Outcome measures
| Measure |
High Frequency Spinal Cord Stimulation
n=3 Participants
Participants receive a high frequency spinal cord stimulation trial, and receive implant if trial is successful
|
Burst Spinal Cord Stimulation
n=3 Participants
Participants receive a BurstDR spinal cord stimulation trial, and receive implant if trial is successful
|
|---|---|---|
|
PROMIS Anxiety T-Score
|
48.67 t-score
Standard Deviation 7.85
|
46.67 t-score
Standard Deviation 3.3
|
Adverse Events
High Frequency Spinal Cord Stimulation
Burst Spinal Cord Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Frequency Spinal Cord Stimulation
n=4 participants at risk
Participants receive a high frequency spinal cord stimulation trial, and receive implant if trial is successful
|
Burst Spinal Cord Stimulation
n=3 participants at risk
Participants receive a BurstDR spinal cord stimulation trial, and receive implant if trial is successful
|
|---|---|---|
|
Nervous system disorders
Lead Migration
|
25.0%
1/4 • Number of events 1 • up to 12 months
|
0.00%
0/3 • up to 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place