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

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ClinicalTrials.gov Identifier: NCT03884374
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Florida

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: Breathing and Attention Training (BAT) Behavioral: Sham Breathing and Attention Training (BAT) Device: Transcranial Direct Current Stimulation (tDCS) Device: Sham Transcranial Direct Current Stimulation (tDCS) Not Applicable

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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 randonmized to one of four conditions created by crossing Real tDCS vs. Sham tDCS with Real BAT vs. Sham 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)
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : June 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: African American Group
African Americans with knee osteoarthritis (OA).
Behavioral: Breathing and Attention Training (BAT)
Participants will receive mindfulness-based mental training regimen to independently practice mindfulness meditation.

Behavioral: Sham Breathing and Attention Training (BAT)
Sham-BAT intervention will incorporate most of the general aspects of the 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: Breathing and Attention Training (BAT)
Participants will receive mindfulness-based mental training regimen to independently practice mindfulness meditation.

Behavioral: Sham Breathing and Attention Training (BAT)
Sham-BAT intervention will incorporate most of the general aspects of the 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.




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'



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884374


Contacts
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Contact: Eric Weber 352-273-7802 eweber@dental.ufl.edu
Contact: Maria Aguirre, MPH 352-273-7620 maguirre@dental.ufl.edu

Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Florida
Department of Community Dentistry and Behavioral Science
Gainesville, Florida, United States, 32603
McKnight Brain Institute of the University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Roger Fillingim University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03884374     History of Changes
Other Study ID Numbers: IRB201900232 -N
R37AG033906 ( U.S. NIH Grant/Contract )
OCR20408 ( Other Identifier: UF OnCore )
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases