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

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ClinicalTrials.gov Identifier: NCT03425019
Recruitment Status : Recruiting
First Posted : February 7, 2018
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Hyochol Ahn, The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date  ICMJE January 30, 2018
First Posted Date  ICMJE February 7, 2018
Last Update Posted Date November 20, 2018
Actual Study Start Date  ICMJE March 14, 2018
Estimated Primary Completion Date February 5, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2018)
Change in clinical pain intensity as assessed by a visual analogue scale (VAS) [ Time Frame: baseline, 2 weeks ]
Scores on the visual analogue scale (VAS) range from 0 (no pain) to 10 (worst pain imaginable).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03425019 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2018)
  • Change in clinical pain intensity as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: baseline, 2 weeks ]
    The WOMAC ranges from 0 to 96, with higher scores indicating worse OA pain-related symptoms.
  • Change in clinical pain intensity as assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) [ Time Frame: baseline, 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 SF-MPQ-2 is comprised of four summary scales: (1) continuous descriptors (throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender), (2) intermittent descriptors (shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing), (3) neuropathic descriptors (hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or 'pins and needles', and numbness), and (4) affective descriptors (tiring-exhausting, sickening, fearful, and punishing-cruel). A total pain score is computed by averaging participant ratings across all questions.
  • Change in experimental pain sensitivity as assessed by a multimodal Quantitative Sensory Testing (QST) battery [ Time Frame: baseline, 2 weeks ]
    In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain sensitivity, pressure pain sensitivity, punctate mechanical pain, and Conditioned Pain Modulation (CPM).
  • Change in pain-related cortical response as assessed by functional near-infrared spectroscopy (fNIRS) [ Time Frame: baseline, 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 [ Time Frame: 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"; Q2) "It was easy to prepare the device and accessories"; and Q3) "The effectiveness of the treatment increased over the course of treatment."
  • Tolerability as assessed by severity of side effects [ Time Frame: 2 weeks ]
    The presence and severity of possible side effects of treatment at the end of each session will be assessed on a scale of 0 (not at all) to 10 (highest degree). 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.
  • Change in anxiety as assessed by the PROMIS anxiety-short form [ Time Frame: baseline, 2 weeks ]
    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.
  • Change in depression as assessed by the PROMIS depression-short form [ Time Frame: baseline, 2 weeks ]
    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.
  • Change in sleep disturbance as assessed by the PROMIS sleep disturbance-short form [ Time Frame: baseline, 2 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2018)
  • Change in clinical pain intensity as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: baseline, 2 weeks ]
    The WOMAC ranges from 0 to 96, with higher scores indicating worse OA pain-related symptoms.
  • Change in clinical pain intensity as assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) [ Time Frame: baseline, 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 SF-MPQ-2 is comprised of four summary scales: (1) continuous descriptors (throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender), (2) intermittent descriptors (shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing), (3) neuropathic descriptors (hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or 'pins and needles', and numbness), and (4) affective descriptors (tiring-exhausting, sickening, fearful, and punishing-cruel). A total pain score is computed by averaging participant ratings across all questions.
  • Change in experimental pain sensitivity as assessed by a multimodal Quantitative Sensory Testing (QST) battery [ Time Frame: baseline, 2 weeks ]
    In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain sensitivity, pressure pain sensitivity, punctate mechanical pain, and Conditioned Pain Modulation (CPM).
  • Change in pain-related cortical response as assessed by functional near-infrared spectroscopy (fNIRS) [ Time Frame: baseline, 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 [ Time Frame: 2 weeks ]
    Data will be colledted 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"; Q2) "It was easy to prepare the device and accessories"; and Q3) "The effectiveness of the treatment increased over the course of treatment."
  • Tolerability as assessed by severity of side effects [ Time Frame: 2 weeks ]
    The presence and severity of possible side effects of treatment at the end of each session will be assessed on a scale of 0 (not at all) to 10 (highest degree). 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.
  • Change in anxiety as assessed by the PROMIS anxiety-short form [ Time Frame: baseline, 2 weeks ]
    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.
  • Change in depression as assessed by the PROMIS depression-short form [ Time Frame: baseline, 2 weeks ]
    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.
  • Change in sleep disturbance as assessed by the PROMIS sleep disturbance-short form [ Time Frame: baseline, 2 weeks ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Self Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis
Official Title  ICMJE Self Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis (Self tDCS and Knee Pain)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Knee Osteoarthritis
  • Chronic Pain
Intervention  ICMJE Device: 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.
Study Arms  ICMJE Experimental: 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.
Intervention: Device: Transcranial Direct Current Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 5, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 5, 2020
Estimated Primary Completion Date February 5, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hyochol Ahn, PhD 713-500-2179 Hyochol.Ahn@uth.tmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03425019
Other Study ID Numbers  ICMJE HSC-SN-17-1072
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hyochol Ahn, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hyochol Ahn, PhD The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP