Home-based tDCS and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms

University of Arizona

Status: Completed

Conditions: Osteo Arthritis Knee

Treatments: Device: sham tDCS paired with active MBM; Device: sham tDCS paired with sham MBM; Device: active tDCS paired with sham MBM; Device: active tDCS paired with active MBM

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04375072

R01NR019051-03S1 (U.S. NIH Grant/Contract)

R01NR019051 (U.S. NIH Grant/Contract)

STUDY00003164

Details and patient eligibility

About

This clinical trial aims to evaluate whether a 2 week regimen of transcranial direct current stimulation (tDCS) paired with mindfulness-based meditation (MBM) can improve pain modulation, reduce clinical pain, and alleviate osteoarthritis (OA)-related symptoms in patients with knee OA.

Enrollment: 208 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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208 participants in 4 patient groups

active tDCS paired with active MBM,

Experimental group

Treatment:

Device: active tDCS paired with active MBM

sham tDCS paired with active MBM

Active Comparator group

Treatment:

Device: sham tDCS paired with active MBM

active tDCS paired with sham MBM

Active Comparator group

Treatment:

Device: active tDCS paired with sham MBM

sham tDCS paired with sham MBM

Sham Comparator group

Treatment:

Device: sham tDCS paired with sham MBM