Osteoarthritis, KneeNCT05673720
Brain Stimulation and Meditation for Pain After Total Knee Arthroplasty
A study testing active tDCS paired with active MBM in people with Osteoarthritis, Knee, run by Florida State University at 1 site in United States.
Trial summary
Feasibility, acceptability, and preliminary efficacy of combined transcranial direct current stimulation and mindfulness for pain after total knee arthroplasty Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Osteoarthritis, 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
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2023to 25 Oct 2024
- 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
- elective unilateral knee total replacement
- mentally capable of reading, giving consent and following instructions
- being able to answer questions in English
- not pregnant
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
- current use of sodium channel blockers, calcium channel blockers and NMDS receptor antagonists
- hospitalization within the preceding year for psychiatric illness
- no access to a device with internet access that can be used for secure videoconferencing for real-time remote supervision
Trial locations and contacts
1 site in 1 country.
United States1 site
Tallahassee Orthopedic Clinic
Tallahassee, Florida, 32308
About this study
Official title: Feasibility, Acceptability, and Preliminary Efficacy of Combined Transcranial Direct Current Stimulation and Mindfulness for Pain After Total Knee Arthroplasty
Feasibility, acceptability, and preliminary efficacy of combined transcranial direct current stimulation and mindfulness for pain after total knee arthroplasty
Read the detailed description
The project is to assess the preliminary feasibility, acceptability, and efficacy of self-administered preoperative tDCS+MBI in older adults (50+) undergoing TKR. And to determine the effects of 5, 20-minute preoperative self-administered tDCS sessions combined with brief MBI on analgesic medication consumption following TKR.
- Conditions
- Osteoarthritis, Knee
- Being tested
- active tDCS paired with active MBM, sham tDCS paired with sham MBM
- Medical subject headings
- Osteoarthritis, Knee
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 for 5 times 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 for 5 times by a recorded meditation.
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. 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 |
|---|---|---|
| preoperative active tDCS+MBI | Experimental | Active tDCS with simultaneous meditation intervention will be applied. Receives: Device: active tDCS paired with active MBM |
| preoperative sham tDCS+MBI | Sham comparator | Sham tDCS with simultaneous sham MBM intervention will be delivered. 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.
Analgesic Consumption
The dose of every opioid received within 3 days postoperatively will be transcribed and converted into standardized parenteral morphine equivalents using the Centers for Disease and Control Prevention Guidelines on opioids. A total in milligrams will be calculated for each day and means will be obtained for all groups.
Measured: day 3 after surgery
Secondary outcomes (4)
Numerical Rating Scale (NRS)
The NRS total score ranges from 0 (no pain) to 10 (most intense pain imaginable).
Measured: day 3 after surgery
Brief Pain Inventory (BPI)
It includes seven items and evaluates the impact of pain on general activity, mood, walking, work, relationships, sleep, and enjoyment of life via a NRS (0-10). Each item represents a subscale and can be scored and analyzed individually (0-10), with the anchors being "does not interfere" (0) and "completely interferes" (10). A total interference score can also be calculated by taking the sum of all the items (score range 0-70). A higher score reflects worse outcomes : higher pain interference with activities.
Measured: day 3 after surgery
Patient Health Questionnaire-4 (PHQ-4)
The PHQ-4 has a total score range of 0-12, which is broken down into four ranges: normal (0-2), mild (3-5), moderate (6-8), and severe (9-12) psychological distress. For the subscales (PHQ-2 for depression and GAD-2 for anxiety), the score range is 0-6. higher values represent a worse outcome
Measured: day 3 after surgery
Pain Catastrophizing Scale (PCS)
to assess patients' pain-related catastrophic thoughts. It includes 13 items divided into three subscales: rumination (4 items), magnification (3 items), and helplessness (6 items). Each item is rated on a 5-point scale with the end points not at all (score=0) and all the time (score=4). The total score range for the Pain Catastrophizing Scale (PCS) is 0 to 52, where a higher score indicates greater levels of pain catastrophizing.
Measured: day 3 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start15 May 2023
- Primary completion25 Sep 2024
- Study completion25 Oct 2024
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, KneeStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geraldine Martorella, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673720
- Sponsor's protocol ID
- 00003476
- Other IDs
- 140009-140
- Status last verified
- Nov 2025
- First submitted
- 19 Dec 2022
- Last updated
- 24 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Preliminary Efficacy of Combined Transcranial Direct Current Stimulation and Mindfulness for Pain After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05673720
- Acronym / sponsor ID
- 00003476
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 6 Jan 2023 (actual)
- Results
- Posted 24 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Feasibility, acceptability, and preliminary efficacy of combined transcranial direct current stimulation and mindfulness for pain after total knee arthroplasty
Detailed description
The project is to assess the preliminary feasibility, acceptability, and efficacy of self-administered preoperative tDCS+MBI in older adults (50+) undergoing TKR. And to determine the effects of 5, 20-minute preoperative self-administered tDCS sessions combined with brief MBI on analgesic medication consumption following TKR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preoperative active tDCS+MBI | Experimental | Device: active tDCS paired with active MBMActive tDCS with simultaneous meditation intervention will be applied. |
| preoperative sham tDCS+MBI | Sham comparator | Device: sham tDCS paired with sham MBMSham tDCS with simultaneous sham MBM intervention will be delivered. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- elective unilateral knee total replacement
- mentally capable of reading, giving consent and following instructions
- being able to answer questions in English
- not pregnant
Key exclusion criteria (6 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
- current use of sodium channel blockers, calcium channel blockers and NMDS receptor antagonists
- hospitalization within the preceding year for psychiatric illness
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 for 5 times 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 for 5 times by a recorded meditation. | Device | preoperative active tDCS+MBI |
| 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. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM. | Device | preoperative sham tDCS+MBI |
Primary outcome
Analgesic Consumption
Time frame: day 3 after surgery
The dose of every opioid received within 3 days postoperatively will be transcribed and converted into standardized parenteral morphine equivalents using the Centers for Disease and Control Prevention Guidelines on opioids. A total in milligrams will be calculated for each day and means will be obtained for all groups.
4 secondary outcomes
Numerical Rating Scale (NRS)
Time frame: day 3 after surgery
Brief Pain Inventory (BPI)
Time frame: day 3 after surgery
Patient Health Questionnaire-4 (PHQ-4)
Time frame: day 3 after surgery
Pain Catastrophizing Scale (PCS)
Time frame: day 3 after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Osteoarthritis, Knee, run by Florida State University 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 6 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 24 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 24 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?
Analgesic Consumption (time frame: day 3 after surgery). 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 24 Nov 2025.