Trial Outcomes & Findings for Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Analgesia (NCT NCT02898103)
NCT ID: NCT02898103
Last Updated: 2021-04-08
Results Overview
Pain is evaluated on a Numeric Rating Scale: 0-10 scale with 0=no pain and 10=worst imaginable pain. The outcome measure is calculated as such: the pain score 5 and then 10 minutes after the stimulator is first activated on the Numeric Rating Scale divided by the baseline pain score measured on the same scale. Of note, although this is a crossover design, the order of treatment does influence the effects of each treatment, so the 7 total subjects cannot be grouped together for the active portion and then again for the sham portion--they must remain separate, distinct groups even though this is a crossover design.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
5 and 10 minutes after the stimulator is first activated
Results posted on
2021-04-08
Participant Flow
This was a feasibility study and we prospectively chose a convenience sample. We decided that we had enough data from this phase after enrolling 7 subjects for the sciatic leads and therefore closed enrollment and the study.
Participant milestones
| Measure |
Active Then Sham Then Active
electrical current will be introduced to the insulated percutaneous lead(s) for 5 minutes, then sham for 5 minutes, then active current for 2-4 weeks
|
Sham Then Active Electrical Current
sham will be given for 5 minutes followed by active current for 2-4 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Active Then Sham Then Active
n=4 Participants
electrical current will be introduced to the insulated percutaneous lead(s) for 5 minutes, then sham for 5 minutes, then active current for 2-4 weeks
|
Sham Then Active Electrical Current
n=3 Participants
sham will be given for 5 minutes followed by active current for 2-4 weeks
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 3.9 • n=4 Participants
|
48.0 years
STANDARD_DEVIATION 20.8 • n=3 Participants
|
55 years
STANDARD_DEVIATION 14 • n=7 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
6 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=7 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
4 participants
n=4 Participants
|
3 participants
n=3 Participants
|
7 participants
n=7 Participants
|
|
Height
|
67.0 kg
STANDARD_DEVIATION 10.9 • n=4 Participants
|
96.8 kg
STANDARD_DEVIATION 40.2 • n=3 Participants
|
79.8 kg
STANDARD_DEVIATION 29.2 • n=7 Participants
|
|
Body Mass Index
|
25.0 kg/m^2
STANDARD_DEVIATION 3.8 • n=4 Participants
|
30.4 kg/m^2
STANDARD_DEVIATION 5.2 • n=3 Participants
|
27.3 kg/m^2
STANDARD_DEVIATION 5.0 • n=7 Participants
|
PRIMARY outcome
Timeframe: 5 and 10 minutes after the stimulator is first activatedPain is evaluated on a Numeric Rating Scale: 0-10 scale with 0=no pain and 10=worst imaginable pain. The outcome measure is calculated as such: the pain score 5 and then 10 minutes after the stimulator is first activated on the Numeric Rating Scale divided by the baseline pain score measured on the same scale. Of note, although this is a crossover design, the order of treatment does influence the effects of each treatment, so the 7 total subjects cannot be grouped together for the active portion and then again for the sham portion--they must remain separate, distinct groups even though this is a crossover design.
Outcome measures
| Measure |
Electrical Current
n=4 Participants
electrical current will be introduced to the insulated percutaneous lead(s) for 5 minutes
Ultrasound-guided percutaneous peripheral nerve stimulation: Using ultrasound guidance, the small electrical lead is inserted adjacent to a target peripheral nerve through a percutaneously introduced 20-gauge needle. Following needle withdrawal, the percutaneous lead is attached to a miniature stimulator half the size of a business card that is simply adhered to the skin. When activated, the (active) stimulator generates a small electrical current which passes through the insulated leads to the uninsulated lead tip, which activates nerve fibers (placebo stimulators do not generate current).
|
Placebo
n=3 Participants
NO electrical current will be introduced to the insulated percutaneous lead(s) for 5 minutes
Ultrasound-guided percutaneous peripheral nerve stimulation: Using ultrasound guidance, the small electrical lead is inserted adjacent to a target peripheral nerve through a percutaneously introduced 20-gauge needle. Following needle withdrawal, the percutaneous lead is attached to a miniature stimulator half the size of a business card that is simply adhered to the skin. When activated, the (active) stimulator generates a small electrical current which passes through the insulated leads to the uninsulated lead tip, which activates nerve fibers (placebo stimulators do not generate current).
