Brain Stimulation and Meditation for Pain After Total Knee Arthroplasty

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Device: sham tDCS paired with sham MBM; Device: active tDCS paired with active MBM

• Registration Number: NCT05673720
• Lead Sponsor: Florida State University

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.

Study Timeline

• Study First Submitted: 2022-12-19
• Study First Submitted QC: 2023-01-04
• Study First Posted: 2023-01-06
• Study Start: 2023-05-15
• Primary Completion: 2024-09-25
• Status Verified: 2024-10
• Study Completion: 2024-10-25
• Last Update Submitted: 2024-10-25
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
preoperative sham tDCS+MBI	sham tDCS paired with sham MBM	Sham tDCS with simultaneous sham MBM intervention will be delivered.
preoperative active tDCS+MBI	active tDCS paired with active MBM	Active tDCS with simultaneous meditation intervention will be applied.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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).

Trial Locations

Locations (1)

Tallahassee Orthopedic Clinic; 🇺🇸 Tallahassee, Florida, United States