Osteo Arthritis KneeNCT04375072
Home-based tDCS and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms
A study testing active tDCS paired with active MBM in people with Osteo Arthritis Knee, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- active tDCS paired with active MBM
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2020to 30 Jan 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combination Therapy of Home-based Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms in Older Adults With Knee Osteoarthritis
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.
- Conditions
- Osteo Arthritis Knee
- Being tested
- active tDCS paired with active MBM, sham tDCS paired with active MBM, active tDCS paired with sham MBM, sham tDCS paired with sham MBM
- Keywords
- meditation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active tDCS paired with active MBMDevice
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.
sham tDCS paired with active MBMDevice
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.
active tDCS paired with sham MBMDevice
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.
sham tDCS paired with sham MBMDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| active tDCS paired with active MBM, | Experimental | Not described Receives: Device: active tDCS paired with active MBM |
| sham tDCS paired with active MBM | Active comparator | Not described Receives: Device: sham tDCS paired with active MBM |
| active tDCS paired with sham MBM | Active comparator | Not described Receives: Device: active tDCS paired with sham MBM |
| sham tDCS paired with sham MBM | Sham comparator | Not described Receives: Device: sham tDCS paired with sham MBM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, week 2 (after 10 tDCS sessions)
Secondary outcomes (1)
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.
Measured: baseline, week 2 (after 10 tDCS sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start13 Aug 2020
- Primary completion30 Jan 2025
- Study completion30 Jan 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Hyochol Ahn, University of Arizona
- Investigators
- Hyochol Ahn, PhD,RN,MSN, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375072
- Sponsor's protocol ID
- STUDY00003164
- Other IDs
- R01NR019051, R01NR019051-03S1
- Status last verified
- Oct 2025
- First submitted
- 30 Apr 2020
- Last updated
- 12 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lee C, Kim Y, Kim S, Park J, Sun X, Chen CX, Kwoh CK, Liu S, Ahn D, Kim H, Ahn H. Experimental Pain Phenotypes in Individuals With Symptomatic Knee Osteoarthritis: A Neural Network-Based Clustering Approach. Pain Res Manag. 2026;2026(1):e5069475. doi: 10.1155/prm/5069475.
PubMed 42605842Park J, Lee C, Lin L, Fain MJ, Telkes I, Dahmer S, Park L, Hoang J, Miao H, Ahn H. A randomized trial of a digitally delivered, home-based neuromodulation and mindfulness intervention for pain management in older adults with knee osteoarthritis. NPJ Digit Med. 2026 Mar 31;9(1):397. doi: 10.1038/s41746-026-02577-7.
PubMed 41917434
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy of Home-based Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms in Older Adults With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04375072
- Acronym / sponsor ID
- STUDY00003164
- Conditions
- Osteo Arthritis Knee
- Keywords
- meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 5 May 2020 (actual)
- Results
- Posted 12 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| active tDCS paired with active MBM, | Experimental | Device: active tDCS paired with active MBM |
| sham tDCS paired with active MBM | Active comparator | Device: sham tDCS paired with active MBM |
| active tDCS paired with sham MBM | Active comparator | Device: active tDCS paired with sham MBM |
| sham tDCS paired with sham MBM | Sham comparator | Device: sham tDCS paired with sham MBM |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| active tDCS paired with active MBMActive 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. | Device | active tDCS paired with active MBM, |
| sham tDCS paired with active MBMFor 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. | Device | sham tDCS paired with active MBM |
| active tDCS paired with sham MBMActive 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. | Device | active tDCS paired with sham MBM |
| sham tDCS paired with sham MBMFor 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. | Device | sham tDCS paired with sham MBM |
Primary outcome
Change in Numeric Rating Score (NRS) of Pain
Time frame: 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.
1 secondary outcome
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Time frame: baseline, week 2 (after 10 tDCS sessions)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42605842Lee C, Kim Y, Kim S, Park J, Sun X, Chen CX, Kwoh CK, Liu S, Ahn D, Kim H, Ahn H. Experimental Pain Phenotypes in Individuals With Symptomatic Knee Osteoarthritis: A Neural Network-Based Clustering Approach. Pain Res Manag. 2026;2026(1):e5069475. doi: 10.1155/prm/5069475.
- Derived from this study: PubMed 41917434Park J, Lee C, Lin L, Fain MJ, Telkes I, Dahmer S, Park L, Hoang J, Miao H, Ahn H. A randomized trial of a digitally delivered, home-based neuromodulation and mindfulness intervention for pain management in older adults with knee osteoarthritis. NPJ Digit Med. 2026 Mar 31;9(1):397. doi: 10.1038/s41746-026-02577-7.
- 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.
Hyochol Ahn, PhD,RN,MSN principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active tDCS paired with active MBM in people with Osteo Arthritis Knee, run by University of Arizona at 1 site 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 4 inclusion and 8 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 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 12 Nov 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 Numeric Rating Score (NRS) of Pain (time frame: baseline, week 2 (after 10 tDCS sessions)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04375072, which also lists 2 linked publications.
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 12 Nov 2025.