Osteo Arthritis Knee
Conditions
Keywords
meditation
Brief summary
This clinical trial aims to evaluate whether a 2 week regimen of transcranial direct current stimulation (tDCS) paired with mindfulness-based meditation (MBM) can improve pain modulation, reduce clinical pain, and alleviate osteoarthritis (OA)-related symptoms in patients with knee OA.
Interventions
Active tDCS with a constant current intensity of 2 milli ampere (mA) will be applied for 20 minutes per session daily for 2 weeks via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session daily for 2 weeks by a recorded meditation.
DEVICEsham tDCS paired with active MBM
For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds during each 20-minute session, conducted daily for 2 weeks. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session daily for 2 weeks by a recorded meditation.
DEVICEactive tDCS paired with sham MBM
Active tDCS with a constant current intensity of 2 milli ampere (mA) will be applied for 20 minutes per session daily for 2 weeks via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM.
For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds during each 20-minute session, conducted daily for 2 weeks. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM.
Sponsors
National Institute of Nursing Research (NINR)
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* have symptomatic knee OA based on American College of Rheumatology clinical criteria * have had knee OA pain in the past 3 months with an average of at least 30 on a 0-100 NRS for pain, * can speak and read English * have no plan to change medication regimens for pain throughout the trial
Exclusion criteria
* history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation * systemic rheumatic disorders, including rheumatoid arthritis,systemic lupus erythematosus, and fibromyalgia * alcohol/substance abuse * diminished cognitive function that would interfere with understanding study procedures (i.e., Mini-Mental Status Exam score ≤ 23) * pregnancy or lactation * prosthetic knee replacement or non-arthroscopic surgery to the affected knee * hospitalization within the preceding year for psychiatric illness * no access to a device that can be used for secure videoconferencing for real-time remote supervision.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Numeric Rating Score (NRS) of Pain | baseline, week 2 (after 10 tDCS sessions) | The Numeric Rating Scale (NRS) is a subjective measure of pain intensity. The NRS total score ranges from 0 (no pain) to 100 (most intense pain imaginable). Change in NRS = Week 2 (post-intervention) NRS - Baseline (pre-intervention) NRS. A decrease in NRS score indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). | baseline, week 2 (after 10 tDCS sessions) | 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 = Week 2 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
A total of 208 participants consented to participate in the study. However, 8 participants withdrew due to being unable to attend the remaining sessions and assessments.
Participants by arm
| Arm | Count |
|---|---|
| Active tDCS Paired With Active MBM, A transcranial direct current stimulation (tDCS) of 2mA is applied for 20 minutes, where a constant current of 2mA is delivered to the scalp through electrodes to modulate neural activity. Alongside this, mindfulness-based meditation is conducted for 20 minutes, focusing on cultivating awareness and concentration through practices such as breath observation and mindful awareness of thoughts and sensations. Both interventions are applied simultaneously, aiming to investigate their combined effects on brain function and mental state. | 53 |
| Sham tDCS Paired With Active MBM A 2mA transcranial direct current stimulation (tDCS) is applied for 30 seconds. Simultaneously, mindfulness-based meditation is conducted for 20 minutes, involving practices aimed at enhancing awareness and focus, such as observing the breath and maintaining attention to present-moment experiences. | 53 |
| Active tDCS Paired With Sham MBM A 2mA transcranial direct current stimulation (tDCS) is applied for 20 minutes, with a constant current of 2mA delivered through electrodes placed on the scalp to modulate neural activity in targeted brain regions. Simultaneously, mindfulness-based meditation without specific instructions is conducted for 20 minutes. In this meditation practice, participants are encouraged to focus on their breath and cultivate general awareness of their thoughts and sensations, without any particular guidance on how to direct their attention. | 50 |
| Sham tDCS Paired With Sham MBM A 2mA transcranial direct current stimulation (tDCS) is applied for 30 seconds. Simultaneously, mindfulness-based meditation without specific instructions is conducted for 20 minutes. In this practice, participants are encouraged to cultivate awareness and attention to their thoughts, feelings, and bodily sensations without any particular guidance or structured focus, allowing for an open-ended, self-directed meditation experience. | 52 |
| Total | 208 |
Baseline characteristics
| Characteristic | Active tDCS Paired With Sham MBM | Active tDCS Paired With Active MBM, | Sham tDCS Paired With Active MBM | Sham tDCS Paired With Sham MBM | Total |
|---|---|---|---|---|---|
| Age, Continuous | 68.06 years STANDARD_DEVIATION 7.42 | 66.49 years STANDARD_DEVIATION 7.74 | 67.19 years STANDARD_DEVIATION 7.89 | 68.88 years STANDARD_DEVIATION 6.92 | 67.6 years STANDARD_DEVIATION 7.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 2 Participants | 3 Participants | 2 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants | 51 Participants | 50 Participants | 50 Participants | 197 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 | 5 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 7 Participants | 4 Participants | 6 Participants | 20 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 | 4 Participants | 2 Participants | 3 Participants | 2 Participants | 11 Participants |
| Race (NIH/OMB) White | 43 Participants | 44 Participants | 41 Participants | 43 Participants | 171 Participants |
| Sex: Female, Male Female | 34 Participants | 34 Participants | 40 Participants | 34 Participants | 142 Participants |
| Sex: Female, Male Male | 16 Participants | 19 Participants | 13 Participants | 18 Participants | 66 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 / 53 | 0 / 53 | 0 / 50 | 0 / 52 |
| other Total, other adverse events | 0 / 53 | 0 / 53 | 0 / 50 | 0 / 52 |
| serious Total, serious adverse events | 0 / 53 | 0 / 53 | 0 / 50 | 0 / 52 |
Outcome results
Primary
Change in Numeric Rating Score (NRS) of Pain
The Numeric Rating Scale (NRS) is a subjective measure of pain intensity. The NRS total score ranges from 0 (no pain) to 100 (most intense pain imaginable). Change in NRS = Week 2 (post-intervention) NRS - Baseline (pre-intervention) NRS. A decrease in NRS score indicates improvement.
Time frame: baseline, week 2 (after 10 tDCS sessions)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| active tDCS paired with active MBM | Change in Numeric Rating Score (NRS) of Pain | -19.41 units on a scale | Standard Deviation 19.76 |
| sham tDCS paired with active MBM | Change in Numeric Rating Score (NRS) of Pain | -7.16 units on a scale | Standard Deviation 22.24 |
| active tDCS paired with sham MBM | Change in Numeric Rating Score (NRS) of Pain | -16.78 units on a scale | Standard Deviation 17.9 |
| sham tDCS paired with sham MBM | Change in Numeric Rating Score (NRS) of Pain | -6.20 units on a scale | Standard Deviation 17.99 |
Secondary
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 = Week 2 total WOMAC score - Baseline (pre-intervention) total WOMAC score. The lower change scores represents improvement in pain, movement, and stiffness.
Time frame: baseline, week 2 (after 10 tDCS sessions)
Population: Comparison of WOMAC score changes between four groups at 2 weeks from baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| active tDCS paired with active MBM | Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). | -6.98 units on a scale | Standard Deviation 13.27 |
| sham tDCS paired with active MBM | Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). | -7.90 units on a scale | Standard Deviation 14.2 |
| active tDCS paired with sham MBM | Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). | -8.08 units on a scale | Standard Deviation 13.39 |
| sham tDCS paired with sham MBM | Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). | -4.50 units on a scale | Standard Deviation 11.33 |