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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

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).

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Chronic Pain Device: Transcranial Direct Current Stimulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Self Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis (Self tDCS and Knee Pain)
Actual Study Start Date : March 14, 2018
Estimated Primary Completion Date : February 5, 2020
Estimated Study Completion Date : February 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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."

  6. 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.

  7. 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.

  8. 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.

  9. 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.



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03425019


Contacts
Contact: Hyochol Ahn, PhD 713-500-2179 Hyochol.Ahn@uth.tmc.edu

Locations
United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Hyochol Ahn, PhD    713-500-2179    Hyochol.Ahn@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Hyochol Ahn, PhD The University of Texas Health Science Center, Houston

Responsible Party: Hyochol Ahn, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03425019     History of Changes
Other Study ID Numbers: HSC-SN-17-1072
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018

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

Keywords provided by Hyochol Ahn, The University of Texas Health Science Center, Houston:
Knee Osteoarthritis
Chronic Pain
Osteoarthritis
Transcranial Direct Current Stimulation
tDCS

Additional relevant MeSH terms:
Chronic Pain
Pain
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms