Osteo Arthritis Knee
Conditions
Brief summary
The purpose of this study is to assess the feasibility, acceptability, and efficacy of self-administered transcranial direct current stimulation (tDCS) in older adults with knee osteoarthritis (OA)
Interventions
DEVICEActive tDCS
tDCS with a constant current intensity of 2 mA will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device (Soterix Medical Inc., NY) with headgear and saline-soaked surface sponge electrodes.
DEVICESham tDCS
For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds.
Sponsors
National Institute of Nursing Research (NINR)
Florida State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* have symptomatic knee OA based on American College of Rheumatology Clinical criteria * have had knee OA pain in the past 3 months with an average of at least 30 on a 0-100 NRS for pain * can speak and read English * have no plan to change medication regimens for pain throughout the trial
Exclusion criteria
* prosthetic knee replacement or nonarthroscopic surgery to the affected knee * history of brain surgery, brain tumor, seizure, stroke or intracranial metal implantation * systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia * alcohol/substance abuse * current use of sodium channel blockers, calcium channel blockers and NMDS receptor antagonists * diminished cognitive function that would interfere with understanding study procedures(i.e., Mini-Mental Status Exam score ≤ 23) * pregnancy or lactation * hospitalization within the preceding year for psychiatric illness * no access to a device with internet access that can be used for secure videoconferencing for real-time remote supervision
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Pain as Assessed by the Numeric Rating Scale (NRS) for Pain | baseline, week 3 | The Numeric Rating Scale (NRS) total score ranges from 0 (no pain) to 100 (most intense pain imaginable). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System | Baseline, week1, week2, and week 3 | 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. |
| Acceptability as Measured by the tDCs Experience Questionnaire | week 3 | 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. |
| Number of Participants With Possible Side Effects of Treatment | week 3 | 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. |
| Feasibility as Assessed by the Number of Participants That Complete the Full tDCS Protocol | week 3 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active tDCS 2mA current is applied for 20 minutes. | 60 |
| Sham tDCS 2mA current is applied for 30 seconds. | 60 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Active tDCS | Total | Sham tDCS |
|---|---|---|---|
| Age, Continuous | 65.32 years STANDARD_DEVIATION 8.41 | 65.96 years STANDARD_DEVIATION 8.407 | 66.60 years STANDARD_DEVIATION 8.43 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 11 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants | 109 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 8 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 41 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 33 Participants | 69 Participants | 36 Participants |
| Sex: Female, Male Female | 40 Participants | 82 Participants | 42 Participants |
| Sex: Female, Male Male | 20 Participants | 38 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 62 |
| other Total, other adverse events | 0 / 61 | 0 / 62 |
| serious Total, serious adverse events | 0 / 61 | 0 / 62 |
Outcome results
Primary
Change in Clinical Pain as Assessed by the Numeric Rating Scale (NRS) for Pain
The Numeric Rating Scale (NRS) total score ranges from 0 (no pain) to 100 (most intense pain imaginable).
Time frame: baseline, week 3
Population: Comparison of pain intensity changes between two groups at 3 weeks from baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS | Change in Clinical Pain as Assessed by the Numeric Rating Scale (NRS) for Pain | -24.07 score on a scale | Standard Deviation 21.55 |
| Sham tDCS | Change in Clinical Pain as Assessed by the Numeric Rating Scale (NRS) for Pain | -1.08 score on a scale | Standard Deviation 16.46 |
Secondary
Acceptability as Measured by the 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.
Time frame: week 3
Population: All participants completed tDCS experience questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS | Acceptability as Measured by the tDCs Experience Questionnaire | 62.93 score on a scale | Standard Deviation 8.48 |
| Sham tDCS | Acceptability as Measured by the tDCs Experience Questionnaire | 64.93 score on a scale | Standard Deviation 9.66 |
Secondary
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System
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.
Time frame: Baseline, week1, week2, and week 3
Population: All Subjects completed fNIRS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active tDCS | 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 |
| Active tDCS | 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 |
| Active tDCS | 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 |
| Active tDCS | 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 0.2 |
| Active tDCS | 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 |
| Active tDCS | 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 |
| Active tDCS | 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 |
| Active tDCS | 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 |
| Active tDCS | 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 |
| Active tDCS | 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 |
| Active tDCS | 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 |
| Active tDCS | 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 0.1 |
| Sham tDCS | 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 0.1 |
| Sham tDCS | 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 | 0.12 Pearson correlation coefficient | Standard Deviation 0.17 |
| Sham tDCS | 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 | 0.14 Pearson correlation coefficient | Standard Deviation 0.19 |
| Sham tDCS | Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System | Connectivity within Prefrontal cortex at baseline | 0.09 Pearson correlation coefficient | Standard Deviation 0.11 |
| Sham tDCS | 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 | 0.17 Pearson correlation coefficient | Standard Deviation 0.14 |
| Sham tDCS | 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 0.16 |
| Sham tDCS | 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 | 0.10 Pearson correlation coefficient | Standard Deviation 0.11 |
| Sham tDCS | 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 | 0.14 Pearson correlation coefficient | Standard Deviation 0.18 |
| Sham tDCS | 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 | -0.17 Pearson correlation coefficient | Standard Deviation 0.15 |
| Sham tDCS | 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 | 0.16 Pearson correlation coefficient | Standard Deviation 0.15 |
| Sham tDCS | 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 | -0.15 Pearson correlation coefficient | Standard Deviation 0.2 |
| Sham tDCS | 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 | -0.17 Pearson correlation coefficient | Standard Deviation 0.17 |
Secondary
Feasibility as Assessed by the Number of Participants That Complete the 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.
Time frame: week 3
Population: All participants completed full tDCS protocol.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active tDCS | Feasibility as Assessed by the Number of Participants That Complete the Full tDCS Protocol | 60 Participants |
| Sham tDCS | Feasibility as Assessed by the Number of Participants That Complete the Full tDCS Protocol | 60 Participants |
Secondary
Number of Participants With Possible Side Effects of Treatment
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.
Time frame: week 3
Population: Participants who experienced and reported any side effect.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active tDCS | Number of Participants With Possible Side Effects of Treatment | 0 Participants |
| Sham tDCS | Number of Participants With Possible Side Effects of Treatment | 0 Participants |