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Combination Therapy of Home-based Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms in Older Adults With Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT04375072
Recruitment Status : Not yet recruiting
First Posted : May 5, 2020
Last Update Posted : July 2, 2020
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
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 effects of active transcranial direct current stimulation (tDCS) paired with active mindfulness-based meditation (MBM) on clinical pain,osteo arthritis (OA)-related clinical symptoms, physiopsychological pain processing and participant satisfaction with treatment in patients with knee OA.

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Device: active tDCS paired with active MBM Device: sham tDCS paired with active MBM Device: active tDCS paired with sham MBM Device: sham tDCS paired with sham MBM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combination Therapy of Home-based Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms in Older Adults With Knee Osteoarthritis
Estimated Study Start Date : July 18, 2020
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : January 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: active tDCS paired with active MBM, Device: active tDCS paired with active MBM
Active tDCS with a constant current intensity of 2 milli ampere( mA)will be applied for 20 minutes per session daily for 2 weeks via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session daily for 2 weeks by a recorded meditation.

Active Comparator: sham tDCS paired with active MBM Device: sham tDCS paired with active MBM
For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2(milli ampere) mA current for 30 seconds. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session daily for 2 weeks by a recorded meditation.

Active Comparator: active tDCS paired with sham MBM Device: active tDCS paired with sham MBM
Active tDCS with a constant current intensity of 2 mA will be applied for 20 minutes per session daily for 2 weeks via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM.

Sham Comparator: sham tDCS paired with sham MBM Device: sham tDCS paired with sham MBM
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. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM.




Primary Outcome Measures :
  1. Change in clinical pain as assessed by the numeric rating scale (NRS) for pain [ Time Frame: baseline, week 2 ]
    The NRS total score ranges from 0 (no pain) to 100 (most intense pain imaginable).


Secondary Outcome Measures :
  1. Change in osteo arthritis symptoms as measured by the Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) [ Time Frame: baseline, week 2 ]
    This is a 5 item questionnaire each with a score ranging from none to extreme

  2. Change in pain related cortical response using a continuous wave, multichannel Functional near-infrared spectroscopy (fNIRS) imaging system [ Time Frame: baseline, week 2 ]
    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.

  3. Descending pain modulation (CPM) as measured by the quantitative sensory testing [ Time Frame: baseline, week 2 ]
    Descending pain modulation will be determined by the change in pressure pain threshold on the trapezius immediately after the immersion of the contralateral hand up to the wrist in a cold water bath at 12°C for one minute, with higher CPM scores indicating better descending pain modulation. Descending pain modulation will be reflected by an increase in pressure pain threshold after cold water immersion.

  4. Change in mindfulness as measured by the Freiburg Mindfulness Inventory (FMI) [ Time Frame: baseline, week 2 ]
    This is a 14 item questionnaire,each scored from 1-4,higher number showing better outcome

  5. Patient satisfaction as measured by the Client Satisfaction Questionnaire (CSQ-8) scale [ Time Frame: week 2 ]
    This scale has 8 questions,each scored from 1-4,higher number indicating more satisfaction



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • have symptomatic knee OA based on American College of Rheumatology clinical criteria
  • have had knee OA pain in the past 3 months with an average of at least 30 on a 0-100 NRS for pain,
  • can speak and read English
  • have no plan to change medication regimens for pain throughout the trial

Exclusion Criteria:

  • history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation
  • systemic rheumatic disorders, including rheumatoid arthritis,systemic lupus erythematosus, and fibromyalgia
  • alcohol/substance abuse
  • current use of sodium channel blockers, calcium channel blockers, or N-Methyl-D-aspartate receptor antagonists
  • diminished cognitive function that would interfere with understanding study procedures (i.e., Mini-Mental Status Exam score ≤ 23)
  • pregnancy or lactation
  • prosthetic knee replacement or non-arthroscopic surgery to the affected knee
  • hospitalization within the preceding year for psychiatric illness
  • no access to a device that can be used for secure videoconferencing for real-time remote supervision.

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): NCT04375072


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
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
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Hyochol Hyochol, Phd,RN,MSN The University of Texas Health Science Center, Houston
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Responsible Party: Hyochol Ahn, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04375072    
Other Study ID Numbers: HSC-SN-19-1050
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: July 2020
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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hyochol Ahn, The University of Texas Health Science Center, Houston:
meditation
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases