NCT05673720

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 24, 2025

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

1.4 years

First QC Date

December 19, 2022

Results QC Date

October 15, 2025

Last Update Submit

November 12, 2025

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

  • Analgesic Consumption

    The dose of every opioid received within 3 days postoperatively will be transcribed and converted into standardized parenteral morphine equivalents using the Centers for Disease and Control Prevention Guidelines on opioids. A total in milligrams will be calculated for each day and means will be obtained for all groups.

    day 3 after surgery

Secondary Outcomes (4)

  • Numerical Rating Scale (NRS)

    day 3 after surgery

  • Brief Pain Inventory (BPI)

    day 3 after surgery

  • Patient Health Questionnaire-4 (PHQ-4)

    day 3 after surgery

  • Pain Catastrophizing Scale (PCS)

    day 3 after surgery

Study Arms (2)

preoperative active tDCS+MBI

EXPERIMENTAL

Active tDCS with simultaneous meditation intervention will be applied.

Device: active tDCS paired with active MBM

preoperative sham tDCS+MBI

SHAM COMPARATOR

Sham tDCS with simultaneous sham MBM intervention will be delivered.

Device: sham tDCS paired with sham MBM

Interventions

active tDCS paired with active MBMDEVICE

Active tDCS with a constant current intensity of 2 milli ampere( mA)will be applied for 20 minutes per session for 5 times via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session for 5 times by a recorded meditation.

preoperative active tDCS+MBI
sham tDCS paired with sham MBMDEVICE

For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM.

preoperative sham tDCS+MBI

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tallahassee Orthopedic Clinic

Tallahassee, Florida, 32308, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Limitations and Caveats

we had fNIRS malfunction at the beginning of the study and did not include cortical activity as an outcome in this study

Results Point of Contact

Title
Geraldine Martorella, Hyochol Ahn
Organization
Florida State University
gmartorella@fsu.edu
850-645-9758

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 19, 2022

First Posted

January 6, 2023

Study Start

May 15, 2023

Primary Completion

September 25, 2024

Study Completion

October 25, 2024

Last Updated

November 24, 2025

Results First Posted

November 24, 2025

Record last verified: 2025-11

Locations

US(1)