Trial Outcomes & Findings for Dose Dependent Effects of tDCS on Post-Operative Pain (NCT NCT02241967)
NCT ID: NCT02241967
Last Updated: 2022-07-13
Results Overview
Patient Controlled Analgesia pump usage will be measured (mg of morphine-equivalent) during the acute post-operative period.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
119 participants
Primary outcome timeframe
2-Days
Results posted on
2022-07-13
Participant Flow
Participant milestones
| Measure |
tDCS Full Dose
4 active treatments administered at 2mA for 20minutes each sessions, two the day of surgery and two the day after surgery.
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.
|
tDCS Half Dose
2 active treatments administered at 2mA for 20minutes each sessions. 2 real sessions the day of surgery and 2 sham sessions the day after surgery.
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.
|
tDCS Minimal Dose
1 active treatment administered at 2mA for 20minutes for the first session immediately following surgery, then 1 sham session later, day of surgery, and 2 sham sessions the day after surgery.
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.
|
Sham tDCS
no active treatments. All 4 sessions were sham tDCS. 2 delivered day of surgery, 2 delivered day after surgery.
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
29
|
|
Overall Study
COMPLETED
|
30
|
30
|
30
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose Dependent Effects of tDCS on Post-Operative Pain
Baseline characteristics by cohort
| Measure |
tDCS Full Dose
n=30 Participants
4 active treatments
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.
|
tDCS Half Dose
n=30 Participants
2 active treatments
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.
|
tDCS Minimal Dose
n=30 Participants
1 active treatment
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.
|
Sham tDCS
n=29 Participants
no active treatments
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 8.73 • n=5 Participants
|
67.0 years
STANDARD_DEVIATION 8.95 • n=7 Participants
|
63.5 years
STANDARD_DEVIATION 7.93 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 8.14 • n=4 Participants
|
64.7 years
STANDARD_DEVIATION 8.50 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
112 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
116 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
119 Participants
n=21 Participants
|
|
Procedure Type
Total Knee Arthroplasty (TKA)
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
|
Procedure Type
Total Hip Arthroplasty (THA)
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2-DaysPatient Controlled Analgesia pump usage will be measured (mg of morphine-equivalent) during the acute post-operative period.
Outcome measures
| Measure |
tDCS Full Dose
n=30 Participants
4 active treatments
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.
|
tDCS Half Dose
n=30 Participants
2 active treatments
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.
|
tDCS Minimal Dose
n=30 Participants
1 active treatment
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.
|
Sham tDCS
n=29 Participants
no active treatments
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.
|
|---|---|---|---|---|
|
Post-operative Opioid Pain Medication Dose
|
26.99 mg of morphine equivalent dose (MED)
Standard Error 2.99
|
31.12 mg of morphine equivalent dose (MED)
Standard Error 3.73
|
28.65 mg of morphine equivalent dose (MED)
Standard Error 31.12
|
33.15 mg of morphine equivalent dose (MED)
Standard Error 5.60
|
PRIMARY outcome
Timeframe: 2-DaysPatients reported pain intensity using a visual analog scale (VAS) before and after each tDCS session during the 2 day routine postoperative hospital stay. Patients reported pain intensity by marking a line anchored with a minimum of "0- no pain at all" to maximum of "10- worst pain imaginable." Lower values represent a more favorable outcome. This outcome data is the sum of all VAS scores collected before and after each tDCS session during the 2-day hospital stay, thus each participant had a total of 8 VAS scores during the experimental intervention during hospital stay.
Outcome measures
| Measure |
tDCS Full Dose
n=29 Participants
4 active treatments
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.
|
tDCS Half Dose
n=28 Participants
2 active treatments
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.
|
tDCS Minimal Dose
n=29 Participants
1 active treatment
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.
|
Sham tDCS
n=27 Participants
no active treatments
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.
|
|---|---|---|---|---|
|
Patient-reported Pain Intensity Ratings
|
5.33 score on a scale
Standard Error .44
|
5.59 score on a scale
Standard Error .43
|
5.84 score on a scale
Standard Error .48
|
5.33 score on a scale
Standard Error .56
|
SECONDARY outcome
Timeframe: 6 MonthsVisual analogue scale pain ratings will be collected during the perioperative and post-discharge periods . Visual analogue scale ratings range from 0-10; a blank line is anchored with a 0 and 10 with the following labels: "0- no pain," "10-worst pain imaginable."
Outcome measures
| Measure |
tDCS Full Dose
n=16 Participants
4 active treatments
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.
|
tDCS Half Dose
n=11 Participants
2 active treatments
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.
|
tDCS Minimal Dose
n=13 Participants
1 active treatment
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.
|
Sham tDCS
n=9 Participants
no active treatments
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.
|
|---|---|---|---|---|
|
Patient-reported Average Pain Ratings
|
3.06 score on a scale
Standard Error .46
|
3.45 score on a scale
Standard Error .72
|
3.77 score on a scale
Standard Error .74
|
4.89 score on a scale
Standard Error .59
|
Adverse Events
tDCS Full Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
tDCS Half Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
tDCS Minimal Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham tDCS
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
Jeffrey Borckardt, Ph.D
Ralph H. Johnson VA Medical Center
Phone: 843-792-3295
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place