Clinical trial NCT04016272: Self-Administered Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis
Official title: Self-Administered Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis: A Phase II Randomized Sham-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2019-07-11
Enrollment: 123
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 assess the feasibility, acceptability, and efficacy of self-administered transcranial direct current stimulation (tDCS) in older adults with knee osteoarthritis (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:

* prosthetic knee replacement or nonarthroscopic surgery to the affected knee
* 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 and NMDS receptor antagonists
* diminished cognitive function that would interfere with understanding study procedures(i.e., Mini-Mental Status Exam score ≤ 23)
* pregnancy or lactation
* hospitalization within the preceding year for psychiatric illness
* no access to a device with internet access that can be used for secure videoconferencing for real-time remote supervision

Primary outcomes:
measure: Change in Clinical Pain as Assessed by the Numeric Rating Scale (NRS) for Pain
timeFrame: baseline, week 3
Secondary outcomes:
measure: Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System
timeFrame: Baseline, week1, week2, and week 3
measure: Acceptability as Measured by the tDCs Experience Questionnaire
timeFrame: week 3
measure: Number of Participants With Possible Side Effects of Treatment
timeFrame: week 3
measure: Feasibility as Assessed by the Number of Participants That Complete the Full tDCS Protocol
timeFrame: week 3
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:
citation: Martorella G, Mathis K, Miao H, Wang D, Park L, Ahn H. Self-administered transcranial direct current stimulation for pain in older adults with knee osteoarthritis: A randomized controlled study. Brain Stimul. 2022 Jul-Aug;15(4):902-909. doi: 10.1016/j.brs.2022.06.003. Epub 2022 Jun 8.