Trial Outcomes & Findings for Brain Stimulation and Meditation for Pain After Total Knee Arthroplasty (NCT NCT05673720)
NCT ID: NCT05673720
Last Updated: 2025-11-24
Results Overview
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.
COMPLETED
NA
24 participants
day 3 after surgery
2025-11-24
Participant Flow
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.
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.
Participant milestones
| Measure |
Preoperative Active tDCS+MBI
Active tDCS with simultaneous meditation intervention will be applied for 20 minutes X 5 sessions.
|
Preoperative Sham tDCS+MBI
Sham tDCS with simultaneous sham MBM intervention will be delivered for 20 minutes X 5 sessions.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brain Stimulation and Meditation for Pain After Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Preoperative Active tDCS+MBI
n=12 Participants
Active tDCS with simultaneous meditation intervention will be applied.
|
Preoperative Sham tDCS+MBI
n=12 Participants
Sham tDCS with simultaneous sham MBM intervention will be delivered.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.4 years
STANDARD_DEVIATION 9.7 • n=45 Participants
|
67.1 years
STANDARD_DEVIATION 9.3 • n=12929 Participants
|
67.3 years
STANDARD_DEVIATION 9.4 • n=6349 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=45 Participants
|
7 Participants
n=12929 Participants
|
15 Participants
n=6349 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=45 Participants
|
5 Participants
n=12929 Participants
|
9 Participants
n=6349 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=45 Participants
|
12 Participants
n=12929 Participants
|
24 Participants
n=6349 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
4 Participants
n=6349 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=45 Participants
|
11 Participants
n=12929 Participants
|
19 Participants
n=6349 Participants
|
|
Race/Ethnicity, Customized
multiple ethnicity
|
1 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
PRIMARY outcome
Timeframe: day 3 after surgeryThe 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.
Outcome measures
| Measure |
Preoperative Active tDCS+MBI
n=12 Participants
Active tDCS with simultaneous meditation intervention will be applied.
|
Preoperative Sham tDCS+MBI
n=12 Participants
Sham tDCS with simultaneous sham MBM intervention will be delivered.
|
|---|---|---|
|
Analgesic Consumption
|
0 mg
Standard Deviation 0
|
0 mg
Standard Deviation 0
|
SECONDARY outcome
Timeframe: day 3 after surgeryThe NRS total score ranges from 0 (no pain) to 10 (most intense pain imaginable).
Outcome measures
| Measure |
Preoperative Active tDCS+MBI
n=12 Participants
Active tDCS with simultaneous meditation intervention will be applied.
|
Preoperative Sham tDCS+MBI
n=12 Participants
Sham tDCS with simultaneous sham MBM intervention will be delivered.
|
|---|---|---|
|
Numerical Rating Scale (NRS)
|
6.18 units on a scale
Standard Deviation 1.40
|
5.71 units on a scale
Standard Deviation 2.56
|
SECONDARY outcome
Timeframe: day 3 after surgeryIt 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.
Outcome measures
| Measure |
Preoperative Active tDCS+MBI
n=12 Participants
Active tDCS with simultaneous meditation intervention will be applied.
|
Preoperative Sham tDCS+MBI
n=12 Participants
Sham tDCS with simultaneous sham MBM intervention will be delivered.
|
|---|---|---|
|
Brief Pain Inventory (BPI)
|
6.04 units on a scale
Standard Deviation 2.17
|
5.51 units on a scale
Standard Deviation 3.39
|
SECONDARY outcome
Timeframe: day 3 after surgeryThe 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
Outcome measures
| Measure |
Preoperative Active tDCS+MBI
n=12 Participants
Active tDCS with simultaneous meditation intervention will be applied.
|
Preoperative Sham tDCS+MBI
n=12 Participants
Sham tDCS with simultaneous sham MBM intervention will be delivered.
|
|---|---|---|
|
Patient Health Questionnaire-4 (PHQ-4)
|
5.4 units on a scale
Standard Deviation 2.76
|
8.0 units on a scale
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: day 3 after surgeryto 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.
Outcome measures
| Measure |
Preoperative Active tDCS+MBI
n=12 Participants
Active tDCS with simultaneous meditation intervention will be applied.
|
Preoperative Sham tDCS+MBI
n=12 Participants
Sham tDCS with simultaneous sham MBM intervention will be delivered.
|
|---|---|---|
|
Pain Catastrophizing Scale (PCS)
|
20.56 units on a scale
Standard Deviation 7.76
|
25.25 units on a scale
Standard Deviation 13.05
|
Adverse Events
Preoperative Active tDCS+MBI
Preoperative Sham tDCS+MBI
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Preoperative Active tDCS+MBI
n=12 participants at risk
Active tDCS with simultaneous meditation intervention will be applied.
|
Preoperative Sham tDCS+MBI
n=12 participants at risk
Sham tDCS with simultaneous sham MBM intervention will be delivered.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
tingling
|
33.3%
4/12 • Number of events 4 • from baseline up to one month
questionnaire after each session + self-report to research assistant during study regarding serious and adverse events
|
33.3%
4/12 • Number of events 4 • from baseline up to one month
questionnaire after each session + self-report to research assistant during study regarding serious and adverse events
|
Additional Information
Geraldine Martorella, Hyochol Ahn
Florida State University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place