NCT03884374

Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 317 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis of Knee

Interventions

Type	Name	Description
BEHAVIORAL	Focused Breathing and Attention Training (BAT)	Participants will receive mindfulness-based mental training regimen to independently practice mindfulness meditation.
BEHAVIORAL	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
DEVICE	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.

Timeline

• Start date: 2020-03-13
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2019-03-21
• Last updated: 2025-08-15
• Results posted: 2025-08-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study