Trial Outcomes & Findings for Spinal Cord Stimulation in Patients With Post-Laminectomy Syndrome in Testing Phase (NCT NCT03702010)
NCT ID: NCT03702010
Last Updated: 2021-09-01
Results Overview
Visual analogue scale (VAS) at the end of each test phase (either with conventional spinal cord stimulation or with EVOLVE). VAS consists of a 10 centimeter (cm) line, whose ends are defined as the extreme limits of pain (left end corresponds with the absence of pain and the right end with the maximum amount of pain). The patient is asked to point out in the line the place that better correspond to his/her pain, ranging from 0 to 10.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
Baseline, After first stimulation (5days), after washout and second stimulation (12 days), After 30-day follow-up (42 days)
Results posted on
2021-09-01
Participant Flow
Planned enrollment: 24. Final enrollment: 27. Screened: 28.
27 of 28 patients screened were randomized, as one patient did not meet inclusion/exclusion criteria. All patients underwent both treatments, as the study design was cross-section.
Participant milestones
| Measure |
CME - EME Branch
In this study, the conventional spinal cord stimulation method (control Branch-CME branch)
CME control group: after mapping the search for the pain area, the neurostimulator is programmed to conventional stimulation with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days.
The device is then deprogrammed and a 2-day washout period is initiated.
On day 7, EME protocol is initiated: stimulation is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days.
|
EME - CME Branch
In this study, the experimental spinal cord stimulation method are used in the same patient with the EVOLVE programming guide (EME branch)
EME experimental group: fter mapping the search for the pain area, the neurostimulator is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days.
The device is then deprogrammed and a 2-day washout period is initiated.
On day 7, conventional CME stimulation is programmed with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days.
|
|---|---|---|
|
First Stimulation (5 Days)
STARTED
|
13
|
14
|
|
First Stimulation (5 Days)
COMPLETED
|
13
|
14
|
|
First Stimulation (5 Days)
NOT COMPLETED
|
0
|
0
|
|
Washout + Second Stimulation (2+5days)
STARTED
|
13
|
14
|
|
Washout + Second Stimulation (2+5days)
COMPLETED
|
13
|
14
|
|
Washout + Second Stimulation (2+5days)
NOT COMPLETED
|
0
|
0
|
|
Follow-up (30days)
STARTED
|
13
|
14
|
|
Follow-up (30days)
COMPLETED
|
11
|
12
|
|
Follow-up (30days)
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
CME - EME Branch
In this study, the conventional spinal cord stimulation method (control Branch-CME branch)
CME control group: after mapping the search for the pain area, the neurostimulator is programmed to conventional stimulation with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days.
The device is then deprogrammed and a 2-day washout period is initiated.
On day 7, EME protocol is initiated: stimulation is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days.
|
EME - CME Branch
In this study, the experimental spinal cord stimulation method are used in the same patient with the EVOLVE programming guide (EME branch)
EME experimental group: fter mapping the search for the pain area, the neurostimulator is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days.
The device is then deprogrammed and a 2-day washout period is initiated.
On day 7, conventional CME stimulation is programmed with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days.
|
|---|---|---|
|
Follow-up (30days)
Lack of Efficacy
|
2
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CME - EME Branch
n=13 Participants
After mapping the search for the pain area, the neurostimulator is programmed to conventional stimulation (CME) with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days.
The device is then deprogrammed and a 2-day washout period is initiated.
On day 7, EME experimental protocol is initiated: stimulation is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days.
|
EME - CME Branch
n=14 Participants
After mapping the search for the pain area, the neurostimulator is programmed to EME experimental protocol is initiated: stimulation is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days.
The device is then deprogrammed and a 2-day washout period is initiated.
