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| ID | Type | Description | Link |
|---|---|---|---|
| 140009-140 | Other Grant/Funding Number | Florida State University |
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Feasibility, acceptability, and preliminary efficacy of combined transcranial direct current stimulation and mindfulness for pain after total knee arthroplasty
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| preoperative active tDCS+MBI | Experimental | Active tDCS with simultaneous meditation intervention will be applied. |
|
| preoperative sham tDCS+MBI | Sham Comparator | Sham tDCS with simultaneous sham MBM intervention will be delivered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active tDCS paired with active MBM | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale (NRS) | The NRS total score ranges from 0 (no pain) to 10 (most intense pain imaginable). | day 3 after surgery |
| Brief Pain Inventory (BPI) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tallahassee Orthopedic Clinic | Tallahassee | Florida | 32308 | United States |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Preoperative Active tDCS+MBI | Active tDCS with simultaneous meditation intervention will be applied for 20 minutes X 5 sessions. |
| FG001 | Preoperative Sham tDCS+MBI | Sham tDCS with simultaneous sham MBM intervention will be delivered for 20 minutes X 5 sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Preoperative Active tDCS+MBI | Active tDCS with simultaneous meditation intervention will be applied. |
| BG001 | Preoperative Sham tDCS+MBI | Sham tDCS with simultaneous sham MBM intervention will be delivered. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | age |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | mg | day 3 after surgery |
|
from baseline up to one month
questionnaire after each session + self-report to research assistant during study regarding serious and adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Preoperative Active tDCS+MBI | Active tDCS with simultaneous meditation intervention will be applied. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| tingling | Skin and subcutaneous tissue disorders | Systematic Assessment |
we had fNIRS malfunction at the beginning of the study and did not include cortical activity as an outcome in this study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Geraldine Martorella, Hyochol Ahn | Florida State University | 850-645-9758 | gmartorella@fsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 7, 2023 | Oct 10, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 10, 2025 | Nov 12, 2025 | SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 19, 2023 | Oct 25, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| sham tDCS paired with sham MBM | Device | 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. |
|
| day 3 after surgery |
| Patient Health Questionnaire-4 (PHQ-4) | 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 | day 3 after surgery |
| Pain Catastrophizing Scale (PCS) | 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. | day 3 after surgery |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | Numerical Rating Scale (NRS) | The NRS total score ranges from 0 (no pain) to 10 (most intense pain imaginable). | Posted | Mean | Standard Deviation | units on a scale | day 3 after surgery |
|
|
|
| Secondary | Brief Pain Inventory (BPI) | 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. | Posted | Mean | Standard Deviation | units on a scale | day 3 after surgery |
|
|
|
| Secondary | Patient Health Questionnaire-4 (PHQ-4) | 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 | Posted | Mean | Standard Deviation | units on a scale | day 3 after surgery |
|
|
|
| Secondary | Pain Catastrophizing Scale (PCS) | 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. | Posted | Mean | Standard Deviation | units on a scale | day 3 after surgery |
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|
| 0 |
| 12 |
| 0 |
| 12 |
| 4 |
| 12 |
| EG001 | Preoperative Sham tDCS+MBI | Sham tDCS with simultaneous sham MBM intervention will be delivered. | 0 | 12 | 0 | 12 | 4 | 12 |
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| D012216 |
| Rheumatic Diseases |