Clinical trial NCT04375072: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: meditation
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2020-05-05
Enrollment: 200
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 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.


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.

Primary outcomes:
measure: Numeric Rating Score (NRS) of Pain
timeFrame: 14 time points: baseline,after each treatment session during the treatment period, and three follow-up assessments (months 1, 2,and 3 postintervention)
Secondary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 6 time points: baseline, weekly during the treatment period, and three follow-up assessments (months 1, 2,and 3 post-intervention)
measure: Functional near-infrared spectroscopy (fNIRS) brain imaging
timeFrame: 3 time points (baseline and weekly during the treatment period)
measure: Conditioned Pain Modulation (CPM)
timeFrame: 3 time points (baseline and weekly during the treatment period)
measure: Freiburg Mindfulness Inventory (FMI)
timeFrame: 6 time points: baseline, weekly during the treatment period, and three follow-up assessments (months 1, 2, and 3 post intervention)
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: at the end of 2-week intervention
measure: Side effects questionnaire
timeFrame: 10 time points: 5 times a week daily for up to 2 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Hyochol Ahn, PhD,RN,MSN
role: PRINCIPAL_INVESTIGATOR
References: