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Knee OsteoarthritisNCT03425019

Self Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis

A study testing Soterix 1x1 tDCS mini-CT Stimulator device in people with Knee Osteoarthritis and Chronic Pain, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Knee Osteoarthritis, Chronic Pain
What is being tested?
Soterix 1x1 tDCS mini-CT Stimulator device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
14 Mar 2018to 5 Oct 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Self Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis (Self tDCS and Knee Pain)

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).

Being tested
Soterix 1x1 tDCS mini-CT Stimulator device
Keywords
Knee Osteoarthritis, Chronic Pain, Osteoarthritis, Transcranial Direct Current Stimulation, tDCS
Medical subject headings
Osteoarthritis, Knee, Chronic Pain, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Soterix 1x1 tDCS mini-CT Stimulator deviceDevice

    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.

Study groups in NCT03425019
Study groupRoleWhat they receive
Transcranial Direct Current StimulationExperimentalTranscranial 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 milliamps (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.
Receives: Device: Soterix 1x1 tDCS mini-CT Stimulator device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: baseline

  2. 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).

    Measured: 2 weeks

Secondary outcomes (35)
  1. 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.

    Measured: baseline

  2. 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.

    Measured: 2 weeks

  3. 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.

    Measured: baseline

  4. 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.

    Measured: 2 weeks

  5. 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.

    Measured: baseline

  6. 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.

    Measured: 2 weeks

  7. 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.

    Measured: baseline

  8. 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.

    Measured: 2 weeks

  9. 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.

    Measured: baseline

  10. 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.

    Measured: 2 weeks

  11. 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.

    Measured: baseline

  12. 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.

    Measured: 2 weeks

  13. 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.

    Measured: baseline

  14. 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.

    Measured: 2 weeks

  15. 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.

    Measured: baseline

  16. 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.

    Measured: 2 weeks

  17. 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.

    Measured: baseline

  18. 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.

    Measured: 2 weeks

  19. 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.

    Measured: baseline

  20. 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.

    Measured: 2 weeks

  21. 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).

    Measured: baseline

  22. 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).

    Measured: 2 weeks

  23. 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.

    Measured: baseline

  24. 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.

    Measured: 2 weeks

  25. 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.

    Measured: 2 weeks

  26. 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"

    Measured: 2 weeks

  27. 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"

    Measured: 2 weeks

  28. 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."

    Measured: 2 weeks

  29. 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.

    Measured: 2 weeks

  30. 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.

    Measured: baseline

  31. 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.

    Measured: 2 weeks

  32. 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.

    Measured: baseline

  33. 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.

    Measured: 2 weeks

  34. 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.

    Measured: baseline

  35. 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.

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2018
  2. Study start14 Mar 2018
  3. Primary completion5 Oct 2018
  4. Study completion5 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03425019
Sponsor's protocol ID
HSC-SN-17-1072
Status last verified
Sep 2021
First submitted
30 Jan 2018
Last updated
15 Oct 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Ahn H, Sorkpor S, Miao H, Zhong C, Jorge R, Park L, Abdi S, Cho RY. Home-based self-administered transcranial direct current stimulation in older adults with knee osteoarthritis pain: An open-label study. J Clin Neurosci. 2019 Aug;66:61-65. doi: 10.1016/j.jocn.2019.05.023. Epub 2019 May 29.

    PubMed 31153751

Questions about this trial

What is this clinical trial studying?

A study testing Soterix 1x1 tDCS mini-CT Stimulator device in people with Knee Osteoarthritis and Chronic Pain, run by The University of Texas Health Science Center, Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Pain Intensity as Assessed by a Visual Analogue Scale (VAS) (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03425019, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.

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