Brain Stimulation and Meditation for Pain After Total Knee Arthroplasty

Osteoarthritis, Knee Clinical Trial

Official title:

Feasibility, Acceptability, and Preliminary Efficacy of Combined Transcranial Direct Current Stimulation and Mindfulness for Pain After Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05673720
• Other study ID #: 00003476
• Secondary ID: 140009-140
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: June 15, 2024

Study information

• Verified date: January 2024
• Source: Florida State University
• Contact: Geraldine Martorella, PhD
• Phone: 904-735-4961
• Email: gmartorella[@]fsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Feasibility, acceptability, and preliminary efficacy of combined transcranial direct current stimulation and mindfulness for pain after total knee arthroplasty

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

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 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.

Locations

Country	Name	City	State
United States	Tallahassee Orthopedic Clinic	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	day 3 after surgery
Secondary	numerical rating scale (NRS)	The NRS total score ranges from 0 (no pain) to 100 (most intense pain imaginable).	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.	day 3 after surgery
Secondary	Patient Health Questionnaire-4 (PHQ-4)	with regards to emotional function, considering established relations between pain, anxiety, and depression, measures of anxiety and depression will be taken	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).	day 3 after surgery
Secondary	Change in pain related cortical response using a continuous wave, multichannel Functional near-infrared spectroscopy (fNIRS) imaging system	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 from baseline at day 5 of intervention
Secondary	Change in descending pain modulation (CPM) as measured by the quantitative sensory testing	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.	change from baseline at day 5 of intervention