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Self Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Pain in Older Adults With Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03747640
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : April 10, 2019
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 a two-week self tDCS and mindfulness-based meditation for pain in older adults with knee osteoarthritis.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: Self Transcranial Direct Current Stimulation (tDCS) Behavioral: mindfulness-based meditation Device: Sham Self Transcranial Direct Current Stimulation (tDCS) Behavioral: sham meditation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Self Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Pain in Older Adults With Knee Osteoarthritis (Self tDCS and Meditation for Knee Pain)
Actual Study Start Date : November 28, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: tDCS with mindfulness-based meditation
Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation
Device: Self Transcranial Direct Current Stimulation (tDCS)
tDCS with a constant current intensity of 2 mA will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device (Soterix Medical Inc., NY; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.

Behavioral: mindfulness-based meditation
The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.

Sham Comparator: sham tDCS with sham meditation
Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation
Device: Sham Self Transcranial Direct Current Stimulation (tDCS)
For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds.

Behavioral: sham meditation
For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.




Primary Outcome Measures :
  1. Clinical pain as assessed by a numeric rating scale for pain (NRS) [ Time Frame: baseline ]
    The NRS assess average pain over the past 24 hours from 0 (no pain) to 100 (most intense pain imaginable).

  2. Clinical pain as assessed by a numeric rating scale for pain (NRS) [ Time Frame: 2 weeks ]
    The NRS assess average pain over the past 24 hours from 0 (no pain) to 100 (most intense pain imaginable).


Secondary Outcome Measures :
  1. Clinical pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: baseline ]
    The WOMAC ranges from 0 to 96, with higher scores indicating worse OA pain-related symptoms.

  2. Clinical pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: 2 weeks ]
    The WOMAC ranges from 0 to 96, with higher scores indicating worse OA pain-related symptoms.

  3. Psychosocial symptoms as assessed by PROMIS anxiety-short form [ Time Frame: 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.

  4. Psychosocial symptoms as assessed by PROMIS anxiety-short form [ Time Frame: 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.

  5. Psychosocial symptoms as assessed by PROMIS depression-short form [ Time Frame: 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.

  6. Psychosocial symptoms as assessed by PROMIS depression-short form [ Time Frame: 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.

  7. Psychosocial symptoms as assessed by PROMIS sleep disturbance-short form [ Time Frame: 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.

  8. Psychosocial symptoms as assessed by PROMIS sleep disturbance-short form [ Time Frame: 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.

  9. Psychosocial symptoms as assessed by the Pain Catastrophizing Scale (PCS) [ Time Frame: baseline ]
    The Pain Catastrophizing Scale (PCS) consists of 13 items assessing three components of catastrophizing: rumination, magnification, and helplessness. Each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time).The PCS total score is computed by summing responses to all 13 items, with total scores ranging from 0 - 52. Higher scores indicate a worse outcome.

  10. Psychosocial symptoms as assessed by the Pain Catastrophizing Scale (PCS) [ Time Frame: 2 weeks ]
    The Pain Catastrophizing Scale (PCS) consists of 13 items assessing three components of catastrophizing: rumination, magnification, and helplessness. Each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time).The PCS total score is computed by summing responses to all 13 items, with total scores ranging from 0 - 52. Higher scores indicate a worse outcome.

  11. Psychosocial symptoms as assessed by the Freiburg Mindfulness Inventory (FMI) [ Time Frame: baseline ]
    The Freiburg Mindfulness Inventory (FMI) is a 14-item instrument. Respondents indicate their experiences relating to the items on a 4-point Likert scale (rarely, occasionally, fairly often and almost always), and the total score is calculated by adding all the scores on the 14 items of the FMI. Total scores range from 14-56, with higher scores indicating higher levels of mindfulness.

  12. Psychosocial symptoms as assessed by the Freiburg Mindfulness Inventory (FMI) [ Time Frame: 2 weeks ]
    The Freiburg Mindfulness Inventory (FMI) is a 14-item instrument. Respondents indicate their experiences relating to the items on a 4-point Likert scale (rarely, occasionally, fairly often and almost always), and the total score is calculated by adding all the scores on the 14 items of the FMI. Total scores range from 14-56, with higher scores indicating higher levels of mindfulness.

  13. Experimental pain sensitivity as assessed by conditioned pain modulation [ Time Frame: baseline ]
    In order to measure experimental pain sensitivity, Conditioned Pain Modulation (CPM) will be completed.

  14. Experimental pain sensitivity as assessed by conditioned pain modulation [ Time Frame: 2 weeks ]
    In order to measure experimental pain sensitivity, Conditioned Pain Modulation (CPM) will be completed.

  15. Pain-related cortical response as assessed by functional near-infrared spectroscopy (fNIRS) [ Time Frame: baseline ]
    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.

  16. Pain-related cortical response as assessed by functional near-infrared spectroscopy (fNIRS) [ Time Frame: 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.



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • self-reported unilateral or bilateral knee OA pain, according to American College of Rheumatology criteria. According to American College of Rheumatology criteria, participants should meet at least 3 of 6 criteria, including age > 50 years, stiffness < 30 minutes, crepitus, bony tenderness, bony enlargement, and no palpable warmth.
  • have had knee OA pain in the past 3 months with an average of at least 30 on a 100 Numeric Rating Scale (NRS) 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 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:

  • Participants will be excluded if they have concurrent medical conditions that hinder the completion of the protocol, including any of the following
  • history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation
  • serious medical illness, such as uncontrolled hypertension (i.e., systolic blood pressure/ diastolic blood pressure ≥ 150/95 mm Hg), heart failure, or history of acute myocardial infarction
  • alcohol/substance abuse
  • cognitive impairment
  • 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): NCT03747640


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

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

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Responsible Party: Hyochol Ahn, Associate Professor & Theodore J. and Mary E. Trumble Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03747640     History of Changes
Other Study ID Numbers: HSC-SN-18-0885
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases