Osteoarthritis of KneePROACTNCT03884374
Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)
A study testing Focused Breathing and Attention Training (BAT), Standard Breathing and Attention Training (BAT) and Transcranial Direct Current Stimulation (tDCS) in people with Osteoarthritis of Knee, run by University of Florida at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Osteoarthritis of Knee
- What is being tested?
- Focused Breathing and Attention Training (BAT), Standard Breathing and Attention Training (BAT) and Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 317 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Mar 2020to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Florida
Gainesville, Florida, 32610
About this study
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
- Being tested
- Focused Breathing and Attention Training (BAT), Standard Breathing and Attention Training (BAT), Transcranial Direct Current Stimulation (tDCS), Sham Transcranial Direct Current Stimulation (tDCS)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused Breathing and Attention Training (BAT)Behavioural
Participants will receive mindfulness-based mental training regimen to independently practice mindfulness meditation.
Standard Breathing and Attention Training (BAT)Behavioural
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.
Transcranial Direct Current Stimulation (tDCS)Device
Also called Soterix 1x1 Clinical Trials Direct Current Stimulator
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
Sham Transcranial Direct Current Stimulation (tDCS)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Sham/Sham | Experimental | 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.
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. Receives: Behavioral: Standard Breathing and Attention Training (BAT); Device: Sham Transcranial Direct Current Stimulation (tDCS) |
| Sham/Active | Experimental | 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.
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 Receives: Behavioral: Standard Breathing and Attention Training (BAT); Device: Transcranial Direct Current Stimulation (tDCS) |
| Active/Sham | Experimental | Focused Breathing and Attention Training (BAT): Participants will receive mindfulness-based mental training regimen to independently practice mindfulness meditation.
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. Receives: Behavioral: Focused Breathing and Attention Training (BAT); Device: Sham Transcranial Direct Current Stimulation (tDCS) |
| Active/Active | Experimental | Focused Breathing and Attention Training (BAT): Participants will receive mindfulness-based mental training regimen to independently practice mindfulness meditation.
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 Receives: Behavioral: Focused Breathing and Attention Training (BAT); Device: Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
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.
Measured: Visit 1-Baseline prior to intervention and Visit 7 which is about 1 month after baseline visit and study intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start13 Mar 2020
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis of KneeStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Roger Fillingim, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884374
- Sponsor's protocol ID
- IRB201900232 -N
- Other IDs
- R37AG033906, OCR20408
- Acronym
- PROACT
- Status last verified
- Jul 2025
- First submitted
- 19 Mar 2019
- Last updated
- 15 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)
- ClinicalTrials.gov ID
- NCT03884374
- Acronym / sponsor ID
- PROACT / IRB201900232 -N
- Conditions
- Osteoarthritis of Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Posted 15 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Sham/Sham | Experimental | Behavioral: Standard Breathing and Attention Training (BAT), Device: Sham Transcranial Direct Current Stimulation (tDCS)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. 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. |
| Sham/Active | Experimental | Behavioral: Standard Breathing and Attention Training (BAT), Device: Transcranial Direct Current Stimulation (tDCS)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. 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 |
| Active/Sham | Experimental | Behavioral: Focused Breathing and Attention Training (BAT), Device: Sham Transcranial Direct Current Stimulation (tDCS)Focused Breathing and Attention Training (BAT): Participants will receive mindfulness-based mental training regimen to independently practice mindfulness meditation. 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. |
| Active/Active | Experimental | Behavioral: Focused Breathing and Attention Training (BAT), Device: Transcranial Direct Current Stimulation (tDCS)Focused Breathing and Attention Training (BAT): Participants will receive mindfulness-based mental training regimen to independently practice mindfulness meditation. 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 |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focused Breathing and Attention Training (BAT)Participants will receive mindfulness-based mental training regimen to independently practice mindfulness meditation. | Behavioural | Active/Active, Active/Sham |
| 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. | Behavioural | Sham/Active, Sham/Sham |
| Transcranial Direct Current Stimulation (tDCS)Also: Soterix 1x1 Clinical Trials Direct Current StimulatorA 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 | Active/Active, Sham/Active |
| 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. | Device | Active/Sham, Sham/Sham |
Primary outcome
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Time frame: Visit 1-Baseline prior to intervention and Visit 7 which is about 1 month after baseline visit and study intervention.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Fillingim principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused Breathing and Attention Training (BAT), Standard Breathing and Attention Training (BAT) and Transcranial Direct Current Stimulation (tDCS) in people with Osteoarthritis of Knee, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). (time frame: Visit 1-Baseline prior to intervention and Visit 7 which is about 1 month after baseline visit and study intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.