Brain Stimulation and Meditation for Pain After Total Knee Arthroplasty

Feasibility, Acceptability, and Preliminary Efficacy of Combined Transcranial Direct Current Stimulation and Mindfulness for Pain After Total Knee Arthroplasty

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05673720

Enrollment

Registered

2023-01-06

Start date

2023-05-15

Completion date

2024-10-25

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Brief summary

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

Detailed 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.

Interventions

DEVICEactive tDCS paired with active MBM

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.

DEVICEsham tDCS paired with sham MBM

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Analgesic Consumption	day 3 after surgery	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.

Secondary

Measure	Time frame	Description
Numerical Rating Scale (NRS)	day 3 after surgery	The NRS total score ranges from 0 (no pain) to 10 (most intense pain imaginable).
Brief Pain Inventory (BPI)	day 3 after surgery	It includes seven items and evaluates the impact of pain on general activity, mood, walking, work, relationships, sleep, and enjoyment of life via a NRS (0-10). Each item represents a subscale and can be scored and analyzed individually (0-10), with the anchors being does not interfere (0) and completely interferes (10). A total interference score can also be calculated by taking the sum of all the items (score range 0-70). A higher score reflects worse outcomes : higher pain interference with activities.
Patient Health Questionnaire-4 (PHQ-4)	day 3 after surgery	The PHQ-4 has a total score range of 0-12, which is broken down into four ranges: normal (0-2), mild (3-5), moderate (6-8), and severe (9-12) psychological distress. For the subscales (PHQ-2 for depression and GAD-2 for anxiety), the score range is 0-6. higher values represent a worse outcome
Pain Catastrophizing Scale (PCS)	day 3 after surgery	to assess patients' pain-related catastrophic thoughts. It includes 13 items divided into three subscales: rumination (4 items), magnification (3 items), and helplessness (6 items). Each item is rated on a 5-point scale with the end points not at all (score=0) and all the time (score=4). The total score range for the Pain Catastrophizing Scale (PCS) is 0 to 52, where a higher score indicates greater levels of pain catastrophizing.

Countries

United States

Participant flow

Recruitment details

May 2023 and February 2024. Participants were recruited at their preoperative visit. A clinician or a research coordinator from the clinic conducted a pre-screening of potentially eligible participants, and introduced the study to potential participants at their preoperative visit. If the individual agreed to learn more, the PI or RA entered the room to discuss study, answer questions and scheduled an appointment.

Pre-assignment details

A total of 40 potential participants were approached. Of these, 8 (20%) did not meet inclusion criteria (e.g., partial replacement surgery, fibromyalgia) and 8 declined to participated (20%) mainly because they were living too far to travel to the lab for the baseline and last appointments before surgery.

Participants by arm

Arm	Count
Preoperative Active tDCS+MBI Active tDCS with simultaneous meditation intervention will be applied.	12
Preoperative Sham tDCS+MBI Sham tDCS with simultaneous sham MBM intervention will be delivered.	12
Total	24

Baseline characteristics

Characteristic	Preoperative Active tDCS+MBI	Preoperative Sham tDCS+MBI	Total
Age, Continuous	67.4 years STANDARD_DEVIATION 9.7	67.1 years STANDARD_DEVIATION 9.3	67.3 years STANDARD_DEVIATION 9.4
Race/Ethnicity, Customized Black	3 Participants	1 Participants	4 Participants
Race/Ethnicity, Customized multiple ethnicity	1 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized White	8 Participants	11 Participants	19 Participants
Region of Enrollment United States	12 Participants	12 Participants	24 Participants
Sex: Female, Male Female	8 Participants	7 Participants	15 Participants
Sex: Female, Male Male	4 Participants	5 Participants	9 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 12	0 / 12
other Total, other adverse events	4 / 12	4 / 12
serious Total, serious adverse events	0 / 12	0 / 12

Outcome results

Primary

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.