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Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Analgesia

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ClinicalTrials.gov Identifier: NCT02898103
Recruitment Status : Completed
First Posted : September 13, 2016
Results First Posted : March 15, 2021
Last Update Posted : April 8, 2021
Sponsor:
Collaborators:
University California Academic Senate
Copenhagen University Hospital at Herlev
SPR Therapeutics
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Postoperative Pain
Interventions Device: Percutaneous peripheral nerve stimulation
Device: Sham stimulation
Enrollment 7
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Active Then Sham Then Active Sham Then Active Electrical Current
Hide Arm/Group Description 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 will be given for 5 minutes followed by active current for 2-4 weeks
Period Title: Overall Study
Started 4 3
Completed 4 3
Not Completed 0 0
Arm/Group Title Active Then Sham Then Active Sham Then Active Electrical Current Total
Hide Arm/Group Description 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 will be given for 5 minutes followed by active current for 2-4 weeks Total of all reporting groups
Overall Number of Baseline Participants 4 3 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 3 participants 7 participants
60.5  (3.9) 48.0  (20.8) 55  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
Female
4
 100.0%
2
  66.7%
6
  85.7%
Male
0
   0.0%
1
  33.3%
1
  14.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 3 participants 7 participants
4 3 7
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 4 participants 3 participants 7 participants
163.8  (3.3) 175.3  (19.8) 168.7  (13.2)
Height  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 4 participants 3 participants 7 participants
67.0  (10.9) 96.8  (40.2) 79.8  (29.2)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 4 participants 3 participants 7 participants
25.0  (3.8) 30.4  (5.2) 27.3  (5.0)
1.Primary Outcome
Title Change From Baseline of Surgical Site Pain Level (NRS) at Rest [Percentage of Baseline Pain]
Hide Description 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.
Time Frame 5 and 10 minutes after the stimulator is first activated
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Electrical Current Placebo
Hide Arm/Group Description:

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).

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).

