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NCT03884374 · ClinicalTrials.gov registry record · NA

Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)

A NA study, sponsored by University of Florida.

Completed
Registry status
NA
Development phase
317
Enrollment target

NCT03884374: Completed NA study, sponsored by University of Florida.

NCT03884374 is a NA study that has completed, run by University of Florida. The registered enrollment target is 317 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03884374, a NA study, has completed, sponsored by University of Florida.

COMPLETED
Registry status
NA
Development phase
317 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • DEVICE Transcranial Direct Current Stimulation (tDCS)
  • DEVICE Sham Transcranial Direct Current Stimulation (tDCS)
  • BEHAVIORAL Focused Breathing and Attention Training (BAT)
  • BEHAVIORAL Standard Breathing and Attention Training (BAT)

Trial Details

FieldValue
Enrollment Target 317 participants
Start Date 2020-03-13
Est. Completion 2025-02-28
Phase NA
University of Florida

1,106 total trials

What the finished NCT03884374 record still lists

NCT03884374 is an interventional study that assigns participants to a tested intervention. The registered 317 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 4 interventions - of which Transcranial Direct Current Stimulation (tDCS) is the first listed.

NCT03884374 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03884374 about?

NCT03884374 is a clinical study titled "Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)". 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 os...

What is the current status of trial NCT03884374?

This trial is currently completed. It is a NA study. The enrollment target is 317 participants. The study started on 2020-03-13. Estimated completion is 2025-02-28.

What interventions are being tested in trial NCT03884374?

The interventions under investigation include: Transcranial Direct Current Stimulation (tDCS) (DEVICE), Sham Transcranial Direct Current Stimulation (tDCS) (DEVICE), Focused Breathing and Attention Training (BAT) (BEHAVIORAL), Standard Breathing and Attention Training (BAT) (BEHAVIORAL).

Who is sponsoring clinical trial NCT03884374?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03884374's enrollment target sits among peer trials

317 321st of 2000 higher than 1,680 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03884374, the US trial registry maintained by the National Library of Medicine. NCT03884374 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.