Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03884374
Other study ID # IRB201900232 -N
Secondary ID R37AG033906OCR20
Status Recruiting
Phase N/A
First received
Last updated
Start date March 13, 2020
Est. completion date February 28, 2025

Study information

Verified date May 2024
Source University of Florida
Contact Eric Weber
Phone 352-273-7802
Email eweber@dental.ufl.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This mechanistic clinical trial proposes to test whether a five-day course of mindfulness meditation training (MMT) and tDCS, and their combination, can enhance pain modulatory balance and pain-related brain function, reduce clinical pain, among African Americans and non-Hispanic whites with knee osteoarthritis (OA). This approach will provide evidence that targeting stress and pain-related brain function will reduce OA-related pain and ethnic group differences therein.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date February 28, 2025
Est. primary completion date February 28, 2025
Accepts healthy volunteers No
Gender All
Age group 45 Years to 85 Years
Eligibility Inclusion Criteria: - Unilateral or bilateral symptomatic knee OA based on American College of Rheumatology Clinical criteria - Participant reports primary ethnic/race group as either African American or non-Hispanic white Exclusion Criteria: - Actively symptomatic systemic rheumatic disease/condition (e.g. rheumatoid arthritis, systemic lupus erythematosus), or fibromyalgia that results in pain outside the knee that is equal to or worse than the participant's knee pain. - A history of clinically significant surgery to the index knee. - Daily use of opioids. We will exclude patients using opioids daily as both continued use and temporary withdrawal from these medications this could affect pain perception and response to interventions. Other medications being used will be recorded and controlled in statistical analyses as needed. - Use of some centrally acting sodium channel blockers, calcium channel blockers and NMDA receptor antagonists, because some of these medications can block tDCS effects. Other medications can potentially influence response to tDCS (e.g. SSRIs, beta-blockers); therefore, consistent with recent recommendations (2), we will assess use of these medications and include them as covariates in our statistical models. - Uncontrolled hypertension (i.e. SBP/DBP of > 150/95) or unstable or activity limiting cardiovascular or peripheral arterial disease. These exclusions are in place primarily for safety reasons, because the cold pressor task represents a cardiovascular challenge. However, uncontrolled hypertension can also affect pain perception, which is another reason for excluding these individuals. - Neurological disease (e.g. Parkinson's, multiple sclerosis, epilepsy) or evidence of previous brain injury, including stroke and traumatic brain injury. - Serious psychiatric disorder requiring hospitalization within the past 12 months or characterized by active suicidal ideation. - Current substance use disorder or history of hospitalization for treatment of substance use disorder. - Diminished cognitive function that would interfere with understanding of study procedures.

Study Design


Intervention

Behavioral:
Focused Breathing and Attention Training (BAT)
Participants will receive mindfulness-based mental training regimen to independently practice mindfulness meditation.
Standard Breathing and Attention Training (BAT)
Standard BAT intervention will incorporate most of the general aspects of the Focused BAT intervention but without the specific instructions related to mindfully attending to the breath in a non-evaluative manner.
Device:
Transcranial Direct Current Stimulation (tDCS)
A Soterix 1x1 Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0mA direct current through two bicarbon rubber electrodes encased in saline-soaked sponges
Sham Transcranial Direct Current Stimulation (tDCS)
Sham stimulation procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA (30s ramp up/down) of stimulation at the beginning of the session.

Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama
United States University of Florida Gainesville Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Florida National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). 26 question index to assess knee OA pain; ranked from 'no pain' to 'extreme pain' Baseline; Day 1; Day 2; Day 3; Day 4; Day 5
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03274713 - Efficacy of Electro-acupuncture Versus Manual Acupuncture on Knee Osteoarthritis N/A
Completed NCT04535596 - Blood Flow Restriction Exercises and Conservative Exercises in Knee Osteoarthritis N/A
Completed NCT03918291 - Whole-body Vibration Training on Functional Performance of the Elderly With Knee Osteoarthritis N/A
Recruiting NCT06263517 - Clinical Trial to Assess Efficacy, Tolerability of Rising Doses of Clodronate in Painful Knee Osteoarthritis Patients Phase 2/Phase 3
Completed NCT01453738 - Allogeneic Mesenchymal Stem Cells in Osteoarthritis Phase 2
Active, not recruiting NCT01027819 - Comparison of Outcomes in Mobile and Fixed-bearing Total Knee Arthroplasty Phase 4
Completed NCT01186211 - Feasibility of Outpatient Total Knee Arthroplasty
Active, not recruiting NCT00261066 - Outcome Following Orthopaedic Surgery
Completed NCT03484910 - Biofeedback With Cycling Exercise in OA Knee Patients N/A
Completed NCT03492320 - Progression of Health Related Quality of Life of Patients Waiting for Total Knee Arthroplasty
Completed NCT01449552 - Temporary Clamping of Drains Combined With Tranexamic Acid Reduce Blood Loss After TKA: A Prospective RCT N/A
Completed NCT06254976 - Serum Nesfatin-1 and Human Cartilage Glycoprotein-39 Levels in Knee Osteoarthritis N/A
Completed NCT03428893 - Mobile Technology to Support Physical Therapy Exercise N/A
Completed NCT05081921 - Clinical Trial to Evaluate Safety and Efficacy of MesoCellA-Ortho Tissue-Engineered Advanced Therapy Product in Patients With Osteoarthrosis and Civilisation Diseases Phase 1/Phase 2
Completed NCT02850068 - Geniculate Artery Embolization for the Treatment of Knee Pain N/A
Active, not recruiting NCT03110172 - Short-term Efficacy of Antidepressant in Patients Underwent TKA Phase 1/Phase 2
Enrolling by invitation NCT02623660 - Microcurrent Stimulation Reduces Post-Operative Swelling and Healing Time Following Knee Replacement Surgery N/A
Completed NCT02579174 - Total Knee Replacement Component Alignment Using Manual Versus Custom Instrumentation N/A
Completed NCT00790985 - Efficacy of Flavocoxid 500 mg Compared With Naproxen 500 mg in Subjects With Moderate-severe Osteoarthritis of the Knee N/A
Recruiting NCT02722772 - Efficacy of Intra-Articular Injection of Etanercept for Moderate and Severe Knee Osteoarthritis N/A