Pain Relief for OsteoArthritis Through Combined Treatment (PROACT) (PROACT)

• ClinicalTrials.gov Identifier: NCT03884374
• Recruitment Status: Recruiting
• First Posted: March 21, 2019
• Last Update Posted: May 12, 2021
• Sponsor: University of Florida
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): University of Florida

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis of Knee	Behavioral: Focused Breathing and Attention Training (BAT); Behavioral: Standard Breathing and Attention Training (BAT); Device: Transcranial Direct Current Stimulation (tDCS); Device: Sham Transcranial Direct Current Stimulation (tDCS)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention Model Description: Adults (half AA, half NHW) with knee OA will be randomized to one of four conditions created by crossing Real tDCS vs. Sham tDCS with Focused BAT vs. Standard BAT
• Masking: Double (Participant, Investigator)
• Masking Description: Participants will be block randomized with stratification for site, sex, and race in double blind fashion.
• Primary Purpose: Treatment
• Official Title: Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)
• Actual Study Start Date: March 13, 2020
• Estimated Primary Completion Date: June 1, 2025
• Estimated Study Completion Date: June 1, 2027

Arms and Interventions

Arm	Intervention/treatment
Experimental: African American Group; African Americans with knee osteoarthritis (OA).	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; Other Name: Soterix 1x1 Clinical Trials Direct Current Stimulator; 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.
Experimental: Non-Hispanic White Group; Non-Hispanic whites with knee osteoarthritis (OA).	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; Other Name: Soterix 1x1 Clinical Trials Direct Current Stimulator; 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.

Outcome Measures

Primary Outcome Measures :

1. Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). [ Time Frame: Baseline; Day 1; Day 2; Day 3; Day 4; Day 5 ]
   26 question index to assess knee OA pain; ranked from 'no pain' to 'extreme pain'

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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:

• Systemic rheumatic disease/condition (e.g. rheumatoid arthritis, systemic lupus erythematosus, fibromyalgia).
• A history of clinically significant surgery to the index knee.
• Daily use of opioids. Patients using opioids daily as both continued use and temporary withdrawal from these medications this could affect pain perception and response to interventions will be excluded. Other medications being used will be recorded and controlled in statistical analyses as needed.
• Use of sodium channel blockers, calcium channel blockers and NMDA receptor antagonists, because these medications can block tDCS effects. Other medications can potentially influence response to tDCS (e.g. SSRIs, beta-blockers); therefore, consistent with recent recommendations, the investigators will assess use of these medications and include them as covariates in our statistical models.
• Uncontrolled hypertension (i.e. SBP/DBP of > 150/95), 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.
• Presence of non-removable magnetic material or devices (e.g. pacemakers, aneurism clips) or claustrophobia, which could pose a risk for injury in the MRI scanner

Contacts and Locations

Contacts

Contact: Eric Weber; 352-273-7802; eweber@dental.ufl.edu

Contact: Maria Aguirre, MPH; 352-273-7620; maguirre@dental.ufl.edu

Locations

United States, Alabama

University of Alabama at Birmingham; Recruiting

Birmingham, Alabama, United States, 35294

United States, Florida

University of Florida; Recruiting

Gainesville, Florida, United States, 32610

Contact: Eric o Weber 352-273-7802 eweber@dental.ufl.edu

Contact: Maria Aguirre

Sponsors and Collaborators

University of Florida

National Institute on Aging (NIA)

Investigators

• Principal Investigator: Roger Fillingim; University of Florida

More Information

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT03884374
• Other Study ID Numbers: IRB201900232 -N; R37AG033906 ( U.S. NIH Grant/Contract ); OCR20408 ( Other Identifier: UF OnCore )
• First Posted: March 21, 2019
• Last Update Posted: May 12, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases