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Brain Stimulation and Meditation for Pain After Total Knee Arthroplasty
NA trial testing active tDCS paired with active MBM in Osteoarthritis, Knee in 24 participants. Completed in 25 October 2024.
| Lead sponsor | Florida State University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 15 May 2023 |
| Primary completion | 25 September 2024 |
| Estimated completion | 25 October 2024 |
| Sites | 1 location across United States |
Florida State University
Adults 50 to 85, any sex, with Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Preoperative Active tDCS+MBI | 0 | ± 0 |
| Preoperative Sham tDCS+MBI | 0 | ± 0 |
The NRS total score ranges from 0 (no pain) to 10 (most intense pain imaginable).
| Group | Value | 95% CI |
|---|---|---|
| Preoperative Active tDCS+MBI | 6.18 | ± 1.40 |
| Preoperative Sham tDCS+MBI | 5.71 | ± 2.56 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Preoperative Active tDCS+MBI | 6.04 | ± 2.17 |
| Preoperative Sham tDCS+MBI | 5.51 | ± 3.39 |
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
| Group | Value | 95% CI |
|---|---|---|
| Preoperative Active tDCS+MBI | 5.4 | ± 2.76 |
| Preoperative Sham tDCS+MBI | 8.0 | ± 3.6 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Preoperative Active tDCS+MBI | 20.56 | ± 7.76 |
| Preoperative Sham tDCS+MBI | 25.25 | ± 13.05 |
Time frame: from baseline up to one month. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Preoperative Active tDCS+MBI | Preoperative Sham tDCS+MBI |
|---|---|---|---|
| tingling | Skin and subcutaneous tissue disorders | — | — |
Data from ClinicalTrials.gov NCT05673720 adverse events section.
Feasibility, acceptability, and preliminary efficacy of combined transcranial direct current stimulation and mindfulness for pain after total knee arthroplasty
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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