Overall Number of Participants Analyzed 4 3
Mean (Full Range)
Unit of Measure: percentage of baseline
5 Minutes after baseline just before 1st intervention
64
(28 to 100)
100
(100 to 100)
10 minutes after baseline (which was just before 1st intervention)
55
(33 to 71)
69
(33 to 100)
2.Other Pre-specified Outcome
Title Percentage of Baseline Muscle Strength
Hide Description Strength 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.
Time Frame Two minutes following stimulation initiation following lead insertion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Electrical Current Placebo
Hide Arm/Group Description:
electrical current will be introduced to the insulated percutaneous lead for 5 minutes
NO electrical current will be introduced to the insulated percutaneous lead for 5 minutes
Overall Number of Participants Analyzed 4 3
Mean (Standard Deviation)
Unit of Measure: percentage of baseline muscle strength
1.0  (2.1) -2.3  (3.2)
3.Other Pre-specified Outcome
Title Worst Pain at Rest
Hide Description Pain 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).
Time Frame Daily for Days 1-14 following surgery, then at 30 and 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Then Sham Then Active Sham Then Active Electrical Current
Hide Arm/Group Description:
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 will be given for 5 minutes followed by active current for 2-4 weeks
Overall Number of Participants Analyzed 4 3
Mean (Standard Deviation)
Unit of Measure: score on a scale
Day 1 following intervention 1.7  (1.5) 0.7  (1.2)
Day 2 following intervention 2.7  (2.5) 3.0  (3.0)
Day 3 following intervention 1.3  (1.2) 1.0  (1.0)
Day 4 following intervention 0.7  (1.2) 0.7  (1.2)
Day 5 following intervention 1.3  (2.3) 1.3  (0.6)
Day 6 following intervention 1.3  (2.3) 1.0  (1.0)
Day 7 following intervention 2.7  (2.3) 0.3  (0.6)
Day 8 following intervention 3.0  (2.6) 0  (0)
Day 9 following intervention 2.3  (2.1) 0  (0)
Day 10 following intervention 2.3  (2.1) 0  (0)
Day 11 following intervention 3.3  (3.1) 0  (0)
Day 12 following intervention 3.0  (2.6) 0  (0)
Day 13 following intervention 2.3  (2.1) 0  (0)
Day 14 following intervention 2.5  (2.3) 0  (0)
Day 30 following intervention 0  (0) 0  (0)
Day 90 following intervention 0  (0) 0  (0)
4.Other Pre-specified Outcome
Title Average Pain at Rest
Hide Description Pain 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).
Time Frame Daily for days 1-14 following surgery, then at 30 and 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Then Sham Then Active Sham Then Active Electrical Current
Hide Arm/Group Description:
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 will be given for 5 minutes followed by active current for 2-4 weeks
Overall Number of Participants Analyzed 4 3
Mean (Standard Deviation)
Unit of Measure: score on a scale
Day 1 following intervention 0.5  (0.5) 0  (0)
Day 2 following intervention 1.3  (1.2) 0.7  (1.2)
Day 3 following intervention 1.3  (1.2) 0.3  (0.6)
Day 4 following intervention 0.3  (0.6) 0  (0)
Day 5 following intervention 0.3  (0.6) 0  (0)
Day 6 following intervention 0.3  (0.6) 0  (0)
Day 7 following intervention 0.3  (0.6) 0  (0)
Day 8 following intervention 0.3  (0.6) 0  (0)
Day 9 following intervention 1.0  (1.0) 0  (0)
Day 10 following intervention 1.0  (1.0) 0  (0)
Day 11 following intervention 1.3  (1.5) 0  (0)
Day 12 following intervention 1.0  (1.0) 0  (0)
Day 13 following intervention 1.0  (1.0) 0  (0)
Day 14 following intervention 1.0  (1.0) 0  (0)
Day 30 following intervention 0  (0) 0  (0)
Day 90 following intervention 0  (0) 0  (0)
5.Other Pre-specified Outcome
Title Worst Pain During Movement
Hide Description Pain 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).
Time Frame Daily for Days 1-14 following surgery, then at 30 and 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Then Sham Then Active Sham Then Active Electrical Current
Hide Arm/Group Description:
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 will be given for 5 minutes followed by active current for 2-4 weeks
Overall Number of Participants Analyzed 4 3
Mean (Standard Deviation)
Unit of Measure: score on a scale
Day 1 following intervention 2.7  (2.3) 0.7  (1.2)
Day 2 following intervention 4.2  (3.7) 2.7  (3.8)
Day 3 following intervention 3.0  (2.6) 1.0  (1.0)
Day 4 following intervention 2.0  (2.0) 0.7  (1.2)
Day 5 following intervention 2.0  (2.0) 1.3  (0.6)
Day 6 following intervention 2  (2) 1  (1)
Day 7 following intervention 2.7  (2.3) 0.3  (0.6)
Day 8 following intervention 3.3  (3.1) 0  (0)
Day 9 following intervention 2.7  (2.3) 0  (0)
Day 10 following intervention 3.0  (2.6) 0  (0)
Day 11 following intervention 3.7  (3.2) 0  (0)
Day 12 following intervention 3.3  (2.9) 0  (0)
Day 13 following intervention 3  (2.6) 0  (0)
Day 14 following intervention 3  (2.6) 0  (0)
Day 30 following intervention 0  (0) 0  (0)
Day 90 following intervention 0  (0) 0  (0)
6.Other Pre-specified Outcome
Title Average Pain During Movement
Hide Description Pain 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).
Time Frame Daily for Days 1-14 following surgery, and then at 30 and 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Then Sham Then Active Sham Then Active Electrical Current
Hide Arm/Group Description:
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 will be given for 5 minutes followed by active current for 2-4 weeks
Overall Number of Participants Analyzed 4 3
Mean (Standard Deviation)
Unit of Measure: score on a scale
Day 1 following intervention 1.2  (1.6) 0  (0)
Day 2 following intervention 2  (2) 0.7  (1.2)
Day 3 following intervention 2.3  (2.1) 0.7  (1.2)
Day 4 following intervention 1  (1) 0.3  (0.6)
Day 5 following intervention 1.2  (1.3) 0.3  (0.6)
Day 6 following intervention 0.7  (1.2) 0  (0)
Day 7 following intervention 1.8  (16) 0  (0)
Day 8 following intervention 1.7  (1.5) 0  (0)
Day 9 following intervention 1.7  (1.5) 0  (0)
Day 10 following intervention 1.7  (1.5) 0  (0)
Day 11 following intervention 1.8  (1.6) 0  (0)
Day 12 following intervention 2  (1.7) 0  (0)
Day 13 following intervention 1.3  (1.2) 0  (0)
Day 14 following intervention 1.7  (1.5) 0  (0)
Day 30 following intervention 0  (0) 0  (0)
Day 90 following intervention 0  (0) 0  (0)
7.Other Pre-specified Outcome
Title Opioid Consumption
Hide Description Oxycodone 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).
Time Frame Daily for Days 1-14 following surgery, and then at 30 and 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Then Sham Then Active Sham Then Active Electrical Current
Hide Arm/Group Description:
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 will be given for 5 minutes followed by active current for 2-4 weeks
Overall Number of Participants Analyzed 4 3
Mean (Standard Deviation)
Unit of Measure: mg
Day 1 following intervention 3.3  (5.8) 0  (0)
Day 2 following intervention 10  (10) 18.3  (27.5)
Day 3 following intervention 0  (0) 13.3  (23.1)
Day 4 following intervention 1.7  (2.9) 5.0  (8.7)
Day 5 following intervention 6.7  (11.5) 3.3  (5.8)
Day 6 following intervention 5  (8.7) 0  (0)
Day 7 following intervention 15  (15) 0  (0)
Day 8 following intervention 15  (15) 0  (0)
Day 9 following intervention 8.3  (7.6) 0  (0)
Day 10 following intervention 6.7  (7.6) 0  (0)
Day 11 following intervention 8.3  (7.6) 0  (0)
Day 12 following intervention 10  (10) 0  (0)
Day 13 following intervention 8.3  (7.6) 0  (0)
Day 14 following intervention 8.3  (7.6) 0  (0)
Day 30 following intervention 0  (0) 0  (0)
Day 90 following intervention 0  (0) 0  (0)
Time Frame 90 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stimulation Sham
Hide Arm/Group Description active electrical stimulation for 5 minutes followed by 5 minutes of sham and then 2-4 weeks of active electrical stimulation sham for 5 minutes followed by 5 minutes of active electrical stimulation and then 2-4 weeks of active electrical stimulation
All-Cause Mortality
Stimulation Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%) 
Hide Serious Adverse Events
Stimulation Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stimulation Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Brian Ilfeld, MD, MS
Organization: University California San Diego
Phone: 858-822-0776
EMail: bilfeld@ucsd.edu
Layout table for additonal information
Responsible Party: Brian M. Ilfeld, MD, MS, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02898103    
Other Study ID Numbers: Percutaneous PNS Postop pilot
First Submitted: September 2, 2016
First Posted: September 13, 2016
Results First Submitted: May 30, 2019
Results First Posted: March 15, 2021
Last Update Posted: April 8, 2021