|
|---|---|---|
|
Change From Baseline of Surgical Site Pain Level (NRS) at Rest [Percentage of Baseline Pain]
5 Minutes after baseline just before 1st intervention
|
64 percentage of baseline
Interval 28.0 to 100.0
|
100 percentage of baseline
Interval 100.0 to 100.0
|
|
Change From Baseline of Surgical Site Pain Level (NRS) at Rest [Percentage of Baseline Pain]
10 minutes after baseline (which was just before 1st intervention)
|
55 percentage of baseline
Interval 33.0 to 71.0
|
69 percentage of baseline
Interval 33.0 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Two minutes following stimulation initiation following lead insertionStrength is evaluated using an isometric force electromechanical dynamometer to measure the force produced during a maximum voluntary isometric contraction during plantar flexion. The outcome measure is calculated as such: the force produced after the stimulator is activated divided by the baseline force prior to stimulation initiation. Of note, although this is a crossover design, the order of treatment does influence the effects of each treatment, so the 7 total subjects cannot be grouped together for the active portion and then again for the sham portion--they must remain separate, distinct groups even though this is a crossover design.
Outcome measures
| Measure |
Electrical Current
n=4 Participants
electrical current will be introduced to the insulated percutaneous lead(s) for 5 minutes
Ultrasound-guided percutaneous peripheral nerve stimulation: Using ultrasound guidance, the small electrical lead is inserted adjacent to a target peripheral nerve through a percutaneously introduced 20-gauge needle. Following needle withdrawal, the percutaneous lead is attached to a miniature stimulator half the size of a business card that is simply adhered to the skin. When activated, the (active) stimulator generates a small electrical current which passes through the insulated leads to the uninsulated lead tip, which activates nerve fibers (placebo stimulators do not generate current).
|
Placebo
n=3 Participants
NO electrical current will be introduced to the insulated percutaneous lead(s) for 5 minutes
Ultrasound-guided percutaneous peripheral nerve stimulation: Using ultrasound guidance, the small electrical lead is inserted adjacent to a target peripheral nerve through a percutaneously introduced 20-gauge needle. Following needle withdrawal, the percutaneous lead is attached to a miniature stimulator half the size of a business card that is simply adhered to the skin. When activated, the (active) stimulator generates a small electrical current which passes through the insulated leads to the uninsulated lead tip, which activates nerve fibers (placebo stimulators do not generate current).
|
|---|---|---|
|
Percentage of Baseline Muscle Strength
|
1.0 percentage of baseline muscle strength
Standard Deviation 2.1
|
-2.3 percentage of baseline muscle strength
Standard Deviation 3.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Daily for Days 1-14 following surgery, then at 30 and 90 daysPain level evaluated with a 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain. Both treatment groups are receiving active stimulation from 10 minutes following baseline until the leads are removed 2-4 weeks following baseline. However, we do not know if the order of the first 10 minutes of treatment (either sham then stimulation or stimulation then sham) affects subsequent effects. Therefore, these two treatment groups must remain separate for the remainder of the study period (even though both treatment groups are receiving the same intervention on each of the days described here).
Outcome measures
| Measure |
Electrical Current
n=4 Participants
electrical current will be introduced to the insulated percutaneous lead(s) for 5 minutes
Ultrasound-guided percutaneous peripheral nerve stimulation: Using ultrasound guidance, the small electrical lead is inserted adjacent to a target peripheral nerve through a percutaneously introduced 20-gauge needle. Following needle withdrawal, the percutaneous lead is attached to a miniature stimulator half the size of a business card that is simply adhered to the skin. When activated, the (active) stimulator generates a small electrical current which passes through the insulated leads to the uninsulated lead tip, which activates nerve fibers (placebo stimulators do not generate current).
|
Placebo
n=3 Participants
NO electrical current will be introduced to the insulated percutaneous lead(s) for 5 minutes
Ultrasound-guided percutaneous peripheral nerve stimulation: Using ultrasound guidance, the small electrical lead is inserted adjacent to a target peripheral nerve through a percutaneously introduced 20-gauge needle. Following needle withdrawal, the percutaneous lead is attached to a miniature stimulator half the size of a business card that is simply adhered to the skin. When activated, the (active) stimulator generates a small electrical current which passes through the insulated leads to the uninsulated lead tip, which activates nerve fibers (placebo stimulators do not generate current).
|
|---|---|---|
|
Worst Pain at Rest
Day 14 following intervention
|
2.5 score on a scale
Standard Deviation 2.3
|
0 score on a scale
Standard Deviation 0
|
|
Worst Pain at Rest
Day 1 following intervention
|
1.7 score on a scale
Standard Deviation 1.5
|
0.7 score on a scale
Standard Deviation 1.2
|
|
Worst Pain at Rest
Day 2 following intervention
|
2.7 score on a scale
Standard Deviation 2.5
|
3.0 score on a scale
Standard Deviation 3.0
|
|
Worst Pain at Rest
Day 3 following intervention
|
1.3 score on a scale
Standard Deviation 1.2
|
1.0 score on a scale
Standard Deviation 1.0
|
|
Worst Pain at Rest
Day 4 following intervention
|
0.7 score on a scale
Standard Deviation 1.2
|
0.7 score on a scale
Standard Deviation 1.2
|
|
Worst Pain at Rest
Day 5 following intervention
|
1.3 score on a scale
Standard Deviation 2.3
|
1.3 score on a scale
Standard Deviation 0.6
|
|
Worst Pain at Rest
Day 6 following intervention
|
1.3 score on a scale
Standard Deviation 2.3
|
1.0 score on a scale
Standard Deviation 1.0
|
|
Worst Pain at Rest
Day 7 following intervention
|
2.7 score on a scale
Standard Deviation 2.3
|
0.3 score on a scale
Standard Deviation 0.6
|
|
Worst Pain at Rest
Day 8 following intervention
|
3.0 score on a scale
Standard Deviation 2.6
|
0 score on a scale
Standard Deviation 0
|
|
Worst Pain at Rest
Day 9 following intervention
|
2.3 score on a scale
Standard Deviation 2.1
|
0 score on a scale
Standard Deviation 0
|
|
Worst Pain at Rest
Day 10 following intervention
|
2.3 score on a scale
Standard Deviation 2.1
|
0 score on a scale
Standard Deviation 0
|
|
Worst Pain at Rest
Day 11 following intervention
|
3.3 score on a scale
Standard Deviation 3.1
|
0 score on a scale
Standard Deviation 0
|
|
Worst Pain at Rest
Day 12 following intervention
|
3.0 score on a scale
Standard Deviation 2.6
|
0 score on a scale
Standard Deviation 0
|
|
Worst Pain at Rest
Day 13 following intervention
|
2.3 score on a scale
Standard Deviation 2.1
|
0 score on a scale
Standard Deviation 0
|
|
Worst Pain at Rest
Day 30 following intervention
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Worst Pain at Rest
Day 90 following intervention
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Daily for days 1-14 following surgery, then at 30 and 90 daysPain level evaluated with a 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain. Both treatment groups are receiving active stimulation from 10 minutes following baseline until the leads are removed 2-4 weeks following baseline. However, we do not know if the order of the first 10 minutes of treatment (either sham then stimulation or stimulation then sham) affects subsequent effects. Therefore, these two treatment groups must remain separate for the remainder of the study period (even though both treatment groups are receiving the same intervention on each of the days described here).
Outcome measures
| Measure |
Electrical Current
n=4 Participants
electrical current will be introduced to the insulated percutaneous lead(s) for 5 minutes
Ultrasound-guided percutaneous peripheral nerve stimulation: Using ultrasound guidance, the small electrical lead is inserted adjacent to a target peripheral nerve through a percutaneously introduced 20-gauge needle. Following needle withdrawal, the percutaneous lead is attached to a miniature stimulator half the size of a business card that is simply adhered to the skin. When activated, the (active) stimulator generates a small electrical current which passes through the insulated leads to the uninsulated lead tip, which activates nerve fibers (placebo stimulators do not generate current).
|
Placebo
n=3 Participants
NO electrical current will be introduced to the insulated percutaneous lead(s) for 5 minutes
Ultrasound-guided percutaneous peripheral nerve stimulation: Using ultrasound guidance, the small electrical lead is inserted adjacent to a target peripheral nerve through a percutaneously introduced 20-gauge needle. Following needle withdrawal, the percutaneous lead is attached to a miniature stimulator half the size of a business card that is simply adhered to the skin. When activated, the (active) stimulator generates a small electrical current which passes through the insulated leads to the uninsulated lead tip, which activates nerve fibers (placebo stimulators do not generate current).
|
|---|---|---|
|
Average Pain at Rest
Day 4 following intervention
|
0.3 score on a scale
Standard Deviation 0.6
|
0 score on a scale
Standard Deviation 0
|
|
Average Pain at Rest
Day 6 following intervention
|
0.3 score on a scale
Standard Deviation 0.6
|
0 score on a scale
Standard Deviation 0
|
|
Average Pain at Rest
Day 1 following intervention
|
0.5 score on a scale
Standard Deviation 0.5
|
0 score on a scale
Standard Deviation 0
|
|
Average Pain at Rest
Day 2 following intervention
|
1.3 score on a scale
Standard Deviation 1.2
|
0.7 score on a scale
Standard Deviation 1.2
|
|
Average Pain at Rest
Day 3 following intervention
|
1.3 score on a scale
Standard Deviation 1.2
|
0.3 score on a scale
Standard Deviation 0.6
|
|
Average Pain at Rest
Day 5 following intervention
|
0.3 score on a scale
Standard Deviation 0.6
|
0 score on a scale
Standard Deviation 0
|
|
Average Pain at Rest
Day 7 following intervention
|
0.3 score on a scale
Standard Deviation 0.6
|
0 score on a scale
Standard Deviation 0
|
|
Average Pain at Rest
Day 8 following intervention
|
0.3 score on a scale
Standard Deviation 0.6
|
0 score on a scale
Standard Deviation 0
|
|
Average Pain at Rest
Day 9 following intervention
|
1.0 score on a scale
Standard Deviation 1.0
|
0 score on a scale
Standard Deviation 0
|
|
Average Pain at Rest
Day 10 following intervention
|
1.0 score on a scale
Standard Deviation 1.0
|
0 score on a scale
Standard Deviation 0
|
|
Average Pain at Rest
Day 11 following intervention
|
1.3 score on a scale
Standard Deviation 1.5
|
0 score on a scale
Standard Deviation 0
|
|
Average Pain at Rest
Day 12 following intervention
|
1.0 score on a scale
Standard Deviation 1.0
|
0 score on a scale
Standard Deviation 0
|
|
Average Pain at Rest
Day 13 following intervention
|
1.0 score on a scale
Standard Deviation 1.0
|
0 score on a scale
Standard Deviation 0
|
|
Average Pain at Rest
Day 14 following intervention
|
1.0 score on a scale
Standard Deviation 1.0
|
0 score on a scale
Standard Deviation 0
|
|
Average Pain at Rest
Day 30 following intervention
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Average Pain at Rest
Day 90 following intervention
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Daily for Days 1-14 following surgery, then at 30 and 90 daysPain level evaluated with a 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain. Both treatment groups are receiving active stimulation from 10 minutes following baseline until the leads are removed 2-4 weeks following baseline. However, we do not know if the order of the first 10 minutes of treatment (either sham then stimulation or stimulation then sham) affects subsequent effects. Therefore, these two treatment groups must remain separate for the remainder of the study period (even though both treatment groups are receiving the same intervention on each of the days described here).
Outcome measures
| Measure |
Electrical Current
n=4 Participants
electrical current will be introduced to the insulated percutaneous lead(s) for 5 minutes
Ultrasound-guided percutaneous peripheral nerve stimulation: Using ultrasound guidance, the small electrical lead is inserted adjacent to a target peripheral nerve through a percutaneously introduced 20-gauge needle. Following needle withdrawal, the percutaneous lead is attached to a miniature stimulator half the size of a business card that is simply adhered to the skin. When activated, the (active) stimulator generates a small electrical current which passes through the insulated leads to the uninsulated lead tip, which activates nerve fibers (placebo stimulators do not generate current).
|
Placebo
n=3 Participants
NO electrical current will be introduced to the insulated percutaneous lead(s) for 5 minutes
Ultrasound-guided percutaneous peripheral nerve stimulation: Using ultrasound guidance, the small electrical lead is inserted adjacent to a target peripheral nerve through a percutaneously introduced 20-gauge needle. Following needle withdrawal, the percutaneous lead is attached to a miniature stimulator half the size of a business card that is simply adhered to the skin. When activated, the (active) stimulator generates a small electrical current which passes through the insulated leads to the uninsulated lead tip, which activates nerve fibers (placebo stimulators do not generate current).
|
|---|---|---|
|
Worst Pain During Movement
Day 1 following intervention
|
2.7 score on a scale
Standard Deviation 2.3
|
0.7 score on a scale
Standard Deviation 1.2
|
|
Worst Pain During Movement
Day 2 following intervention
|
4.2 score on a scale
Standard Deviation 3.7
|
2.7 score on a scale
Standard Deviation 3.8
|
|
Worst Pain During Movement
Day 3 following intervention
|
3.0 score on a scale
Standard Deviation 2.6
|
1.0 score on a scale
Standard Deviation 1.0
|
|
Worst Pain During Movement
Day 4 following intervention
|
2.0 score on a scale
Standard Deviation 2.0
|
0.7 score on a scale
Standard Deviation 1.2
|
|
Worst Pain During Movement
Day 5 following intervention
|
2.0 score on a scale
Standard Deviation 2.0
|
1.3 score on a scale
Standard Deviation 0.6
|
|
Worst Pain During Movement
Day 6 following intervention
|
2 score on a scale
Standard Deviation 2
|
1 score on a scale
Standard Deviation 1
|
|
Worst Pain During Movement
Day 7 following intervention
|
2.7 score on a scale
Standard Deviation 2.3
|
0.3 score on a scale
Standard Deviation 0.6
|
|
Worst Pain During Movement
Day 8 following intervention
|
3.3 score on a scale
Standard Deviation 3.1
|
0 score on a scale
Standard Deviation 0
|
|
Worst Pain During Movement
Day 9 following intervention
|
2.7 score on a scale
Standard Deviation 2.3
|
0 score on a scale
Standard Deviation 0
|
|
Worst Pain During Movement
Day 10 following intervention
|
3.0 score on a scale
Standard Deviation 2.6
|
0 score on a scale
Standard Deviation 0
|
|
Worst Pain During Movement
Day 11 following intervention
|
3.7 score on a scale
Standard Deviation 3.2
|
0 score on a scale
Standard Deviation 0
|
|
Worst Pain During Movement
Day 12 following intervention
|
3.3 score on a scale
Standard Deviation 2.9
|
0 score on a scale
Standard Deviation 0
|
|
Worst Pain During Movement
Day 13 following intervention
|
3 score on a scale
Standard Deviation 2.6
|
0 score on a scale
Standard Deviation 0
|
|
Worst Pain During Movement
Day 14 following intervention
|
3 score on a scale
Standard Deviation 2.6
|
0 score on a scale
Standard Deviation 0
|
|
Worst Pain During Movement
Day 30 following intervention
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Worst Pain During Movement
Day 90 following intervention
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Daily for Days 1-14 following surgery, and then at 30 and 90 daysPain level evaluated with a 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain. Both treatment groups are receiving active stimulation from 10 minutes following baseline until the leads are removed 2-4 weeks following baseline. However, we do not know if the order of the first 10 minutes of treatment (either sham then stimulation or stimulation then sham) affects subsequent effects. Therefore, these two treatment groups must remain separate for the remainder of the study period (even though both treatment groups are receiving the same intervention on each of the days described here).
Outcome measures
| Measure |
Electrical Current
n=4 Participants
electrical current will be introduced to the insulated percutaneous lead(s) for 5 minutes
Ultrasound-guided percutaneous peripheral nerve stimulation: Using ultrasound guidance, the small electrical lead is inserted adjacent to a target peripheral nerve through a percutaneously introduced 20-gauge needle. Following needle withdrawal, the percutaneous lead is attached to a miniature stimulator half the size of a business card that is simply adhered to the skin. When activated, the (active) stimulator generates a small electrical current which passes through the insulated leads to the uninsulated lead tip, which activates nerve fibers (placebo stimulators do not generate current).
|
Placebo
n=3 Participants
NO electrical current will be introduced to the insulated percutaneous lead(s) for 5 minutes
Ultrasound-guided percutaneous peripheral nerve stimulation: Using ultrasound guidance, the small electrical lead is inserted adjacent to a target peripheral nerve through a percutaneously introduced 20-gauge needle. Following needle withdrawal, the percutaneous lead is attached to a miniature stimulator half the size of a business card that is simply adhered to the skin. When activated, the (active) stimulator generates a small electrical current which passes through the insulated leads to the uninsulated lead tip, which activates nerve fibers (placebo stimulators do not generate current).
|
|---|---|---|
|
Average Pain During Movement
Day 1 following intervention
|
1.2 score on a scale
Standard Deviation 1.6
|
0 score on a scale
Standard Deviation 0
|
|
Average Pain During Movement
Day 2 following intervention
|
2 score on a scale
Standard Deviation 2
|
0.7 score on a scale
Standard Deviation 1.2
|
|
Average Pain During Movement
Day 3 following intervention
|
2.3 score on a scale
Standard Deviation 2.1
|
0.7 score on a scale
Standard Deviation 1.2
|
|
Average Pain During Movement
Day 4 following intervention
|
1 score on a scale
Standard Deviation 1
|
0.3 score on a scale
Standard Deviation 0.6
|
|
Average Pain During Movement
Day 5 following intervention
|
1.2 score on a scale
Standard Deviation 1.3
|
0.3 score on a scale
Standard Deviation 0.6
|
|
Average Pain During Movement
Day 6 following intervention
|
0.7 score on a scale
Standard Deviation 1.2
|
0 score on a scale
Standard Deviation 0
|
|
Average Pain During Movement
Day 7 following intervention
|
1.8 score on a scale
Standard Deviation 16
|
0 score on a scale
Standard Deviation 0
|
|
Average Pain During Movement
Day 8 following intervention
|
1.7 score on a scale
Standard Deviation 1.5
|
0 score on a scale
Standard Deviation 0
|
|
Average Pain During Movement
Day 9 following intervention
|
1.7 score on a scale
Standard Deviation 1.5
|
0 score on a scale
Standard Deviation 0
|
|
Average Pain During Movement
Day 10 following intervention
|
1.7 score on a scale
Standard Deviation 1.5
|
0 score on a scale
Standard Deviation 0
|
|
Average Pain During Movement
Day 11 following intervention
|
1.8 score on a scale
Standard Deviation 1.6
|
0 score on a scale
Standard Deviation 0
|
|
Average Pain During Movement
Day 12 following intervention
|
2 score on a scale
Standard Deviation 1.7
|
0 score on a scale
Standard Deviation 0
|
|
Average Pain During Movement
Day 13 following intervention
|
1.3 score on a scale
Standard Deviation 1.2
|
0 score on a scale
Standard Deviation 0
|
|
Average Pain During Movement
Day 14 following intervention
|
1.7 score on a scale
Standard Deviation 1.5
|
0 score on a scale
Standard Deviation 0
|
|
Average Pain During Movement
Day 30 following intervention
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Average Pain During Movement
Day 90 following intervention
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Daily for Days 1-14 following surgery, and then at 30 and 90 daysOxycodone consumption (oxycodone is a synthetic opioid). Both treatment groups are receiving active stimulation from 10 minutes following baseline until the leads are removed 2-4 weeks following baseline. However, we do not know if the order of the first 10 minutes of treatment (either sham then stimulation or stimulation then sham) affects subsequent effects. Therefore, these two treatment groups must remain separate for the remainder of the study period (even though both treatment groups are receiving the same intervention on each of the days described here).
