Trial Outcomes & Findings for Transcranial Direct Current Stimulation in Older Persons With Knee Pain (Knee Pain and tDCS): Randomized Pilot Study (NCT NCT02512393)
NCT ID: NCT02512393
Last Updated: 2017-07-11
Results Overview
Numeric Rating Scale for pain is an 101-point scale for patient self-reporting of pain on a scale of 0 to 100, with 0 being no pain at all and 100 being the worst pain imaginable. The higher the score the worse the pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
baseline
Results posted on
2017-07-11
Participant Flow
Participant milestones
| Measure |
Active tDCS
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
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|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transcranial Direct Current Stimulation in Older Persons With Knee Pain (Knee Pain and tDCS): Randomized Pilot Study
Baseline characteristics by cohort
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
60.60 years
STANDARD_DEVIATION 9.80 • n=5 Participants
|
59.30 years
STANDARD_DEVIATION 8.60 • n=7 Participants
|
59.95 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baselineNumeric Rating Scale for pain is an 101-point scale for patient self-reporting of pain on a scale of 0 to 100, with 0 being no pain at all and 100 being the worst pain imaginable. The higher the score the worse the pain.
Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Numeric Rating Scale (NRS) for Pain
|
27.25 units on a scale
Standard Deviation 3.35
|
19.00 units on a scale
Standard Deviation 1.72
|
PRIMARY outcome
Timeframe: day 5Numeric Rating Scale for pain is an 101-point scale for patient self-reporting of pain on a scale of 0 to 100, with 0 being no pain at all and 100 being the worst pain imaginable. The higher the score the worse the pain.
Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Numeric Rating Scale (NRS) for Pain
|
8.75 units on a scale
Standard Deviation 1.54
|
12.55 units on a scale
Standard Deviation 2.98
|
PRIMARY outcome
Timeframe: baselineThis is a index to rate the activity of pain, stiffness, and physical function based on a scale of difficulty: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme; subscales are added up for a summation score. The higher the score, the worse the pain.
Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale
|
29.30 units on a scale
Standard Deviation 3.68
|
20.40 units on a scale
Standard Deviation 2.13
|
PRIMARY outcome
Timeframe: day 5This is a index to rate the activity of pain, stiffness, and physical function based on a scale of difficulty: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme; subscales are added up for a summation score. The higher the score, the worse the pain.
Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale
|
24.20 units on a scale
Standard Deviation 2.57
|
19.50 units on a scale
Standard Deviation 2.93
|
PRIMARY outcome
Timeframe: baselineThis is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.
Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale
|
2.25 units on a scale
Standard Deviation 0.48
|
1.50 units on a scale
Standard Deviation 0.23
|
PRIMARY outcome
Timeframe: day 5This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.
Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale
|
1.29 units on a scale
Standard Deviation 0.22
|
1.60 units on a scale
Standard Deviation 0.41
|
PRIMARY outcome
Timeframe: baselineThis is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.
Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale
|
1.75 units on a scale
Standard Deviation 0.58
|
0.98 units on a scale
Standard Deviation 0.28
|
PRIMARY outcome
Timeframe: day 5This is a index to rate the activity of pain based on a scale of difficulty: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme. The higher the score, the worse the pain.
Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale
|
0.96 units on a scale
Standard Deviation 0.33
|
1.15 units on a scale
Standard Deviation 0.39
|
PRIMARY outcome
Timeframe: baselineThis is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.
Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale
|
0.93 units on a scale
Standard Deviation 0.29
|
0.80 units on a scale
Standard Deviation 0.20
|
PRIMARY outcome
Timeframe: day 5This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.
Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale
|
0.54 units on a scale
Standard Deviation 0.13
|
0.66 units on a scale
Standard Deviation 0.20
|
PRIMARY outcome
Timeframe: baselineThis is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.
Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
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|---|---|---|
|
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale
|
1.58 units on a scale
Standard Deviation 0.51
|
0.66 units on a scale
Standard Deviation 0.20
|
PRIMARY outcome
Timeframe: day 5This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.
Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale
|
0.61 units on a scale
Standard Deviation 0.15
|
0.77 units on a scale
Standard Deviation 0.21
|
PRIMARY outcome
Timeframe: baselineThe six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The lower the score the worse the condition.
Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Six-minute Walk Test
|
478.18 meters
Standard Deviation 16.46
|
490.71 meters
Standard Deviation 18.26
|
PRIMARY outcome
Timeframe: day 5The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The lower the score the worse the condition.
Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Six-minute Walk Test
|
497.47 meters
Standard Deviation 16.75
|
494.26 meters
Standard Deviation 18.77
|
PRIMARY outcome
Timeframe: baselineThis is a group of measures that combines the results of the gait speed, chair stand, and balance tests. The score ranges from 0 (worst performance) to 12 (best performance).
Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Short Physical Performance Battery (SPPB)
|
11.05 units on a scale
Standard Deviation 0.27
|
11.10 units on a scale
Standard Deviation 0.33
|
PRIMARY outcome
Timeframe: day 5This is a group of measures that combines the results of the gait speed, chair stand, and balance tests. The score ranges from 0 (worst performance) to 12 (best performance).
Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Short Physical Performance Battery (SPPB)
|
11.25 units on a scale
Standard Deviation 0.28
|
11.05 units on a scale
Standard Deviation 0.33
|
PRIMARY outcome
Timeframe: baselineQuantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.
Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Heat Pain Threshold
|
41.84 Celsius
Standard Deviation 4.38
|
40.51 Celsius
Standard Deviation 4.69
|
PRIMARY outcome
Timeframe: day 5Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.
Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Heat Pain Threshold
|
42.62 Celsius
Standard Deviation 3.20
|
40.18 Celsius
Standard Deviation 4.34
|
PRIMARY outcome
Timeframe: baselineQuantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.
Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Heat Pain Tolerance
|
46.47 Celsius
Standard Deviation 3.01
|
45.04 Celsius
Standard Deviation 3.59
|
PRIMARY outcome
Timeframe: day 5Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.
Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Heat Pain Tolerance
|
47.07 Celsius
Standard Deviation 2.26
|
45.42 Celsius
Standard Deviation 3.50
|
PRIMARY outcome
Timeframe: baselineQuantitative Sensory Testing (QST) by using pressure pain delivered by a hand-held algometer.
Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Pressure Pain Threshold
|
2.61 kilopascal (kPa)
Standard Deviation 1.13
|
2.63 kilopascal (kPa)
Standard Deviation 1.30
|
PRIMARY outcome
Timeframe: day 5Quantitative Sensory Testing (QST) by using pressure pain delivered by a hand-held algometer.
Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Pressure Pain Threshold
|
3.21 kilopascal (kPa)
Standard Deviation 1.08
|
2.98 kilopascal (kPa)
Standard Deviation 1.10
|
PRIMARY outcome
Timeframe: baselineQuantitative Sensory Testing (QST) by using punctate mechanical pain delivered by a calibrated nylon monofilament.
Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Punctate Mechanical Pain Sensitivity
|
45.85 kilopascal (kPa)
Standard Deviation 31.94
|
46.60 kilopascal (kPa)
Standard Deviation 25.99
|
PRIMARY outcome
Timeframe: day 5Quantitative Sensory Testing (QST) by using punctate mechanical pain delivered by a calibrated nylon monofilament.
Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Punctate Mechanical Pain Sensitivity
|
42.23 kilopascal (kPa)
Standard Deviation 26.87
|
50.73 kilopascal (kPa)
Standard Deviation 33.61
|
PRIMARY outcome
Timeframe: baselineConditioned pain modulation (CPM) will be done by using a cold pressor procedure on the skin. The measure is scored on a scale, which ranges from zero to infinity. A higher CPM score indicates higher pain inhibition.
Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Conditioned Pain Modulation (CPM)
|
0.84 units on a scale
Standard Deviation 0.69
|
0.73 units on a scale
Standard Deviation 0.48
|
PRIMARY outcome
Timeframe: day 5Conditioned pain modulation (CPM) will be done by using a cold pressor procedure on the skin. The measure is scored on a scale, which ranges from zero to infinity. A higher CPM score indicates higher pain inhibition.
Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Conditioned Pain Modulation (CPM)
|
0.94 units on a scale
Standard Deviation 0.52
|
0.70 units on a scale
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: baselineOutcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Endorphin Level
|
0.04 ng/mL
Standard Deviation 0.01
|
0.04 ng/mL
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: day 5Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Endorphin Level
|
0.04 ng/mL
Standard Deviation 0.02
|
0.05 ng/mL
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: baselineOutcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Cortisol Level
|
47085.48 pg/mL
Standard Deviation 36657.95
|
39358.75 pg/mL
Standard Deviation 29387.62
|
SECONDARY outcome
Timeframe: day 5Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Cortisol Level
|
46588.50 pg/mL
Standard Deviation 32249.18
|
38853.23 pg/mL
Standard Deviation 24343.37
|
SECONDARY outcome
Timeframe: baselineOutcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
C-reactive Protein (CRP) Level
|
1394.33 ng/mL
Standard Deviation 1278.41
|
1758.26 ng/mL
Standard Deviation 2833.17
|
SECONDARY outcome
Timeframe: day 5Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
C-reactive Protein (CRP) Level
|
1496.74 ng/mL
Standard Deviation 1469.79
|
3372.98 ng/mL
Standard Deviation 5490.50
|
SECONDARY outcome
Timeframe: baselineOutcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Tumor Necrosis Factor (TNF) Level
|
7.63 pg/mL
Standard Deviation 3.42
|
10.20 pg/mL
Standard Deviation 5.78
|
SECONDARY outcome
Timeframe: day 5Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Tumor Necrosis Factor (TNF) Level
|
7.41 pg/mL
Standard Deviation 3.27
|
10.36 pg/mL
Standard Deviation 5.98
|
SECONDARY outcome
Timeframe: baselineOutcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Interleukin 6 (IL-6) Level
|
2.12 pg/mL
Standard Deviation 1.78
|
3.57 pg/mL
Standard Deviation 3.65
|
SECONDARY outcome
Timeframe: day 5Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Interleukin 6 (IL-6) Level
|
2.40 pg/mL
Standard Deviation 1.43
|
3.37 pg/mL
Standard Deviation 2.62
|
SECONDARY outcome
Timeframe: baselineOutcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Interleukin 10 (IL-10) Level
|
6.25 pg/mL
Standard Deviation 3.20
|
8.91 pg/mL
Standard Deviation 5.36
|
SECONDARY outcome
Timeframe: day 5Outcome measures
| Measure |
Active tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
Sham tDCS
n=20 Participants
This group will receive five daily sessions of 2mA, current for 30 seconds tDCS. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
|
|---|---|---|
|
Interleukin 10 (IL-10) Level
|
5.68 pg/mL
Standard Deviation 2.85
|
8.17 pg/mL
Standard Deviation 4.56
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline and day 5A score of 50 is the average and a score of 60 is better than average. A score of 40 is the worse score.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline, 1, 2, 3, 4, and 5 daysThis is a questionnaire to assess the presence and severity of adverse events such as headache, tingling, itching, and fatigue, on a scale of 0 to 10, with 0 being not at all and 10 being a highest degree.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline and day 5This is a questionnaire to assess pain coping strategies, such as distancing from pain, using a 7-point scale that ranges from never do that to always do that. The higher the scale the greater use.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline and day 5This is a questionnaire using a 5-point scale that ranges from very slightly or not at all to extremely. The lower the scale the negative the affect and the higher the scare the positive the affect.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline and day 5This is a questionnaire to assess pain attitudes, such as stoicism, using a 5-point scale that ranges from strongly disagree to strongly agree. The higher the scale the more stoic.
Outcome measures
Outcome data not reported
Adverse Events
Active tDCS
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
Hyochol Ahn, PhD, ARNP
The University of Texas Health Science Center at Houston
Phone: 713-500-2179
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place