Brain Stimulation and Meditation for Pain After Total Knee Arthroplasty

Florida State University

Status: Completed

Conditions: Osteoarthritis, Knee

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05673720

00003476

140009-140 (Other Grant/Funding Number)

Details and patient eligibility

About

Feasibility, acceptability, and preliminary efficacy of combined transcranial direct current stimulation and mindfulness for pain after total knee arthroplasty

Full description

The project is to assess the preliminary feasibility, acceptability, and efficacy of self-administered preoperative tDCS+MBI in older adults (50+) undergoing TKR. And to determine the effects of 5, 20-minute preoperative self-administered tDCS sessions combined with brief MBI on analgesic medication consumption following TKR.

Enrollment: 24 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• elective unilateral knee total replacement
• mentally capable of reading, giving consent and following instructions
• being able to answer questions in English
• not pregnant

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 and NMDS receptor antagonists
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

preoperative active tDCS+MBI

Experimental group

Description:

Active tDCS with simultaneous meditation intervention will be applied.

Treatment:

Device: active tDCS paired with active MBM

preoperative sham tDCS+MBI

Sham Comparator group

Description:

Sham tDCS with simultaneous sham MBM intervention will be delivered.

Treatment:

Device: sham tDCS paired with sham MBM