Trial Outcomes & Findings for Evaluation of the Effectiveness of tDCS in the Management of Perioperative Pain (NCT NCT01861587)
NCT ID: NCT01861587
Last Updated: 2018-08-07
Results Overview
The PCA pump usage was downloaded from the PCA pump after discharge from the hospital.
COMPLETED
NA
27 participants
Participants were followed for the duration of hospital stay, an average of 48 hours.
2018-08-07
Participant Flow
Participant milestones
| Measure |
Real tDCS:Active Comparator
For Real tDCS, stimulation will be delivered in 20-minute-sessions using 2mA current. The anode will be placed over left BA9 or the motor cortex corresponding with the painful area (if applicable). The cathode will be placed over right BA43 (for GI pain) or right BA9 (located via the international 10-20 EEG system).
|
Sham tDCS: Sham Comparator
For sham tDCS, the device will be turned on for 30 seconds and then turned off for the duration of the 20-minute session.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
|
Overall Study
COMPLETED
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Effectiveness of tDCS in the Management of Perioperative Pain
Baseline characteristics by cohort
| Measure |
Real tDCS:Active Comparator
n=14 Participants
tDCS: 20 minutes of either real or sham stimulation
|
Sham tDCS: Sham Comparator
n=13 Participants
tDCS: 20 minutes of either real or sham stimulation
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.4 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
59.4 years
STANDARD_DEVIATION 2.1 • n=7 Participants
|
59.4 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants were followed for the duration of hospital stay, an average of 48 hours.The PCA pump usage was downloaded from the PCA pump after discharge from the hospital.
Outcome measures
| Measure |
Real tDCS:Active Comparator
n=14 Participants
tDCS: 20 minutes of stimulation at 2mA.
|
Sham tDCS: Sham Comparator
n=13 Participants
For Sham tDCS, the stimulator was turned off automatically after 45 seconds.
|
|---|---|---|
|
Patient Controlled Analgesia (PCA) Hydromorphone Usage
|
12.6 milligrams of hydromorphone
Standard Deviation 9.9
|
16.5 milligrams of hydromorphone
Standard Deviation 12.7
|
PRIMARY outcome
Timeframe: Baseline and DischargeTo assess each participant's average pain at it's least in the past 24 hours, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain at it's least in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.
Outcome measures
| Measure |
Real tDCS:Active Comparator
n=14 Participants
tDCS: 20 minutes of stimulation at 2mA.
|
Sham tDCS: Sham Comparator
n=13 Participants
For Sham tDCS, the stimulator was turned off automatically after 45 seconds.
|
|---|---|---|
|
Average Pain at Least
Baseline
|
4.5 units on a scale
Standard Deviation 2.5
|
3.5 units on a scale
Standard Deviation 1.6
|
|
Average Pain at Least
Discharge
|
3.2 units on a scale
Standard Deviation 2.2
|
3.5 units on a scale
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: Baseline OnlyTo assess each participant's average pain at it's worst in the past 24 hours at Baseline, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain at it's worst in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.
Outcome measures
| Measure |
Real tDCS:Active Comparator
n=14 Participants
tDCS: 20 minutes of stimulation at 2mA.
|
Sham tDCS: Sham Comparator
n=13 Participants
For Sham tDCS, the stimulator was turned off automatically after 45 seconds.
|
|---|---|---|
|
Average Pain at Worst
|
8.9 units on a scale
Standard Deviation 1.2
|
8.0 units on a scale
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: Baseline OnlyTo assess each participant's pain on average in the past 24 hours at Baseline, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their pain on average in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.
Outcome measures
| Measure |
Real tDCS:Active Comparator
n=14 Participants
tDCS: 20 minutes of stimulation at 2mA.
|
Sham tDCS: Sham Comparator
n=13 Participants
For Sham tDCS, the stimulator was turned off automatically after 45 seconds.
|
|---|---|---|
|
Average Pain
|
7.0 units on a scale
Standard Deviation 1.5
|
6.3 units on a scale
Standard Deviation 1.4
|
Adverse Events
Real tDCS:Active Comparator
Sham tDCS: Sham Comparator
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jeffrey Borckardt, Ph.D
Medical University of South Carolina
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place