Back to resultsHome-based tDCS and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms
Primary Purpose
Osteo Arthritis Knee
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
active tDCS paired with active MBM
sham tDCS paired with active MBM
active tDCS paired with sham MBM
sham tDCS paired with sham MBM
Sponsored by
About this trial
This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring meditation
Eligibility 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.
Sites / Locations
- University of ArizonaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Sham Comparator
Arm Label
active tDCS paired with active MBM,
sham tDCS paired with active MBM
active tDCS paired with sham MBM
sham tDCS paired with sham MBM
Arm Description
Outcomes
Primary Outcome Measures
Numeric Rating Score (NRS) of Pain
Clinical pain intensity will be measured by asking participants to rate average knee pain over the past 24 hours via NRS from 0 (no pain) to 100 (worst pain imaginable), as in the investigator's previous pilot trial. The NRS has a reported Cronbach's alpha coefficient of ≥ 0.8 and is a well-validated measure with good ability to detect pain change in adults with knee OA.
Secondary Outcome Measures
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
This is a 5 item questionnaire each with a score ranging from none to extreme
Functional near-infrared spectroscopy (fNIRS) brain imaging
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.
Conditioned Pain Modulation (CPM)
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.
Freiburg Mindfulness Inventory (FMI)
Freiburg Mindfulness Inventory (FMI) will measure levels of mindfulness among participants. It is a 14-item instrument (range, 14 to 56), with higher scores indicating more skill with the mindfulness technique. The FMI has a reported Cronbach's alpha coefficient of 0.86.
Client Satisfaction Questionnaire (CSQ-8)
Client Satisfaction Questionnaire (CSQ-8) will measure participants' satisfaction with treatment. The CSQ-8 comprises eight items that are summed to yield an overall score of 8-32, with higher scores indicating greater satisfaction. The CSQ-8 has a reported Cronbach's alpha coefficient of 0.87-0.93.
Side effects questionnaire
Side effects questionnaire will be evaluated for the presence and severity of possible side effects of treatment at the end of each session on a 0 (not at all) to 10 (highest degree) scale. The participants will be asked in an open-ended manner whether any side effects are experienced, and participants will complete a brief questionnaire assessing side effects of treatment, including side effects that can occur with tDCS or MBM (e.g., itching, headache, fatigue, dizziness).
Full Information
NCT ID
NCT04375072
First Posted
April 30, 2020
Last Updated
September 20, 2023
Sponsor
University of Arizona
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT04375072
Brief Title
Home-based tDCS and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 13, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
Keywords
meditation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
active tDCS paired with active MBM,
Arm Type
Experimental
Arm Title
sham tDCS paired with active MBM
Arm Type
Active Comparator
Arm Title
active tDCS paired with sham MBM
Arm Type
Active Comparator
Arm Title
sham tDCS paired with sham MBM
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
active tDCS paired with active MBM
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham tDCS paired with active MBM
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
active tDCS paired with sham MBM
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham tDCS paired with sham MBM
Intervention Description
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 Measure Information:
Title
Numeric Rating Score (NRS) of Pain
Description
Clinical pain intensity will be measured by asking participants to rate average knee pain over the past 24 hours via NRS from 0 (no pain) to 100 (worst pain imaginable), as in the investigator's previous pilot trial. The NRS has a reported Cronbach's alpha coefficient of ≥ 0.8 and is a well-validated measure with good ability to detect pain change in adults with knee OA.
Time Frame
14 time points: baseline,after each treatment session during the treatment period, and three follow-up assessments (months 1, 2,and 3 postintervention)
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
This is a 5 item questionnaire each with a score ranging from none to extreme
Time Frame
6 time points: baseline, weekly during the treatment period, and three follow-up assessments (months 1, 2,and 3 post-intervention)
Title
Functional near-infrared spectroscopy (fNIRS) brain imaging
Description
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.
Time Frame
3 time points (baseline and weekly during the treatment period)
Title
Conditioned Pain Modulation (CPM)
Description
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.
Time Frame
3 time points (baseline and weekly during the treatment period)
Title
Freiburg Mindfulness Inventory (FMI)
Description
Freiburg Mindfulness Inventory (FMI) will measure levels of mindfulness among participants. It is a 14-item instrument (range, 14 to 56), with higher scores indicating more skill with the mindfulness technique. The FMI has a reported Cronbach's alpha coefficient of 0.86.
Time Frame
6 time points: baseline, weekly during the treatment period, and three follow-up assessments (months 1, 2, and 3 post intervention)
Title
Client Satisfaction Questionnaire (CSQ-8)
Description
Client Satisfaction Questionnaire (CSQ-8) will measure participants' satisfaction with treatment. The CSQ-8 comprises eight items that are summed to yield an overall score of 8-32, with higher scores indicating greater satisfaction. The CSQ-8 has a reported Cronbach's alpha coefficient of 0.87-0.93.
Time Frame
at the end of 2-week intervention
Title
Side effects questionnaire
Description
Side effects questionnaire will be evaluated for the presence and severity of possible side effects of treatment at the end of each session on a 0 (not at all) to 10 (highest degree) scale. The participants will be asked in an open-ended manner whether any side effects are experienced, and participants will complete a brief questionnaire assessing side effects of treatment, including side effects that can occur with tDCS or MBM (e.g., itching, headache, fatigue, dizziness).
Time Frame
10 time points: 5 times a week daily for up to 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyochol Ahn, PhD,RN,MSN
Phone
520-626-1769
Email
hbrian@arizona.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyochol Ahn, PhD,RN,MSN
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85721
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyochol Ahn, PhD,RN,MSN
Phone
520-626-1769
Email
hbrian@arizona.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Home-based tDCS and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms
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