Brain Stimulation and Meditation for Pain After Total Knee Arthroplasty
Study Details
Study Description
Brief Summary
Feasibility, acceptability, and preliminary efficacy of combined transcranial direct current stimulation and mindfulness for pain after total knee arthroplasty
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: preoperative active tDCS+MBI Active tDCS with simultaneous meditation intervention will be applied. |
Device: active 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.
|
| Sham Comparator: preoperative sham tDCS+MBI Sham tDCS with simultaneous sham MBM intervention will be delivered. |
Device: sham 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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- numerical rating scale (NRS) [day 3 after surgery]
The NRS total score ranges from 0 (no pain) to 100 (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.
- Patient Health Questionnaire-4 (PHQ-4) [day 3 after surgery]
with regards to emotional function, considering established relations between pain, anxiety, and depression, measures of anxiety and depression will be taken
- 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).
- Change in pain related cortical response using a continuous wave, multichannel Functional near-infrared spectroscopy (fNIRS) imaging system [change from baseline at day 5 of intervention]
Pain-related cortical response will be measured using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) with three semiconductor lasers at 780, 805, and 830 nm. Optical recordings will be collected during thermal pain stimulation.
- Change in descending pain modulation (CPM) as measured by the quantitative sensory testing [change from baseline at day 5 of intervention]
Descending pain modulation will be determined by the change in pressure pain threshold on the trapezius immediately after the immersion of the contralateral hand up to the wrist in a cold water bath at 12°C for one minute, with higher CPM scores indicating better descending pain modulation. Descending pain modulation will be reflected by an increase in pressure pain threshold after cold water immersion.
Eligibility Criteria
Criteria
Inclusion Criteria:
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elective unilateral knee total replacement
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mentally capable of reading, giving consent and following instructions
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being able to answer questions in English
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not pregnant
Exclusion Criteria:
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history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation
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systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia
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alcohol/substance abuse
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current use of sodium channel blockers, calcium channel blockers and NMDS receptor antagonists
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hospitalization within the preceding year for psychiatric illness
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no access to a device with internet access that can be used for secure videoconferencing for real-time remote supervision
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Florida State University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 00003476
- 140009-140