Outcome measures
| Measure |
Electrical Current
n=4 Participants
electrical current will be introduced to the insulated percutaneous lead(s) for 5 minutes
Ultrasound-guided percutaneous peripheral nerve stimulation: Using ultrasound guidance, the small electrical lead is inserted adjacent to a target peripheral nerve through a percutaneously introduced 20-gauge needle. Following needle withdrawal, the percutaneous lead is attached to a miniature stimulator half the size of a business card that is simply adhered to the skin. When activated, the (active) stimulator generates a small electrical current which passes through the insulated leads to the uninsulated lead tip, which activates nerve fibers (placebo stimulators do not generate current).
|
Placebo
n=3 Participants
NO electrical current will be introduced to the insulated percutaneous lead(s) for 5 minutes
Ultrasound-guided percutaneous peripheral nerve stimulation: Using ultrasound guidance, the small electrical lead is inserted adjacent to a target peripheral nerve through a percutaneously introduced 20-gauge needle. Following needle withdrawal, the percutaneous lead is attached to a miniature stimulator half the size of a business card that is simply adhered to the skin. When activated, the (active) stimulator generates a small electrical current which passes through the insulated leads to the uninsulated lead tip, which activates nerve fibers (placebo stimulators do not generate current).
|
|---|---|---|
|
Opioid Consumption
Day 9 following intervention
|
8.3 mg
Standard Deviation 7.6
|
0 mg
Standard Deviation 0
|
|
Opioid Consumption
Day 10 following intervention
|
6.7 mg
Standard Deviation 7.6
|
0 mg
Standard Deviation 0
|
|
Opioid Consumption
Day 11 following intervention
|
8.3 mg
Standard Deviation 7.6
|
0 mg
Standard Deviation 0
|
|
Opioid Consumption
Day 1 following intervention
|
3.3 mg
Standard Deviation 5.8
|
0 mg
Standard Deviation 0
|
|
Opioid Consumption
Day 2 following intervention
|
10 mg
Standard Deviation 10
|
18.3 mg
Standard Deviation 27.5
|
|
Opioid Consumption
Day 3 following intervention
|
0 mg
Standard Deviation 0
|
13.3 mg
Standard Deviation 23.1
|
|
Opioid Consumption
Day 4 following intervention
|
1.7 mg
Standard Deviation 2.9
|
5.0 mg
Standard Deviation 8.7
|
|
Opioid Consumption
Day 5 following intervention
|
6.7 mg
Standard Deviation 11.5
|
3.3 mg
Standard Deviation 5.8
|
|
Opioid Consumption
Day 6 following intervention
|
5 mg
Standard Deviation 8.7
|
0 mg
Standard Deviation 0
|
|
Opioid Consumption
Day 7 following intervention
|
15 mg
Standard Deviation 15
|
0 mg
Standard Deviation 0
|
|
Opioid Consumption
Day 8 following intervention
|
15 mg
Standard Deviation 15
|
0 mg
Standard Deviation 0
|
|
Opioid Consumption
Day 12 following intervention
|
10 mg
Standard Deviation 10
|
0 mg
Standard Deviation 0
|
|
Opioid Consumption
Day 13 following intervention
|
8.3 mg
Standard Deviation 7.6
|
0 mg
Standard Deviation 0
|
|
Opioid Consumption
Day 14 following intervention
|
8.3 mg
Standard Deviation 7.6
|
0 mg
Standard Deviation 0
|
|
Opioid Consumption
Day 30 following intervention
|
0 mg
Standard Deviation 0
|
0 mg
Standard Deviation 0
|
|
Opioid Consumption
Day 90 following intervention
|
0 mg
Standard Deviation 0
|
0 mg
Standard Deviation 0
|
Adverse Events
Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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