Brain Stimulation and Meditation for Pain After Total Knee Arthroplasty

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

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

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: active tDCS paired with active MBM; Device: sham tDCS paired with sham MBM

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Geraldine Martorella, PhD; Phone Number: 904-735-4961; Email: gmartorella@fsu.edu
• Study Contact Backup: Name: Katharine Lewis; Email: kag14e@fsu.edu

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32308
      • Recruiting
      • Tallahassee Orthopedic Clinic
      • Contact: Phillip Worts, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
numerical rating scale (NRS)	The NRS total score ranges from 0 (no pain) to 100 (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.	day 3 after surgery
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
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
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
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

Collaborators and Investigators

• Sponsor: Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): May 15, 2024
• Study Completion (Estimated): June 15, 2024

Study Registration Dates

• First Submitted: December 19, 2022
• First Submitted That Met QC Criteria: January 4, 2023
• First Posted (Actual): January 6, 2023

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 00003476; 140009-140 (Other Grant/Funding Number: Florida State University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes