Clinical trial NCT03747640: Self Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Pain in Older Adults With Knee Osteoarthritis
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (OA).


Eligibility 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

Primary outcomes:
measure: Change in Clinical Pain as Assessed by a Numeric Rating Scale for Pain (NRS)
timeFrame: baseline, 2 weeks
Secondary outcomes:
measure: Change in Clinical Pain as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: baseline, 2 weeks
measure: Psychosocial Symptoms as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety-short Form
timeFrame: baseline
measure: Psychosocial Symptoms as Assessed by the PROMIS Anxiety-short Form
timeFrame: 2 weeks
measure: Psychosocial Symptoms as Assessed by PROMIS Depression-short Form
timeFrame: baseline
measure: Psychosocial Symptoms as Assessed by PROMIS Depression-short Form
timeFrame: 2 weeks
measure: Psychosocial Symptoms as Assessed by PROMIS Sleep Disturbance-short Form
timeFrame: baseline
measure: Psychosocial Symptoms as Assessed by PROMIS Sleep Disturbance-short Form
timeFrame: 2 weeks
measure: Psychosocial Symptoms as Assessed by the Pain Catastrophizing Scale (PCS)
timeFrame: baseline
measure: Psychosocial Symptoms as Assessed by the Pain Catastrophizing Scale (PCS)
timeFrame: 2 weeks
measure: Psychosocial Symptoms as Assessed by the Freiburg Mindfulness Inventory (FMI)
timeFrame: baseline
measure: Psychosocial Symptoms as Assessed by the Freiburg Mindfulness Inventory (FMI)
timeFrame: 2 weeks
measure: Change in Experimental Pain Sensitivity as Assessed by Conditioned Pain Modulation
timeFrame: baseline, 2 weeks
measure: Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy (fNIRS)
timeFrame: baseline
measure: Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy
timeFrame: 2 weeks
measure: Change in Experimental Pain Sensitivity as Assessed by Cold Pain Intensity
timeFrame: baseline, 2 weeks
measure: Change in Experimental Pain Sensitivity as Assessed by Pressure Pain Threshold, Lateral Knee
timeFrame: baseline, 2 weeks
measure: Change in Experimental Pain Sensitivity as Assessed by Pressure Pain Threshold, Medial Knee
timeFrame: baseline, 2 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Hyochol Ahn, PhD, RN, MSN
role: PRINCIPAL_INVESTIGATOR
References: