Trial Outcomes & Findings for High Frequency Stimulation Trials in Patients With Precision Spinal Cord Stimulator System (NCT NCT02265848)
NCT ID: NCT02265848
Last Updated: 2016-10-25
Results Overview
Digital pain rating system that scores patient's subjective pain rating from 0 to 10; with greater number indicating progressively worsening pain. NPRS were measured at baseline (visit1), and at each follow ups visits at visit 2, 3 and 4. Visit 2 and 4 captured post treatment (either 1000 Hz or standard stimulation depending on the randomization) results, and visit 3 captured NPRS after the wash off from the spinal cord stimulation.
COMPLETED
PHASE4
22 participants
Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)
2016-10-25
Participant Flow
All study subjects were recruited from the Carolinas Pain Institute who were implanted with Boston Scientific's Precision Plus spinal cord stimulation (SCS) system for chronic axial pain, and at the time of recruitment, was not receiving adequate pain relief from SCS system with baseline numeric pain rating scale of 5 or greater.
Randomization scheme was 1 to 1 ratio. Randomization assignment was generated using random number generator, and individual results were sealed in an envelope. If subject needed to be replaced, the replacement subject will receive the same randomization assignment.
Participant milestones
| Measure |
Treatment Group A
Subjects randomized to the treatment group A will begin the 7 week study "per sequence" (e.g., "High frequency first, then Low frequency" and "Low frequency first, then High frequency"), with each stimulation modes lasting approximately 3 weeks with 7 to 10 days of "wash off" periods in between. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
|
Treatment Group B
Subjects randomized to the treatment group B will begin the 7 week study "per sequence" (e.g., "Low frequency first, then High frequency" and "High frequency first, then Low frequency"), with each stimulation modes lasting approximately 3 weeks with 7 to 10 days of "wash off" periods in between. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
High Frequency Stimulation Trials in Patients With Precision Spinal Cord Stimulator System
Baseline characteristics by cohort
| Measure |
Treatment Group A
n=11 Participants
Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
|
Treatment Group B
n=11 Participants
Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Age, Continuous
|
59 years
n=39 Participants
|
56 years
n=41 Participants
|
57 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=39 Participants
|
11 participants
n=41 Participants
|
22 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)Population: All study subjects were implanted with Boston Scientific's Precision Plus spinal cord stimulation system for treatment of chronic axial pain.
Digital pain rating system that scores patient's subjective pain rating from 0 to 10; with greater number indicating progressively worsening pain. NPRS were measured at baseline (visit1), and at each follow ups visits at visit 2, 3 and 4. Visit 2 and 4 captured post treatment (either 1000 Hz or standard stimulation depending on the randomization) results, and visit 3 captured NPRS after the wash off from the spinal cord stimulation.
Outcome measures
| Measure |
Treatment Group A
n=11 Participants
Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
|
Treatment Group B
n=11 Participants
Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
|
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
Average Baseline NPRS Score
|
6.09 units on a scale
Interval 3.0 to 10.0
|
6.27 units on a scale
Interval 4.0 to 8.0
|
|
Numeric Pain Rating Scale (NPRS)
Average NPRS after Wash off
|
6.45 units on a scale
Interval 4.0 to 10.0
|
7.18 units on a scale
Interval 4.0 to 9.0
|
|
Numeric Pain Rating Scale (NPRS)
Best Baseline NPRS score
|
3.72 units on a scale
Interval 1.0 to 7.0
|
4.45 units on a scale
Interval 2.0 to 7.0
|
|
Numeric Pain Rating Scale (NPRS)
Best NPRS score after 1000 Hz. stimulation
|
2.64 units on a scale
Interval 1.0 to 8.0
|
2.18 units on a scale
Interval 1.0 to 6.0
|
|
Numeric Pain Rating Scale (NPRS)
Best NPRS score after standard stimulation
|
3.46 units on a scale
Interval 1.0 to 6.0
|
4.45 units on a scale
Interval 2.0 to 7.0
|
|
Numeric Pain Rating Scale (NPRS)
Best NPRS after Wash off
|
4.54 units on a scale
Interval 2.0 to 9.0
|
5.36 units on a scale
Interval 1.0 to 8.0
|
|
Numeric Pain Rating Scale (NPRS)
Worst Baseline NPRS score
|
7.90 units on a scale
Interval 6.0 to 10.0
|
8.09 units on a scale
Interval 5.0 to 10.0
|
|
Numeric Pain Rating Scale (NPRS)
Worst NPRS score after standard stimulation
|
8.18 units on a scale
Interval 5.0 to 10.0
|
8.36 units on a scale
Interval 6.0 to 10.0
|
|
Numeric Pain Rating Scale (NPRS)
Average NPRS after 1000 Hz. stimulation
|
3.73 units on a scale
Interval 1.0 to 8.0
|
3.82 units on a scale
Interval 1.0 to 6.0
|
|
Numeric Pain Rating Scale (NPRS)
Average NPRS after standard stimulation
|
5.64 units on a scale
Interval 4.0 to 8.0
|
6.09 units on a scale
Interval 4.0 to 8.0
|
|
Numeric Pain Rating Scale (NPRS)
Worst NPRS score after 1000 Hz. stimulation
|
6.64 units on a scale
Interval 3.0 to 9.0
|
6.64 units on a scale
Interval 3.0 to 10.0
|
|
Numeric Pain Rating Scale (NPRS)
Worst NPRS after Wash off
|
8.72 units on a scale
Interval 6.0 to 10.0
|
8.81 units on a scale
Interval 7.0 to 10.0
|
SECONDARY outcome
Timeframe: Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)Population: All study subjects were implanted with Boston Scientific's Precision Plus spinal cord stimulation system for treatment of chronic axial pain.
ODI is a outcome metrics that is design to assess the severity of disability based on 10 activity categories. ODI is based on 0 to 100% scale, where larger percentage implies worse disability. (There are 5 categories: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippled. 81-100%: Either bed bound or exaggerating symptoms). ODI were measured at baseline (visit1), and at each follow ups visits at visit 2, 3 and 4. Visit 2 and 4 captured post treatment (either 1000 Hz or standard stimulation depending on the randomization) results, and visit 3 captured NPRS after the wash off from the spinal cord stimulation.
Outcome measures
| Measure |
Treatment Group A
n=11 Participants
Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
|
Treatment Group B
n=11 Participants
Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
|
|---|---|---|
|
Oswestry Disability Index Questionnaire (ODI).
ODI after standard stimulation
|
49.63 units on a scale
Interval 28.0 to 70.0
|
49.05 units on a scale
Interval 30.0 to 58.0
|
|
Oswestry Disability Index Questionnaire (ODI).
Baseline ODI score
|
47.49 units on a scale
Interval 24.0 to 68.0
|
51.25 units on a scale
Interval 36.0 to 60.0
|
|
Oswestry Disability Index Questionnaire (ODI).
ODI after 1000 Hz. stimluation
|
39.23 units on a scale
Interval 24.0 to 66.0
|
33.77 units on a scale
Interval 16.0 to 54.0
|
|
Oswestry Disability Index Questionnaire (ODI).
ODI after wash off
|
52.87 units on a scale
Interval 20.0 to 76.0
|
56.77 units on a scale
Interval 32.0 to 78.0
|
SECONDARY outcome
Timeframe: Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)Population: All study subjects were implanted with Boston Scientific's Precision Plus spinal cord stimulation system for treatment of chronic axial pain.
PGIC is a 7-point scale that requires study subjects to rate the severity of their illness or medical condition after a specific treatment. 1: No change, 2: Almost the same, 3: A little better, 4: Somewhat better, 5: Moderately better, 6: Better, 7: A great deal better. Study subjects were asked to report their impression of changes at baseline visit, visit 2 through 4.
Outcome measures
| Measure |
Treatment Group A
n=11 Participants
Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
|
Treatment Group B
n=11 Participants
Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
|
|---|---|---|
|
Patient's Global Impression of Change (PGIC)
PGIC After 1000 Hz. stimulation
|
4.27 units on a scale
Interval 3.0 to 6.0
|
5.91 units on a scale
Interval 4.0 to 7.0
|
|
Patient's Global Impression of Change (PGIC)
PGIC after standard stimulation
|
2.54 units on a scale
Interval 1.0 to 7.0
|
2.45 units on a scale
Interval 1.0 to 6.0
|
|
Patient's Global Impression of Change (PGIC)
PGIC after Wash off
|
1.45 units on a scale
Interval 1.0 to 3.0
|
1.27 units on a scale
Interval 1.0 to 2.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of treatment visit on visit 4Population: All study subjects were implanted with Boston Scientific's Precision Plus spinal cord stimulation system for treatment of chronic axial pain.
At the conclusion of the study, subjects were asked to report which spinal cord stimulation modes they preferred. Subjects were presented with two boxes (1000 Hz. stimulation and Standard stimulation) and asked to check one.
Outcome measures
| Measure |
Treatment Group A
n=11 Participants
Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
|
Treatment Group B
n=11 Participants
Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
|
|---|---|---|
|
Preferability
Subjects who prefer 1000 Hz. stimulation
|
8 participants
|
10 participants
|
|
Preferability
Subjects who prefer standard stimulation
|
3 participants
|
1 participants
|
Adverse Events
Treatment Group A
Treatment Group B
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. James North MD
Center for Clinical Research / Carolinas Pain Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place