On day 7, conventional stimulation (CME) stimulation is programmed with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.8 years
STANDARD_DEVIATION 13.1 • n=13 Participants
|
53.9 years
STANDARD_DEVIATION 12.6 • n=14 Participants
|
52.4 years
STANDARD_DEVIATION 12.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=13 Participants
|
4 Participants
n=14 Participants
|
10 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=13 Participants
|
10 Participants
n=14 Participants
|
17 Participants
n=27 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Spain
|
13 participants
n=13 Participants
|
14 participants
n=14 Participants
|
27 participants
n=27 Participants
|
|
Body Mass Index (BMI)
|
26.0 kg/m2
STANDARD_DEVIATION 4.3 • n=13 Participants
|
28.2 kg/m2
STANDARD_DEVIATION 4.3 • n=14 Participants
|
27.2 kg/m2
STANDARD_DEVIATION 4.4 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, After first stimulation (5days), after washout and second stimulation (12 days), After 30-day follow-up (42 days)Visual analogue scale (VAS) at the end of each test phase (either with conventional spinal cord stimulation or with EVOLVE). VAS consists of a 10 centimeter (cm) line, whose ends are defined as the extreme limits of pain (left end corresponds with the absence of pain and the right end with the maximum amount of pain). The patient is asked to point out in the line the place that better correspond to his/her pain, ranging from 0 to 10.
Outcome measures
| Measure |
CME -EME Branch
n=13 Participants
Conventional CME: after mapping the search for the pain area, the neurostimulator is programmed to conventional stimulation with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days.
The device is then deprogrammed and a 2-day washout period is initiated.
On day 7, EME protocol is initiated: stimulation is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days.
|
EME-CME Branch
n=14 Participants
EVOLVE programming guide (EME): after mapping the search for the pain area, the neurostimulator is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days
The device is then deprogrammed and a 2-day washout period is initiated.
On day 7, CME protocol is initiated: stimulation is programmed to conventional stimulation with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days.
|
|---|---|---|
|
Comparing Visual Analogue Scale (VAS)
Baseline
|
9.3 score on a scale
Standard Deviation 1.1
|
8.6 score on a scale
Standard Deviation 1.0
|
|
Comparing Visual Analogue Scale (VAS)
After first stimulation (day +5)
|
5.7 score on a scale
Standard Deviation 1.7
|
4.9 score on a scale
Standard Deviation 2.3
|
|
Comparing Visual Analogue Scale (VAS)
After washout and second stimulation (day +12)
|
5.5 score on a scale
Standard Deviation 2.2
|
5.2 score on a scale
Standard Deviation 2.4
|
|
Comparing Visual Analogue Scale (VAS)
After Follow-up (day +42)
|
4.6 score on a scale
Standard Deviation 1.8
|
4.2 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: After first stimulation (Five days after baseline), After second stimulation (12 days after baseline), at the end of follow-up (42 days after baseline)Change (%) in Visual Analogue Scale (VAS) at the end of treatment. * Δ = \[(VAS Initial Visit - VAS Final Visit) / VAS initial visit\] \*100 Please note that positive values indicate a decrease in the VAS scale, which would indicate pain relief, as it was calculated as the value at the earlier time point minus the value at the later time point.
Outcome measures
| Measure |
CME -EME Branch
n=13 Participants
Conventional CME: after mapping the search for the pain area, the neurostimulator is programmed to conventional stimulation with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days.
The device is then deprogrammed and a 2-day washout period is initiated.
On day 7, EME protocol is initiated: stimulation is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days.
|
EME-CME Branch
n=14 Participants
EVOLVE programming guide (EME): after mapping the search for the pain area, the neurostimulator is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days
The device is then deprogrammed and a 2-day washout period is initiated.
On day 7, CME protocol is initiated: stimulation is programmed to conventional stimulation with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days.
|
|---|---|---|
|
Change (%) in VAS Scale at the End of Treatment.
After first stimulation
|
42.4 percentage of VAS change
Standard Deviation 26.0
|
37.4 percentage of VAS change
Standard Deviation 20.6
|
|
Change (%) in VAS Scale at the End of Treatment.
After second stimulation
|
37.8 percentage of VAS change
Standard Deviation 29.1
|
41.5 percentage of VAS change
Standard Deviation 20.3
|
|
Change (%) in VAS Scale at the End of Treatment.
End of follow-up
|
50.1 percentage of VAS change
Standard Deviation 28.1
|
48.8 percentage of VAS change
Standard Deviation 21.5
|
SECONDARY outcome
Timeframe: Baseline, After first stimulation (+5 days), After washout and second stimulation (+12 days), at the end of follow-up (+42days)Oswestry Disability Index of the patients: it is a questionnaire consisting of 10 questions with 6 possible answers each. Every answer gives a punctuation from 0 (less disability) to 5 (more disability). This scale is expressed in percentage in which 0 percentage (%) would the least disability and 100 percentage (%) would represent the maximum disability.
Outcome measures
| Measure |
CME -EME Branch
n=13 Participants
Conventional CME: after mapping the search for the pain area, the neurostimulator is programmed to conventional stimulation with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days.
The device is then deprogrammed and a 2-day washout period is initiated.
On day 7, EME protocol is initiated: stimulation is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days.
|
EME-CME Branch
n=14 Participants
EVOLVE programming guide (EME): after mapping the search for the pain area, the neurostimulator is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days
The device is then deprogrammed and a 2-day washout period is initiated.
On day 7, CME protocol is initiated: stimulation is programmed to conventional stimulation with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days.
|
|---|---|---|
|
Evaluation Disability
Baseline
|
59.8 score on a scale
Standard Deviation 14.1
|
65.7 score on a scale
Standard Deviation 10.5
|
|
Evaluation Disability
After first stimulation
|
44.7 score on a scale
Standard Deviation 15.8
|
41.5 score on a scale
Standard Deviation 21.4
|
|
Evaluation Disability
After second stimulation
|
43.7 score on a scale
Standard Deviation 18.7
|
43.7 score on a scale
Standard Deviation 21.8
|
|
Evaluation Disability
End of Follow-up
|
21.8 score on a scale
Standard Deviation 21.6
|
24.9 score on a scale
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: 42 days from baselineConsidering as an adverse event those that result in death, or in severe harm to patient's health (lesion that threatens life, permanent harm on an organ or corporal function, or process that needs a medical or surgical intervention to avoid permanent harm)
Outcome measures
| Measure |
CME -EME Branch
n=13 Participants
Conventional CME: after mapping the search for the pain area, the neurostimulator is programmed to conventional stimulation with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days.
The device is then deprogrammed and a 2-day washout period is initiated.
On day 7, EME protocol is initiated: stimulation is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days.
|
EME-CME Branch
n=14 Participants
EVOLVE programming guide (EME): after mapping the search for the pain area, the neurostimulator is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days
The device is then deprogrammed and a 2-day washout period is initiated.
On day 7, CME protocol is initiated: stimulation is programmed to conventional stimulation with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days.
|
|---|---|---|
|
Number of Participants With Adverse Events in Each Arm
|
0 Participants
|
0 Participants
|
Adverse Events
CME - Conventional Stimulation
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
EME - EVOLVE Experimental Stimulation
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CME - Conventional Stimulation
n=27 participants at risk
Conventional stimulation with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days.
|
EME - EVOLVE Experimental Stimulation
n=27 participants at risk
The neurostimulator is programmed to stimulation is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days.
|
|---|---|---|
|
Surgical and medical procedures
Pain
|
0.00%
0/27 • From baseline to the end of Follow-up (42 days).
|
3.7%
1/27 • Number of events 1 • From baseline to the end of Follow-up (42 days).
|
|
Surgical and medical procedures
Electrode migration
|
3.7%
1/27 • Number of events 1 • From baseline to the end of Follow-up (42 days).
|
7.4%
2/27 • Number of events 2 • From baseline to the end of Follow-up (42 days).
|
|
Injury, poisoning and procedural complications
post-dural puncture headache
|
3.7%
1/27 • Number of events 1 • From baseline to the end of Follow-up (42 days).
|
3.7%
1/27 • Number of events 1 • From baseline to the end of Follow-up (42 days).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.7%
1/27 • Number of events 1 • From baseline to the end of Follow-up (42 days).
|
0.00%
0/27 • From baseline to the end of Follow-up (42 days).
|
|
Surgical and medical procedures
Abnormal stimulation
|
0.00%
0/27 • From baseline to the end of Follow-up (42 days).
|
3.7%
1/27 • Number of events 1 • From baseline to the end of Follow-up (42 days).
|
Additional Information
Dr. Francisco José Sánchez Montero
Hospital Universitario de Salamanca
Phone: 923291100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place