Trial Outcomes & Findings for Self-Administered Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis (NCT NCT04016272)
NCT ID: NCT04016272
Last Updated: 2023-05-10
Results Overview
The Numeric Rating Scale (NRS) total score ranges from 0 (no pain) to 100 (most intense pain imaginable).
COMPLETED
NA
123 participants
baseline, week 3
2023-05-10
Participant Flow
Participant milestones
| Measure |
Active tDCS
tDCS with a constant current intensity of 2 mA was applied for 20 minutes five times a week (Monday to Friday) for 3 weeks via the Soterix 1 × 1 tDCS mini-CT Stimulator device (Soterix Medical Inc., New York, NY, USA; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5 × 7 cm sponge electrodes.
|
Sham tDCS
tDCS with a constant current intensity of 2 mA was applied for 30 seconds out of 20 minutes five times a week (Monday to Friday) for 3 weeks via the Soterix 1 × 1 tDCS mini-CT Stimulator device (Soterix Medical Inc., New York, NY, USA; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5 × 7 cm sponge electrodes.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
62
|
|
Overall Study
COMPLETED
|
60
|
60
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Active tDCS
tDCS with a constant current intensity of 2 mA was applied for 20 minutes five times a week (Monday to Friday) for 3 weeks via the Soterix 1 × 1 tDCS mini-CT Stimulator device (Soterix Medical Inc., New York, NY, USA; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5 × 7 cm sponge electrodes.
|
Sham tDCS
tDCS with a constant current intensity of 2 mA was applied for 30 seconds out of 20 minutes five times a week (Monday to Friday) for 3 weeks via the Soterix 1 × 1 tDCS mini-CT Stimulator device (Soterix Medical Inc., New York, NY, USA; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5 × 7 cm sponge electrodes.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Self-Administered Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
Active tDCS
n=60 Participants
2mA current is applied for 20 minutes.
|
Sham tDCS
n=60 Participants
2mA current is applied for 30 seconds.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.32 years
STANDARD_DEVIATION 8.41 • n=5 Participants
|
66.60 years
STANDARD_DEVIATION 8.43 • n=7 Participants
|
65.96 years
STANDARD_DEVIATION 8.407 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 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
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
69 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
|
PRIMARY outcome
Timeframe: baseline, week 3Population: Comparison of pain intensity changes between two groups at 3 weeks from baseline.
The Numeric Rating Scale (NRS) total score ranges from 0 (no pain) to 100 (most intense pain imaginable).
Outcome measures
| Measure |
Active tDCS
n=60 Participants
2mA current is applied for 20 minutes.
|
Sham tDCS
n=60 Participants
2mA current is applied for 30 seconds.
|
|---|---|---|
|
Change in Clinical Pain as Assessed by the Numeric Rating Scale (NRS) for Pain
|
-24.07 score on a scale
Standard Deviation 21.55
|
-1.08 score on a scale
Standard Deviation 16.46
|
SECONDARY outcome
Timeframe: Baseline, week1, week2, and week 3Population: All Subjects completed fNIRS.
Pain-related cortical response will be measured using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) with three semiconductor lasers at 780, 805, and 830 nm. Optical recordings will be collected during thermal and punctate pain stimulation and correlation values will be presented in the form of figures. * Specify the full scale: Pearson correlation coefficient (r) between pairs of brain regions (fNIRS channels). * A value of r=0 indicates that two brain regions were functionally disconnected. * Greater absolute r values denote stronger connections. However, this does not indicate a better or worse result but only a different type of connectivity on a macroscale (when considering several fNIRS channels). * We used \|r\|\>0.3 (absolute value of r greater than 0.3) to extract meaningful functional connections.
Outcome measures
| Measure |
Active tDCS
n=61 Participants
2mA current is applied for 20 minutes.
|
Sham tDCS
n=62 Participants
2mA current is applied for 30 seconds.
|
|---|---|---|
|
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System
Connectivity between PFC and M1_S1 cortices at week 2
|
-0.14 Pearson correlation coefficient
Standard Deviation 0.13
|
-0.15 Pearson correlation coefficient
Standard Deviation 0.20
|
|
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System
Connectivity within Primary motor-somatosensory cortices at baseline
|
0.18 Pearson correlation coefficient
Standard Deviation 0.21
|
0.12 Pearson correlation coefficient
Standard Deviation 0.17
|
|
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System
Connectivity within Prefrontal cortex at baseline
|
0.10 Pearson correlation coefficient
Standard Deviation 0.12
|
0.09 Pearson correlation coefficient
Standard Deviation 0.11
|
|
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System
Connectivity between PFC and M1_S1 cortices at baseline
|
-0.12 Pearson correlation coefficient
Standard Deviation 0.17
|
-0.12 Pearson correlation coefficient
Standard Deviation 0.16
|
|
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System
Connectivity within Primary motor-somatosensory cortices at week 1
|
0.17 Pearson correlation coefficient
Standard Deviation 0.20
|
0.14 Pearson correlation coefficient
Standard Deviation 0.18
|
|
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System
Connectivity within Prefrontal cortex at week 1
|
0.09 Pearson correlation coefficient
Standard Deviation 0.13
|
0.16 Pearson correlation coefficient
Standard Deviation 0.15
|
|
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System
Connectivity between PFC and M1_S1 cortices at week 1
|
-0.13 Pearson correlation coefficient
Standard Deviation 0.12
|
-0.17 Pearson correlation coefficient
Standard Deviation 0.17
|
|
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System
Connectivity within Primary motor-somatosensory cortices at week 2
|
0.17 Pearson correlation coefficient
Standard Deviation 0.17
|
0.14 Pearson correlation coefficient
Standard Deviation 0.19
|
|
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System
Connectivity within Prefrontal cortex at week 2
|
0.09 Pearson correlation coefficient
Standard Deviation 0.09
|
0.10 Pearson correlation coefficient
Standard Deviation 0.11
|
|
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System
Connectivity within Primary motor-somatosensory cortices at week 3
|
0.18 Pearson correlation coefficient
Standard Deviation 0.14
|
0.17 Pearson correlation coefficient
Standard Deviation 0.14
|
|
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System
Connectivity within Prefrontal cortex at week 3
|
0.10 Pearson correlation coefficient
Standard Deviation 0.11
|
0.10 Pearson correlation coefficient
Standard Deviation 0.10
|
|
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System
Connectivity between PFC and M1_S1 cortices at week 3
|
-0.14 Pearson correlation coefficient
Standard Deviation 0.10
|
-0.17 Pearson correlation coefficient
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: week 3Population: All participants completed tDCS experience questionnaire.
The tDCS experience questionnaire contains 10 questions based on a scale from 0-10, 0 being strongly disagree and 10 being strongly agree. Higher scores indicating greater acceptability for 7 questions and lower scores indicating greater acceptability for 3 questions resulting most desirable score of a 70.
Outcome measures
| Measure |
Active tDCS
n=60 Participants
2mA current is applied for 20 minutes.
|
Sham tDCS
n=60 Participants
2mA current is applied for 30 seconds.
|
|---|---|---|
|
Acceptability as Measured by the tDCs Experience Questionnaire
|
62.93 score on a scale
Standard Deviation 8.48
|
64.93 score on a scale
Standard Deviation 9.66
|
SECONDARY outcome
Timeframe: week 3Population: Participants who experienced and reported any side effect.
If any side effects are reported, the degree of relatedness to the intervention will be assessed on a 10-point scale, from 0 (not at all) to 10 (to a high degree). The questionnaire ask to what extend did the participant experienced symptoms like, tingling, itching sensation, burning sensation, pain at the stimulation site, fatigue, nervousness, headache, difficulty concentrating, or mood change.
Outcome measures
| Measure |
Active tDCS
n=60 Participants
2mA current is applied for 20 minutes.
|
Sham tDCS
n=60 Participants
2mA current is applied for 30 seconds.
|
|---|---|---|
|
Number of Participants With Possible Side Effects of Treatment
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: week 3Population: All participants completed full tDCS protocol.
We will calculate the percentage of participants who a) meet the inclusion criteria, b) agree to be randomly assigned, c) complete the full tDCS protocol, and d) attend the follow-up assessment.
Outcome measures
| Measure |
Active tDCS
n=60 Participants
2mA current is applied for 20 minutes.
|
Sham tDCS
n=60 Participants
2mA current is applied for 30 seconds.
|
|---|---|---|
|
Feasibility as Assessed by the Number of Participants That Complete the Full tDCS Protocol
|
60 Participants
|
60 Participants
|
Adverse Events
Active tDCS
Sham tDCS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place