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NCT03884374: PROACT

Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)

Completed NA Results posted Last updated 15 August 2025
What this trial tests

NA trial testing Focused Breathing and Attention Training (BAT) in Osteoarthritis of Knee in 317 participants. Completed in 28 February 2025.

Timeline
13 March 2020
Primary endpoint
28 February 2025
28 February 2025

Quick facts

Lead sponsorUniversity of Florida
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designfactorial
Maskingdouble
Primary purposetreatment
Enrollment317
Start date13 March 2020
Primary completion28 February 2025
Estimated completion28 February 2025
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Florida

Who can join

Adults 45 to 85, any sex, with Osteoarthritis of Knee. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Primary · Visit 1-Baseline prior to intervention and Visit 7 which is about 1 month after baseline visit and study intervention.

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): 26 question index to assess knee OA pain (0-20 scale), function (0-68 scale), and stiffness (0-8 scale). The total WOAMC score is the sum of the 3 sub scales for a total score range from 0-96. Change in total WOMAC score = V7 total WOMAC score - Baseline (pre-intervention) total WOMAC score. The lower change scores represents improvement in pain, movement, and stiffness.

GroupValue95% CI
Sham/Sham-6.5± 11.3
Sham/Active-3.8± 13.5
Active/Sham-7.4± 12.1
Active/Active-6.3± 15

Adverse events — posted to ClinicalTrials.gov

Time frame: about 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Sham/Sham
Serious: 0/63 (0%)
Deaths: 0/63
Sham/Active
Serious: 0/61 (0%)
Deaths: 0/61
Active/Sham
Serious: 0/64 (0%)
Deaths: 0/64
Active/Active
Serious: 0/63 (0%)
Deaths: 0/63
Other adverse events (6 terms — click to expand)

ReactionSystemSham/ShamSham/ActiveActive/ShamActive/Active
HeadacheNervous system disorders
IrritationSkin and subcutaneous tissue disorders
PainNervous system disorders
Blurry visionEye disorders
Burning sensationSkin and subcutaneous tissue disorders
CrampingMusculoskeletal and connective tissue disorders

Data from ClinicalTrials.gov NCT03884374 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Stimulated brains and meditative minds: A systematic review on combining low intensity transcranial electrical stimulation and meditation in humans.
    Divarco R, Ramasawmy P, Petzke F, Antal A. · · 2023 · cited 16× · PMID 36817875 · DOI 10.1016/j.ijchp.2023.100369
  2. Pain relief for osteoarthritis through combined treatment (PROACT): Protocol for a randomized controlled trial of mindfulness meditation combined with transcranial direct current stimulation in non-Hispanic black and white adults with knee osteoarthritis.
    Fillingim RB, Woods AJ, Ahn H, Wu SS, et al · · 2020 · cited 10× · PMID 32992020 · DOI 10.1016/j.cct.2020.106159

Verify or expand the search:

Other recruiting trials for Osteoarthritis of Knee

Currently open trials in the same condition.

Other University of Florida trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03884374.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing