Chronic Pain, Knee Osteoarthritis
Conditions
Keywords
Knee Osteoarthritis, Chronic Pain, Osteoarthritis, Transcranial Direct Current Stimulation, tDCS
Brief summary
The purpose of this study is to determine the feasibility and preliminary efficacy of two weeks of self Transcranial Direct Current Stimulation (tDCS) for pain in older patients with knee osteoarthritis (OA).
Interventions
Transcranial Direct Current Stimulation (tDCS) involves the application of weak direct electric current to the head in a noninvasive and painless manner. 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. Participants will self-administer tDCS at their home or a private room for two weeks (Mondays-Fridays) under real-time supervision by the research staff.
Sponsors
Study design
Eligibility
Inclusion criteria
* have self-reported unilateral or bilateral knee OA pain, according to American College of Rheumatology criteria * have had knee OA pain in the past 3 months with an average of at least 3 on a 10 cm Visual Analog Scale (VAS) for pain * can speak and read English * have a device with internet access that can be used for secure video conferencing for real-time remote supervision * have access to a distraction-free, well lit, clean environment with a safe area to store the device and device kit * have no plan to change medication regimens for pain throughout the trial * are able to travel to the coordinating center * are willing and able to provide written informed consent prior to enrollment.
Exclusion criteria
* previous prosthetic knee replacement or non-arthroscopic surgery to the affected knee * history of brain surgery, tumor, seizure, stroke, or intracranial metal implantation * systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia * uncontrolled hypertension (i.e., systolic blood pressure/ diastolic blood pressure ≥ 150/95 mm Hg) * heart failure * history of acute myocardial infarction * peripheral neuropathy * alcohol/substance abuse * cognitive impairment (i.e., Mini-Mental Status Exam score ≤ 23) * pregnancy or lactation * hospitalization within the preceding year for psychiatric illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Pain Intensity as Assessed by a Visual Analogue Scale (VAS) | baseline | Scores on the visual analogue scale (VAS) range from 0 (no pain) to 100 (worst pain imaginable). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Stiffness Subscale | baseline | The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively. |
| Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Functional Impairment Subscale | baseline | The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively. |
| Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Continuous Pain Summary Scale | baseline | The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = none to 10 = worst possible). The continuous pain subscale assesses throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender, and total score on the continuous pain subscale ranges from 0-60, with a higher score indicating worse pain. |
| Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Continuous Pain Subscale | 2 weeks | The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = none to 10 = worst possible). The continuous pain subscale assesses throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender, and total score on the continuous pain subscale ranges from 0-60, with a higher score indicating worse pain. |
| Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Intermittent Pain Subscale | baseline | The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = none to 10 = worst possible). The intermittent pain subscale assesses shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing, and total score on the intermittent pain subscale ranges from 0-60, with a higher score indicating worse pain. |
| Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Neuropathic Pain Subscale | baseline | The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = none to 10 = worst possible). The neuropathic pain subscale assesses hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or 'pins and needles', and numbness, and total score on the neuropathic pain subscale ranges from 0-60, with a higher score indicating worse pain. |
| Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Affective Description Subscale | baseline | The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = none to 10 = worst possible). The affective description subscale assesses tiring-exhausting, sickening, fearful, and punishing-cruel, and total score on the affective description subscale ranges from 0-40, with a higher score indicating worse pain. |
| Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Threshold (HPTH) | baseline | In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess HPTH, heat stimuli were delivered to the participant's arm or knee using a computer-controlled TSAII NeuroSensory Analyzer. From a baseline of 32 degrees Celsius, the temperature increased by 0.5 degrees Celsius per second until the participants responded by pressing a button to stop heat stimuli. Participants were instructed to press the button when the sensation ''first becomes painful to assess the heat pain threshold (HPTH). The temperature at which participants pressed the button to indicate the sensation ''first becomes painful is reported. |
| Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Tolerance (HPTO) | baseline | In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess HPTO, heat stimuli were delivered to the participant's arm or knee using a computer-controlled TSAII NeuroSensory Analyzer. From a baseline of 32 degrees Celsius, the temperature increased by 0.5 degrees Celsius per second until the participants responded by pressing a button to stop heat stimuli. Participants were instructed to press the button when they ''no longer feel able to tolerate the pain. The temperature at which participants pressed the button to indicate they could ''no longer feel able to tolerate the pain is reported. |
| Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT) | baseline | In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm\^2) per second to the participant's medial knee, lateral knee, or trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful. The pressure at which participants pressed the button to indicate that the pressure sensation ''first becomes painful is reported. |
| Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Subscale | baseline | The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively. |
| Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM) | baseline | In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). CPM is reported as the change in PPT before and immediately following immersion of the contralateral hand up to the wrist in a cold water bath (12 degrees Celsius) for up to one minute. To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm\^2) per second to the participant's trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful. The pressure at which participants pressed the button to indicate that the pressure sensation ''first becomes painful is reported. |
| Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy (fNIRS) | 2 weeks | 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 pain stimulation. |
| Feasibility as Assessed by a Survey of Participants' tDCS Experience - Ease of Using Device | 2 weeks | Data will be collected on participants' tDCS experience at the conclusion of tDCS treatment on a scale of 0 (strongly disagree) to 10 (strongly agree): Q1) Overall the device was easy to use |
| Feasibility as Assessed by a Survey of Participants' tDCS Experience - Ease of Preparation of Device | 2 weeks | Data will be collected on participants' tDCS experience at the conclusion of tDCS treatment on a scale of 0 (strongly disagree) to 10 (strongly agree): Q2) It was easy to prepare the device and accessories |
| Feasibility as Assessed by a Survey of Participants' tDCS Experience - Effectiveness of Treatment Over Time | 2 weeks | Data will be collected on participants' tDCS experience at the conclusion of tDCS treatment on a scale of 0 (strongly disagree) to 10 (strongly agree): Q3) The effectiveness of the treatment increased over the course of treatment. |
| Tolerability as Assessed by Number of Participants With Side Effects | 2 weeks | The participants will be asked in an open-ended manner whether they have experienced any side effects, and they will then be asked specifically about tingling, itching sensation, burning sensation, pain at the stimulation site, fatigue, nervousness, headache, difficulty concentrating, mood change, and changes in vision or visual perception. |
| Anxiety as Assessed by the PROMIS Anxiety-short Form | baseline | The 7-item PROMIS anxiety-short form assesses the pure domain of anxiety in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety. |
| Depression as Assessed by the PROMIS Depression-short Form | baseline | The 8-item PROMIS depression-short form assesses the pure domain of depression in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression. |
| Sleep Disturbance as Assessed by the PROMIS Sleep Disturbance-short Form | baseline | The 8-item PROMIS sleep disturbance-short form assesses the pure domain of sleep disturbance in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance. |
| Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Punctate Mechanical Pain (PMP) | baseline | In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess PMP, punctate mechanical pain is delivered to the patella or hand by a calibrated nylon monofilament for 10 contacts of the monofilament at one contact per second. Participants rate the pain intensity on a scale from 0 (no pain) to 100 (maximum imaginable pain). |
Countries
United States
Participant flow
Pre-assignment details
1 participant withdrew before the intervention started.
Participants by arm
| Arm | Count |
|---|---|
| Transcranial Direct Current Stimulation Transcranial Direct Current Stimulation (tDCS) involves the application of weak direct electric current to the head in a noninvasive and painless manner. 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. Participants will self-administer tDCS at their home or a private room for two weeks (Mondays-Fridays) under real-time supervision by the research staff. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Transcranial Direct Current Stimulation |
|---|---|
| Age, Continuous | 61.2 years STANDARD_DEVIATION 7.23 |
| Body Mass Index (BMI) | 28.33 kg/m^2 STANDARD_DEVIATION 8.01 |
| Education 2-year college | 5 Participants |
| Education 4-year college | 9 Participants |
| Education Doctoral degree | 1 Participants |
| Education High School | 3 Participants |
| Education Master's degree | 2 Participants |
| Osteoarthritis duration | 29.60 months STANDARD_DEVIATION 26.17 |
| Race/Ethnicity, Customized African American | 6 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants |
| Race/Ethnicity, Customized White | 7 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Clinical Pain Intensity as Assessed by a Visual Analogue Scale (VAS)
Scores on the visual analogue scale (VAS) range from 0 (no pain) to 100 (worst pain imaginable).
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Clinical Pain Intensity as Assessed by a Visual Analogue Scale (VAS) | 24.85 units on a scale | Standard Deviation 22.7 |
Clinical Pain Intensity as Assessed by a Visual Analogue Scale (VAS)
Scores on the visual analogue scale (VAS) range from 0 (no pain) to 100 (worst pain imaginable).
