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

Primary Purpose

Osteoarthritis of Knee

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Focused Breathing and Attention Training (BAT)

Standard Breathing and Attention Training (BAT)

Transcranial Direct Current Stimulation (tDCS)

Sham Transcranial Direct Current Stimulation (tDCS)

About this trial

This is an interventional treatment trial for Osteoarthritis of Knee

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Actively symptomatic systemic rheumatic disease/condition (e.g. rheumatoid arthritis, systemic lupus erythematosus), or fibromyalgia that results in pain outside the knee that is equal to or worse than the participant's knee pain.
A history of clinically significant surgery to the index knee.
Daily use of opioids. We will exclude patients using opioids daily as both continued use and temporary withdrawal from these medications this could affect pain perception and response to interventions. Other medications being used will be recorded and controlled in statistical analyses as needed.
Use of some centrally acting sodium channel blockers, calcium channel blockers and NMDA receptor antagonists, because some of these medications can block tDCS effects. Other medications can potentially influence response to tDCS (e.g. SSRIs, beta-blockers); therefore, consistent with recent recommendations (2), we will assess use of these medications and include them as covariates in our statistical models.
Uncontrolled hypertension (i.e. SBP/DBP of > 150/95) or unstable or activity limiting 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.

Sites / Locations

University of Alabama at BirminghamRecruiting
University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

African American Group

Non-Hispanic White Group

Arm Description

African Americans with knee osteoarthritis (OA).

Non-Hispanic whites with knee osteoarthritis (OA).

Outcomes

Primary Outcome Measures

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

26 question index to assess knee OA pain; ranked from 'no pain' to 'extreme pain'

Secondary Outcome Measures

Full Information

NCT ID

NCT03884374

First Posted

March 19, 2019

Last Updated

September 18, 2023

Sponsor

University of Florida

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT03884374

Brief Title

Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)

Acronym

PROACT

Official Title

Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 13, 2020 (Actual)

Primary Completion Date

February 29, 2024 (Anticipated)

Study Completion Date

February 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

Collaborators

National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis of Knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

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

ParticipantInvestigator

Masking Description

Participants will be block randomized with stratification for site, sex, and race in double blind fashion.

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

African American Group

Arm Type

Experimental

Arm Description

African Americans with knee osteoarthritis (OA).

Arm Title

Non-Hispanic White Group

Arm Type

Experimental

Arm Description

Non-Hispanic whites with knee osteoarthritis (OA).

Intervention Type

Behavioral

Intervention Name(s)

Focused Breathing and Attention Training (BAT)

Intervention Description

Participants will receive mindfulness-based mental training regimen to independently practice mindfulness meditation.

Intervention Type

Behavioral

Intervention Name(s)

Standard Breathing and Attention Training (BAT)

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Transcranial Direct Current Stimulation (tDCS)

Other Intervention Name(s)

Soterix 1x1 Clinical Trials Direct Current Stimulator

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Sham Transcranial Direct Current Stimulation (tDCS)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

Description

26 question index to assess knee OA pain; ranked from 'no pain' to 'extreme pain'

Time Frame

Baseline; Day 1; Day 2; Day 3; Day 4; Day 5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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: Actively symptomatic systemic rheumatic disease/condition (e.g. rheumatoid arthritis, systemic lupus erythematosus), or fibromyalgia that results in pain outside the knee that is equal to or worse than the participant's knee pain. A history of clinically significant surgery to the index knee. Daily use of opioids. We will exclude patients using opioids daily as both continued use and temporary withdrawal from these medications this could affect pain perception and response to interventions. Other medications being used will be recorded and controlled in statistical analyses as needed. Use of some centrally acting sodium channel blockers, calcium channel blockers and NMDA receptor antagonists, because some of these medications can block tDCS effects. Other medications can potentially influence response to tDCS (e.g. SSRIs, beta-blockers); therefore, consistent with recent recommendations (2), we will assess use of these medications and include them as covariates in our statistical models. Uncontrolled hypertension (i.e. SBP/DBP of > 150/95) or unstable or activity limiting 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eric Weber

Phone

352-273-7802

eweber@dental.ufl.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Julie Siegrist

Phone

352-273-5964

juliesiegrist@ufl.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roger Fillingim

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Individual Site Status

Recruiting

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eric Weber

Phone

352-273-7802

eweber@dental.ufl.edu

First Name & Middle Initial & Last Name & Degree

Julie Siegrist

Phone

352-273-5964

juliesiegrist@ufl.edu

12. IPD Sharing Statement

Plan to Share IPD

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Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)

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