Osteoarthritis of Knee
Conditions
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.
Interventions
BEHAVIORALFocused Breathing and Attention Training (BAT)
Participants will receive mindfulness-based mental training regimen to independently practice mindfulness meditation.
BEHAVIORALStandard 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.
DEVICETranscranial 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
DEVICESham 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.
Sponsors
National Institute on Aging (NIA)
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants will be block randomized with stratification for site, sex, and race in double blind fashion.
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
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). | 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. |
Countries
United States
Participant flow
Pre-assignment details
317 signed consent and 251 were randomized to one of the 4 study arms. 66 people were found to be ineligible or chose not to be in the study. This is a result of additional screening being conducted after consent was obtained.
Participants by arm
| Arm | Count |
|---|---|
| Sham/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.
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.
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. | 63 |
| Sham/Active 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
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 | 61 |
| Active/Sham 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.
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. | 64 |
| Active/Active 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
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 | 63 |
| Total | 251 |
Baseline characteristics
| Characteristic | Sham/Sham | Sham/Active | Active/Sham | Active/Active | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 16 Participants | 28 Participants | 20 Participants | 82 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants | 45 Participants | 36 Participants | 43 Participants | 169 Participants |
| Age, Continuous | 60.8 Years STANDARD_DEVIATION 9.2 | 60.6 Years STANDARD_DEVIATION 8.9 | 63.4 Years STANDARD_DEVIATION 8.2 | 60.1 Years STANDARD_DEVIATION 9.3 | 61.2 Years STANDARD_DEVIATION 8.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 63 Participants | 61 Participants | 64 Participants | 63 Participants | 251 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 30 Participants | 31 Participants | 32 Participants | 33 Participants | 126 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 33 Participants | 30 Participants | 32 Participants | 30 Participants | 125 Participants |
| Region of Enrollment United States | 63 participants | 63 participants | 63 participants | 63 participants | 251 participants |
| Sex: Female, Male Female | 43 Participants | 39 Participants | 43 Participants | 43 Participants | 168 Participants |
| Sex: Female, Male Male | 20 Participants | 22 Participants | 21 Participants | 20 Participants | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 61 | 0 / 64 | 0 / 63 |
| other Total, other adverse events | 2 / 63 | 3 / 61 | 4 / 64 | 2 / 63 |
| serious Total, serious adverse events | 0 / 63 | 0 / 61 | 0 / 64 | 0 / 63 |
Outcome results
Primary
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.
Time frame: Visit 1-Baseline prior to intervention and Visit 7 which is about 1 month after baseline visit and study intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham/Sham | Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). | -6.5 units on a scale | Standard Deviation 11.3 |
| Sham/Active | Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). | -3.8 units on a scale | Standard Deviation 13.5 |
| Active/Sham | Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). | -7.4 units on a scale | Standard Deviation 12.1 |
| Active/Active | Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). | -6.3 units on a scale | Standard Deviation 15 |