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Clinical Pain Intensity as Assessed by a Visual Analogue Scale (VAS) | 55.23 units on a scale | Standard Deviation 25.45 |
Anxiety as Assessed by the PROMIS Anxiety-short Form
The 7-item PROMIS anxiety-short form assesses the pure domain of anxiety in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Anxiety as Assessed by the PROMIS Anxiety-short Form | 13.6 score on a scale | Standard Deviation 6.73 |
Anxiety as Assessed by the PROMIS Anxiety-short Form
The 7-item PROMIS anxiety-short form assesses the pure domain of anxiety in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Anxiety as Assessed by the PROMIS Anxiety-short Form | 12.05 score on a scale | Standard Deviation 6.86 |
Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Affective Description Subscale
The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = none to 10 = worst possible). The affective description subscale assesses tiring-exhausting, sickening, fearful, and punishing-cruel, and total score on the affective description subscale ranges from 0-40, with a higher score indicating worse pain.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Affective Description Subscale | 11.7 units on a scale | Standard Deviation 11.65 |
Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Affective Description Subscale
The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = none to 10 = worst possible). The affective description subscale assesses tiring-exhausting, sickening, fearful, and punishing-cruel, and total score on the affective description subscale ranges from 0-40, with a higher score indicating worse pain.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Affective Description Subscale | 5.75 units on a scale | Standard Deviation 10.4 |
Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Continuous Pain Subscale
The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = none to 10 = worst possible). The continuous pain subscale assesses throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender, and total score on the continuous pain subscale ranges from 0-60, with a higher score indicating worse pain.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Continuous Pain Subscale | 14.05 units on a scale | Standard Deviation 13.84 |
Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Continuous Pain Summary Scale
The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = none to 10 = worst possible). The continuous pain subscale assesses throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender, and total score on the continuous pain subscale ranges from 0-60, with a higher score indicating worse pain.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Continuous Pain Summary Scale | 22.75 units on a scale | Standard Deviation 15.26 |
Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Intermittent Pain Subscale
The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = none to 10 = worst possible). The intermittent pain subscale assesses shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing, and total score on the intermittent pain subscale ranges from 0-60, with a higher score indicating worse pain.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Intermittent Pain Subscale | 12.90 units on a scale | Standard Deviation 15.8 |
Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Intermittent Pain Subscale
The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = none to 10 = worst possible). The intermittent pain subscale assesses shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing, and total score on the intermittent pain subscale ranges from 0-60, with a higher score indicating worse pain.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Intermittent Pain Subscale | 17.80 units on a scale | Standard Deviation 16.18 |
Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Neuropathic Pain Subscale
The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = none to 10 = worst possible). The neuropathic pain subscale assesses hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or 'pins and needles', and numbness, and total score on the neuropathic pain subscale ranges from 0-60, with a higher score indicating worse pain.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Neuropathic Pain Subscale | 11.1 units on a scale | Standard Deviation 13.71 |
Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Neuropathic Pain Subscale
The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = none to 10 = worst possible). The neuropathic pain subscale assesses hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or 'pins and needles', and numbness, and total score on the neuropathic pain subscale ranges from 0-60, with a higher score indicating worse pain.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Neuropathic Pain Subscale | 8.2 units on a scale | Standard Deviation 14.23 |
Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Functional Impairment Subscale
The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Functional Impairment Subscale | 29.10 units on a scale | Standard Deviation 17.53 |
Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Functional Impairment Subscale
The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Functional Impairment Subscale | 20.85 units on a scale | Standard Deviation 15.22 |
Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Subscale
The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Subscale | 7.95 score on a scale | Standard Deviation 4.39 |
Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Subscale
The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Subscale | 5.75 units on a scale | Standard Deviation 4.25 |
Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Stiffness Subscale
The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Stiffness Subscale | 4.00 units on a scale | Standard Deviation 1.86 |
Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Stiffness Subscale
The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Stiffness Subscale | 2.90 units on a scale | Standard Deviation 1.74 |
Depression as Assessed by the PROMIS Depression-short Form
The 8-item PROMIS depression-short form assesses the pure domain of depression in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Depression as Assessed by the PROMIS Depression-short Form | 11.85 units on a scale | Standard Deviation 6.98 |
Depression as Assessed by the PROMIS Depression-short Form
The 8-item PROMIS depression-short form assesses the pure domain of depression in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Depression as Assessed by the PROMIS Depression-short Form | 12.3 units on a scale | Standard Deviation 7.69 |
Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM)
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). CPM is reported as the change in PPT before and immediately following immersion of the contralateral hand up to the wrist in a cold water bath (12 degrees Celsius) for up to one minute. To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm\^2) per second to the participant's trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful. The pressure at which participants pressed the button to indicate that the pressure sensation ''first becomes painful is reported.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM) | 0.9 kilograms force (kgf) | Standard Deviation 0.7 |
Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM)
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). CPM is reported as the change in PPT before and immediately following immersion of the contralateral hand up to the wrist in a cold water bath (12 degrees Celsius) for up to one minute. To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm\^2) per second to the participant's trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful. The pressure at which participants pressed the button to indicate that the pressure sensation ''first becomes painful is reported.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM) | 1.3 kilograms force (kgf) | Standard Deviation 0.6 |
Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Threshold (HPTH)
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess HPTH, heat stimuli were delivered to the participant's arm or knee using a computer-controlled TSAII NeuroSensory Analyzer. From a baseline of 32 degrees Celsius, the temperature increased by 0.5 degrees Celsius per second until the participants responded by pressing a button to stop heat stimuli. Participants were instructed to press the button when the sensation ''first becomes painful to assess the heat pain threshold (HPTH). The temperature at which participants pressed the button to indicate the sensation ''first becomes painful is reported.
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation | Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Threshold (HPTH) | arm | 37.3 degrees Celsius | Standard Deviation 2 |
| Transcranial Direct Current Stimulation | Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Threshold (HPTH) | knee | 40.1 degrees Celsius | Standard Deviation 3.4 |
Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Threshold (HPTH)
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess HPTH, heat stimuli were delivered to the participant's arm or knee using a computer-controlled TSAII NeuroSensory Analyzer. From a baseline of 32 degrees Celsius, the temperature increased by 0.5 degrees Celsius per second until the participants responded by pressing a button to stop heat stimuli. Participants were instructed to press the button when the sensation ''first becomes painful to assess the heat pain threshold (HPTH). The temperature at which participants pressed the button to indicate the sensation ''first becomes painful is reported.
Time frame: baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation | Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Threshold (HPTH) | arm | 37.9 degrees Celsius | Standard Deviation 3.3 |
| Transcranial Direct Current Stimulation | Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Threshold (HPTH) | knee | 39.1 degrees Celsius | Standard Deviation 3.5 |
Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Tolerance (HPTO)
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess HPTO, heat stimuli were delivered to the participant's arm or knee using a computer-controlled TSAII NeuroSensory Analyzer. From a baseline of 32 degrees Celsius, the temperature increased by 0.5 degrees Celsius per second until the participants responded by pressing a button to stop heat stimuli. Participants were instructed to press the button when they ''no longer feel able to tolerate the pain. The temperature at which participants pressed the button to indicate they could ''no longer feel able to tolerate the pain is reported.
Time frame: baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation | Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Tolerance (HPTO) | arm | 43.2 degrees Celsius | Standard Deviation 3.1 |
| Transcranial Direct Current Stimulation | Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Tolerance (HPTO) | knee | 43.1 degrees Celsius | Standard Deviation 3.3 |
Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Tolerance (HPTO)
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess HPTO, heat stimuli were delivered to the participant's arm or knee using a computer-controlled TSAII NeuroSensory Analyzer. From a baseline of 32 degrees Celsius, the temperature increased by 0.5 degrees Celsius per second until the participants responded by pressing a button to stop heat stimuli. Participants were instructed to press the button when they ''no longer feel able to tolerate the pain. The temperature at which participants pressed the button to indicate they could ''no longer feel able to tolerate the pain is reported.
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation | Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Tolerance (HPTO) | arm | 43.2 degrees Celsius | Standard Deviation 3.2 |
| Transcranial Direct Current Stimulation | Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Tolerance (HPTO) | knee | 44.6 degrees Celsius | Standard Deviation 3.1 |
Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm\^2) per second to the participant's medial knee, lateral knee, or trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful. The pressure at which participants pressed the button to indicate that the pressure sensation ''first becomes painful is reported.
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation | Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT) | medial knee | 3.7 kilograms force (kgf) | Standard Deviation 1.2 |
| Transcranial Direct Current Stimulation | Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT) | lateral knee | 4.4 kilograms force (kgf) | Standard Deviation 1.3 |
| Transcranial Direct Current Stimulation | Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT) | trapezius | 3.9 kilograms force (kgf) | Standard Deviation 1.3 |
Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm\^2) per second to the participant's medial knee, lateral knee, or trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful. The pressure at which participants pressed the button to indicate that the pressure sensation ''first becomes painful is reported.
