Trial Outcomes & Findings for Effects of tDCS and tUS on Pain Perception in OA of the Knee (NCT NCT02723929)
NCT ID: NCT02723929
Last Updated: 2025-09-29
Results Overview
Changes in the Visual Analogue Scale (VAS) for pain were measured in order to determine whether transcranial direct current stimulation in conjunction with transcranial ultrasound is effective in reducing pain in subjects with Osteoarthritis of the Knee. The VAS scale goes from 0 up to 10, where 0 means no pain at all and 10 means the worst imaginable pain and is reported following the full course of therapy. Since we are using a difference, smaller values (negative) represent a better outcome
Recruitment status
ACTIVE_NOT_RECRUITING
Target enrollment
64 participants
Primary outcome timeframe
Baseline and 8 weeks
Results posted on
2025-09-29
Participant Flow
64 subjects were enrolled and randomized
Participant milestones
| Measure |
Active Electrical Stim/Active Ultrasound
Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.
Active low-intensity transcranial electrical stimulation/active transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation. During active stimulation, the current will be active for the full 20 minutes.
Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for the full 20 minutes.
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Sham Electrical Stim/Sham Ultrasound
Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.
Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation, as in the active condition; however, during sham stimulation (placebo) the current will not be active for the full 20 minutes. Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes.
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|---|---|---|
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Overall Study
STARTED
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30
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34
|
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Overall Study
COMPLETED
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24
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24
|
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Overall Study
NOT COMPLETED
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6
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10
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of tDCS and tUS on Pain Perception in OA of the Knee
Baseline characteristics by cohort
| Measure |
Active Electrical Stim/Active Ultrasound
n=30 Participants
Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.
active low-intensity transcranial electrical stimulation/active transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation of up to 2mA. During active stimulation, the current will be active for the full 20 minutes.
Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for the full 20 minutes.
|
Sham Electrical Stim/Sham Ultrasound
n=34 Participants
Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.
Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation, as in the active condition; however, during sham stimulation (placebo) the current will not be active for the full 20 minutes.
Subjects will also undergo 20 minutes of transcranial ultrasound in the same par. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes.
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Total
n=64 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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61.4 years
STANDARD_DEVIATION 8.4 • n=5 Participants
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61.8 years
STANDARD_DEVIATION 8.7 • n=7 Participants
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61.6 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
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16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
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2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
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Region of Enrollment
United States
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30 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksChanges in the Visual Analogue Scale (VAS) for pain were measured in order to determine whether transcranial direct current stimulation in conjunction with transcranial ultrasound is effective in reducing pain in subjects with Osteoarthritis of the Knee. The VAS scale goes from 0 up to 10, where 0 means no pain at all and 10 means the worst imaginable pain and is reported following the full course of therapy. Since we are using a difference, smaller values (negative) represent a better outcome
Outcome measures
| Measure |
Active Electrical Stim/Active Ultrasound
n=30 Participants
Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.
Active low-intensity transcranial electrical stimulation/active transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation. During active stimulation, the current will be active for the full 20 minutes.
Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for the full 20 minutes.
|
Sham Electrical Stim/Sham Ultrasound
n=34 Participants
Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.
Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation, as in the active condition; however, during sham stimulation (placebo) the current will not be active for the full 20 minutes. Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes.
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|---|---|---|
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Changes in Pain Scale as Measured by VAS
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-2.21 units on a scale
Standard Error 0.2
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-1.6 units on a scale
Standard Error 0.1
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SECONDARY outcome
Timeframe: 8 weeksAnalgesic use (average daily dose of acetaminophen equivalent)
Outcome measures
| Measure |
Active Electrical Stim/Active Ultrasound
n=30 Participants
Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.
Active low-intensity transcranial electrical stimulation/active transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation. During active stimulation, the current will be active for the full 20 minutes.
Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for the full 20 minutes.
|
Sham Electrical Stim/Sham Ultrasound
n=34 Participants
Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.
Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation, as in the active condition; however, during sham stimulation (placebo) the current will not be active for the full 20 minutes. Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes.
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|---|---|---|
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Average Daily Dose of Acetaminophen Equivalent
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390.7 Acetaminophen equivalent in mg
Standard Error 47.1
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1116.4 Acetaminophen equivalent in mg
Standard Error 98.6
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SECONDARY outcome
Timeframe: Baseline and 4 weeks post-stimulationChanges in the Visual Analogue Scale (VAS) for pain were measured in order to determine whether transcranial direct current stimulation in conjunction with transcranial ultrasound is effective in reducing pain in subjects with Osteoarthritis of the Knee. The VAS scale goes from 0 up to 10, where 0 means no pain at all and 10 means the worst imaginable pain. Since we are using a difference, smaller values (negative) represent a better outcome.
Outcome measures
| Measure |
Active Electrical Stim/Active Ultrasound
n=30 Participants
Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.
Active low-intensity transcranial electrical stimulation/active transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation. During active stimulation, the current will be active for the full 20 minutes.
Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for the full 20 minutes.
|
Sham Electrical Stim/Sham Ultrasound
n=34 Participants
Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.
Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation, as in the active condition; however, during sham stimulation (placebo) the current will not be active for the full 20 minutes. Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes.
