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Completed

NCT Number: NCT03747640

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

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 (OA).

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self Transcranial Direct Current Stimulation (tDCS)

Device

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 (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.

Mindfulness-based meditation

Behavioral

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 Self Transcranial Direct Current Stimulation (tDCS)

Device

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.

sham meditation

Behavioral

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 outcomes

  1. Change in Clinical Pain as Assessed by a Numeric Rating Scale for Pain (NRS)

    Time frame: baseline, 2 weeks

    The NRS assess average pain over the past 24 hours from 0 (no pain) to 100 (most intense pain imaginable).

Secondary outcomes

  1. Change in Clinical Pain 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 osteoarthritis (OA) pain-related symptoms.

  2. Psychosocial Symptoms as Assessed by the Patient-Reported Outcomes Measurement Information System (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.

  3. Psychosocial Symptoms as Assessed by the 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. Change in Experimental Pain Sensitivity as Assessed by Conditioned Pain Modulation

    Time frame: baseline, 2 weeks

    Conditioned Pain Modulation (CPM) was assessed as the change in PPT on the trapezius immediately after the immersion of the contralateral hand up to the wrist in a cold-water bath (Neslab, Portsmouth, NH) at 12 degrees C for 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" to assess pressure pain threshold (PPT).]

  13. Number of Participants Who Were 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.

  14. Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy

    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.

  15. Change in Experimental Pain Sensitivity as Assessed by Cold Pain Intensity

    Time frame: baseline, 2 weeks

    Participants immersed their hand in a cold water bath, and at thirty seconds after hand immersion, they rated the cold pain intensity on a scale of 0-100. A higher score indicating higher pain intensity.

  16. Change in Experimental Pain Sensitivity as Assessed by Pressure Pain Threshold, Lateral Knee

    Time frame: baseline, 2 weeks

    To assess pressure pain threshold (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 knee. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT).

  17. Change in Experimental Pain Sensitivity as Assessed by Pressure Pain Threshold, Medial Knee

    Time frame: baseline, 2 weeks

    To assess pressure pain threshold (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 knee. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT).

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study 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)

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 20, 2018
Registry last updated
Mar 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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