Time frame: baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation | Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT) | medial knee | 3.2 kilograms force (kgf) | Standard Deviation 1.4 |
| Transcranial Direct Current Stimulation | Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT) | lateral knee | 3.5 kilograms force (kgf) | Standard Deviation 1.5 |
| Transcranial Direct Current Stimulation | Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT) | trapezius | 2.9 kilograms force (kgf) | Standard Deviation 1.6 |
Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Punctate Mechanical Pain (PMP)
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess PMP, punctate mechanical pain is delivered to the patella or hand by a calibrated nylon monofilament for 10 contacts of the monofilament at one contact per second. Participants rate the pain intensity on a scale from 0 (no pain) to 100 (maximum imaginable pain).
Time frame: baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation | Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Punctate Mechanical Pain (PMP) | patella | 84.7 score on a scale | Standard Deviation 23.4 |
| Transcranial Direct Current Stimulation | Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Punctate Mechanical Pain (PMP) | hand | 66.0 score on a scale | Standard Deviation 27 |
Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Punctate Mechanical Pain (PMP)
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM). To assess PMP, punctate mechanical pain is delivered to the patella or hand by a calibrated nylon monofilament for 10 contacts of the monofilament at one contact per second. Participants rate the pain intensity on a scale from 0 (no pain) to 100 (maximum imaginable pain).
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation | Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Punctate Mechanical Pain (PMP) | patella | 67.4 score on a scale | Standard Deviation 26.9 |
| Transcranial Direct Current Stimulation | Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Punctate Mechanical Pain (PMP) | hand | 54.6 score on a scale | Standard Deviation 23.9 |
Feasibility as Assessed by a Survey of Participants' tDCS Experience - Ease of Preparation of Device
Data will be collected on participants' tDCS experience at the conclusion of tDCS treatment on a scale of 0 (strongly disagree) to 10 (strongly agree): Q2) It was easy to prepare the device and accessories
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Feasibility as Assessed by a Survey of Participants' tDCS Experience - Ease of Preparation of Device | 9.75 score on a scale | Standard Deviation 0.44 |
Feasibility as Assessed by a Survey of Participants' tDCS Experience - Ease of Using Device
Data will be collected on participants' tDCS experience at the conclusion of tDCS treatment on a scale of 0 (strongly disagree) to 10 (strongly agree): Q1) Overall the device was easy to use
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Feasibility as Assessed by a Survey of Participants' tDCS Experience - Ease of Using Device | 9.75 score on a scale | Standard Deviation 0.44 |
Feasibility as Assessed by a Survey of Participants' tDCS Experience - Effectiveness of Treatment Over Time
Data will be collected on participants' tDCS experience at the conclusion of tDCS treatment on a scale of 0 (strongly disagree) to 10 (strongly agree): Q3) The effectiveness of the treatment increased over the course of treatment.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Feasibility as Assessed by a Survey of Participants' tDCS Experience - Effectiveness of Treatment Over Time | 6.75 score on a scale | Standard Deviation 3.17 |
Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy (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 pain stimulation.
Time frame: 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcranial Direct Current Stimulation | Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy (fNIRS) | 20 Participants |
Sleep Disturbance as Assessed by the PROMIS Sleep Disturbance-short Form
The 8-item PROMIS sleep disturbance-short form assesses the pure domain of sleep disturbance in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Sleep Disturbance as Assessed by the PROMIS Sleep Disturbance-short Form | 24.3 units on a scale | Standard Deviation 7.87 |
Sleep Disturbance as Assessed by the PROMIS Sleep Disturbance-short Form
The 8-item PROMIS sleep disturbance-short form assesses the pure domain of sleep disturbance in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Sleep Disturbance as Assessed by the PROMIS Sleep Disturbance-short Form | 19.85 units on a scale | Standard Deviation 8.1 |
Tolerability as Assessed by Number of Participants With Side Effects
The participants will be asked in an open-ended manner whether they have experienced any side effects, and they will then be asked specifically about tingling, itching sensation, burning sensation, pain at the stimulation site, fatigue, nervousness, headache, difficulty concentrating, mood change, and changes in vision or visual perception.
Time frame: 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcranial Direct Current Stimulation | Tolerability as Assessed by Number of Participants With Side Effects | 0 Participants |