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|---|---|---|
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Changes in Pain Scale as Measured by VAS
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-2.91 units on a scale
Standard Error 0.38
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-1.28 units on a scale
Standard Error 0.30
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SECONDARY outcome
Timeframe: Baseline and 8 weeksThis measures the endogenous pain modulatory pathway. This study will evaluate DNIC in pain patients using pressure as the test stimulus, and cold water as the conditioning stimulus. DNIC will be induced approximately 1-min later by having subjects immerse their hand into a water bath maintained at 10-12˚C for approximately 1 min. Parallel to the last 30s of DNIC conditioning (cold water immersion), the pressure test stimulus will be reapplied. DNIC response will be calculated as the difference between the average of pain ratings from the test stimulus minus the average of pain ratings during the conditioned stimulus. Larger percentage change means a better outcome.
Outcome measures
| Measure |
Active Electrical Stim/Active Ultrasound
n=30 Participants
Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.
Active low-intensity transcranial electrical stimulation/active transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation. During active stimulation, the current will be active for the full 20 minutes.
Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for the full 20 minutes.
|
Sham Electrical Stim/Sham Ultrasound
n=34 Participants
Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.
Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation, as in the active condition; however, during sham stimulation (placebo) the current will not be active for the full 20 minutes. Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes.
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|---|---|---|
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Percentage Change in Diffuse Noxious Inhibitory Controls (DNIC) From Baseline
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12 Percentage change from baseline
Standard Error 2.9
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4.0 Percentage change from baseline
Standard Error 1.8
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SECONDARY outcome
Timeframe: Baseline and 8 weeksWe will record the time (seconds) for which a subject is able to stand unsupported on one foot while looking straight ahead with hands on hips. Larger percentage change means a better outcome.
Outcome measures
| Measure |
Active Electrical Stim/Active Ultrasound
n=30 Participants
Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.
Active low-intensity transcranial electrical stimulation/active transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation. During active stimulation, the current will be active for the full 20 minutes.
Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for the full 20 minutes.
|
Sham Electrical Stim/Sham Ultrasound
n=34 Participants
Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.
Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation, as in the active condition; however, during sham stimulation (placebo) the current will not be active for the full 20 minutes. Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes.
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|---|---|---|
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Percentage Change From Baseline in the Single Leg Standing Balance Test
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17.5 Percentage change from baseline
Standard Error 4.5
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3.0 Percentage change from baseline
Standard Error 3.1
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SECONDARY outcome
Timeframe: Baseline and 8 weeksThe subject was asked to stand unsupported with their feet parallel to each other in front of a step. We assessed the number of times the participant could place their foot up onto the step and return it to the floor over a 15-sec interval. Larger percentage change means a better outcome.
Outcome measures
| Measure |
Active Electrical Stim/Active Ultrasound
n=30 Participants
Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.
Active low-intensity transcranial electrical stimulation/active transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation. During active stimulation, the current will be active for the full 20 minutes.
Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for the full 20 minutes.
|
Sham Electrical Stim/Sham Ultrasound
n=34 Participants
Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.
Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation, as in the active condition; however, during sham stimulation (placebo) the current will not be active for the full 20 minutes. Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes.
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|---|---|---|
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Percentage Change From Baseline in the Step Test
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27.0 Percentage change from baseline
Standard Error 2.0
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18.7 Percentage change from baseline
Standard Error 1.8
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SECONDARY outcome
Timeframe: Baseline and 8 weeksSubject will be instructed to stand next to, but not touch the wall, and position the arm that is closer to the wall at 90 degrees of shoulder flexion with a closed fist. Smoothness of wrist movement is assessed as the subject was asked to outstretch their arm in a maximal forward reach, while maintaining a fixed base of support. Smoothness is dimensionless and is calculated as mean speed divided by peak speed. Larger percentage change means a better outcome.
Outcome measures
| Measure |
Active Electrical Stim/Active Ultrasound
n=30 Participants
Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.
Active low-intensity transcranial electrical stimulation/active transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation. During active stimulation, the current will be active for the full 20 minutes.
Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for the full 20 minutes.
|
Sham Electrical Stim/Sham Ultrasound
n=34 Participants
Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.
Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation, as in the active condition; however, during sham stimulation (placebo) the current will not be active for the full 20 minutes. Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes.
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|---|---|---|
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Percentage Change in Functional Reach Test From Baseline
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12.4 Percentage change from baseline
Standard Error 2.8
|
3.3 Percentage change from baseline
Standard Error 2.3
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Adverse Events
Active Electrical Stim/Active Ultrasound
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Sham Electrical Stim/Sham Ultrasound
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Electrical Stim/Active Ultrasound
n=30 participants at risk
Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.
active low-intensity transcranial electrical stimulation/active transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation. During active stimulation, the current will be active for the full 20 minutes.
Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for the full 20 minutes.
|
Sham Electrical Stim/Sham Ultrasound
n=34 participants at risk
Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.
Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound: Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation, as in the active condition; however, during sham stimulation (placebo) the current will not be active for the full 20 minutes.
Subjects will also undergo 20 minutes of transcranial ultrasound in the same par. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes.
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|---|---|---|
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Nervous system disorders
Tingling
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76.7%
23/30 • 2 months
Adverse effects were collected with a questionnaire for adverse effects
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85.3%
29/34 • 2 months
Adverse effects were collected with a questionnaire for adverse effects
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60