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Mindfulness + tDCS for Osteoarthritis (PROACT Trial)

N/A
Recruiting
Led By Roger Fillingim
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unilateral or bilateral symptomatic knee OA based on American College of Rheumatology Clinical criteria
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; day 1; day 2; day 3; day 4; day 5
Awards & highlights

PROACT Trial Summary

This trial will test whether mindfulness meditation and transcranial direct current stimulation (tDCS) can reduce pain for people with knee osteoarthritis, especially among African Americans and non-Hispanic whites.

Who is the study for?
This trial is for African American or non-Hispanic white adults with knee osteoarthritis, as per the American College of Rheumatology criteria. Excluded are those with significant knee surgery history, uncontrolled hypertension, substance use disorders, daily opioid use, serious psychiatric conditions in the past year, other painful rheumatic diseases or fibromyalgia, and certain neurological conditions.Check my eligibility
What is being tested?
The PROACT study tests if mindfulness meditation training (MMT), Transcranial Direct Current Stimulation (tDCS), their combination or a sham procedure can improve pain management and brain function related to pain in people with knee osteoarthritis over five days.See study design
What are the potential side effects?
Potential side effects from tDCS may include mild tingling, itching or discomfort at the electrode site on the scalp during stimulation. Mindfulness meditation is generally considered safe but could potentially cause emotional discomfort when dealing with thoughts and sensations.

PROACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have knee pain diagnosed as osteoarthritis by a doctor.

PROACT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; day 1; day 2; day 3; day 4; day 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; day 1; day 2; day 3; day 4; day 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

Side effects data

From 2018 Phase 2 trial • 54 Patients • NCT01726673
3%
back pain flair up
3%
Myasthenia Gravis
100%
80%
60%
40%
20%
0%
Study treatment Arm
tDCS + Robotic Arm Therapy
tDCS Sham + Robotic Arm Therapy

PROACT Trial Design

2Treatment groups
Experimental Treatment
Group I: Non-Hispanic White GroupExperimental Treatment4 Interventions
Non-Hispanic whites with knee osteoarthritis (OA).
Group II: African American GroupExperimental Treatment4 Interventions
African Americans with knee osteoarthritis (OA).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sham Transcranial Direct Current Stimulation (tDCS)
2021
N/A
~190
Transcranial Direct Current Stimulation (tDCS)
2016
Completed Phase 2
~2100

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,016,823 Total Patients Enrolled
29 Trials studying Osteoarthritis
9,818 Patients Enrolled for Osteoarthritis
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,465 Total Patients Enrolled
14 Trials studying Osteoarthritis
10,895 Patients Enrolled for Osteoarthritis
Roger FillingimPrincipal InvestigatorUniversity of Florida

Media Library

Standard Breathing and Attention Training (BAT) Clinical Trial Eligibility Overview. Trial Name: NCT03884374 — N/A
Osteoarthritis Research Study Groups: Non-Hispanic White Group, African American Group
Osteoarthritis Clinical Trial 2023: Standard Breathing and Attention Training (BAT) Highlights & Side Effects. Trial Name: NCT03884374 — N/A
Standard Breathing and Attention Training (BAT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03884374 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment still open for this research endeavor?

"Affirmative. According to clinicaltrials.gov, this experiment which was initially posted on March 13th 2020 is actively searching for new participants and has been recently updated on September 15th 2022. The trial requires 240 individuals from 2 different medical facilities."

Answered by AI

Who meets the eligibility criteria for participation in this clinical trial?

"This medical trial is recruiting up to 240 individuals presenting with knee osteoarthritis between the ages of 45 and 85. Notably, candidates must satisfy American College of Rheumatology Clinical criteria as well as be identified as either African-American or non-Hispanic white in terms of their racial/ethnic background."

Answered by AI

How many volunteers are participating in this experiment?

"Affirmative. Clinicaltrials.gov data suggests this medical trial is actively seeking participants, with the original posting on March 13th 2020 and an edit made as recently as September 15th 2022. 240 patients are sought to partake between 2 separate sites."

Answered by AI

Is this research opportunity accessible to individuals who are younger than 30 years of age?

"Taking into account the conditions for participation, candidates must be aged between 45 and 85 to qualify."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
Florida
What site did they apply to?
University of Florida
University of Alabama at Birmingham
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)
2020. "Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03884374.
All > Oa
~47 spots leftby Apr 2025
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