Knee OsteoarthritisTAICHIKNEENCT06384898
Remote Tai Chi for Knee Osteoarthritis
A study testing Remote Tai Chi in people with Knee Osteoarthritis, run by Tufts Medical Center at 1 site in United States.
Trial summary
The goal of this pragmatic randomized trial is to evaluate the effectiveness of remote Tai Chi to treat knee pain in adults with knee osteoarthritis. The main questions the trial aims to answer are: Compared to routine care, will patients with Knee OA receiving remote Tai Chi exhibit greater improvement in… Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Remote Tai Chi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2025to 10 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 50 years or older with clinician diagnosis of knee osteoarthritis
- Active patient within a participating healthcare system
- A score of 40 (visual analog version) or greater on at least 1 item of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (range of 0 to 100, with higher scores indicating greater pain).
- Ability to provide informed consent
- Access to a telehealth-capable device, such as a computer, tablet, or smartphone
- Ability to complete study procedures remotely in English
- If randomized to the Tai Chi group, willing to comply with the Tai Chi program (twice-a-week remote sessions for 12 weeks)
- If randomized to the Routine Care group, willing to abstain from Tai Chi programs until completion of the study
Who cannot join
- Current participation in Tai Chi practice
- Serious medical conditions (e.g., dementia, significant neurological deficits or neurodegenerative disorder, active cancer treatment, psychosis, sensory deficits) limiting the participant's ability to participate in the Tai Chi safely, as determined by the principal investigators
- Prior total knee replacement or planned total knee replacement during the study period
- Inability to ambulate independently or rise from a chair without assistance
- Reports severe depression defined by a Beck Depression Inventory (BDI-II) score of 29 or more.
- Reports suicidal ideations defined by a score on BDI-II item of 2 or 3 ('I would like to kill myself' or 'I would kill myself if I had the chance').
- Concurrent participation in another interventional trial within 30 days before enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Sherwood Alexis, MHA, MBA, 617-636-2612, sherwood.alexis@tuftsmedicalcenter.org
Chenchen Wang, MD
About this study
Official title: Remote Tai Chi for Knee Osteoarthritis: An Embedded Pragmatic Trial
The goal of this pragmatic randomized trial is to evaluate the effectiveness of remote Tai Chi to treat knee pain in adults with knee osteoarthritis. The main questions the trial aims to answer are:
- Compared to routine care, will patients with Knee OA receiving remote Tai Chi exhibit greater improvement in knee-related pain (WOMAC pain score, primary outcome), pain interference (PROMIS-Pain Interference, secondary outcome), and health-related quality of life at 3 months?
- Does remote tai chi decreases healthcare utilization and analgesic use over the one-year study period?
Researchers will compare remote Tai Chi added to routine care to routine care alone to see if remote tai chi works to treat knee osteoarthritis pain. Participants will participate in remotely delivered web-based tai chi sessions, twice a week for 12 weeks, or will continue to receive routine care. Participants will be followed for 12 months after randomization.
Read the detailed description
Investigators will conduct a 12-month embedded, pragmatic, hybrid type 1 effectiveness-implementation, individually randomized group-treatment trial that will compare the effects of a 3-month twice weekly remotely delivered web-based Tai Chi intervention plus routine care versus routine care alone across five health care systems (Tufts Medical Center, Boston Medical Center, University of California Los Angeles Health, Cleveland Clinic and University of New Mexico) in five geographic regions (Eastern Massachusetts, Southern California, Northeast Ohio (Cleveland Clinic), Southern Florida (Cleveland Clinic), and Central New Mexico). Investigators will enroll a total of 480 diverse patients with a clinical diagnosis of Knee OA. Participants will be evaluated at baseline and 3 months, with additional follow-up at 6 and 12 months.
- Conditions
- Knee Osteoarthritis
- Being tested
- Remote Tai Chi
- Keywords
- Pragmatic Clinical Trial, Implementation Science, Mind-body Therapies, Tai Chi, Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Tai ChiOther
Tai Chi mind-body exercise is a complex, multi-component nonpharmacological intervention integrating physical, psychological, emotional, and behavioral elements.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi + Routine Care | Experimental | The intervention will be delivered via a HIPAA-secure web-based video platform. All remote Tai Chi sessions will be 60 minutes, twice a week, for 3 months. All program components will use the Yang style Tai Chi, and every session will include warm up, review of principles, meditation with movement, breathing techniques and relaxation. Receives: Other: Remote Tai Chi |
| Routine Care | No intervention | Participants will be encouraged to continue their ongoing care for Knee OA by their providers. In addition, primary care providers and other participating clinicians in the health system will receive information from the study team on routine care or "2019 ACR Guideline-Based Care." At the end of the 12-month trial period, routine care participants will be offered access to recordings for the full 3-month Tai Chi program (24 sessions). |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC Pain Score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score rated on a Visual Analog Scale (VAS) of 0-100 mm.
Measured: 3 months from randomization
Secondary outcomes (3)
PROMIS Pain Interference score
The PROMIS Pain Interference short form 6b evaluates the extent to which pain interferes with physical, emotional and social activities. The raw score ranges between 6-30 and the T score ranges between 41.0-78.3, with higher scores indicating that pain has a greater negative impact.
Measured: 3 months from randomization
SF-12 PCS score
The 12-item Short Form Health Survey (SF-12) has two summary scales, the Mental Health Component Score (MCS) and the Physical Component Score (PCS). Both scores range from 0 to 100, with higher scores indicating better mental and physical health.
Measured: 3 months from randomization
Number of knee joint injections
Total number of intra-articular injections identified through EHR and patient questionnaires.
Measured: 12 months from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start21 Jan 2025
- Primary completion5 Mar 2027 (estimated)
- Study completion10 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Model description
- The study is an individually randomized group-treatment (IRGT) trial. Individuals randomly allocated to remote Tai Chi receive the intervention with other participants through an instructor.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Medical Center, University of California, Los Angeles, The Cleveland Clinic, University of New Mexico, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Chenchen Wang, MD, MSc, Principal investigator, Tufts Medical CenterRobert Saper, MD, MPH, Principal investigator, The Cleveland ClinicEric Roseen, DC, PhD, Principal investigator, Boston Medical CenterHelen Lavetrsky, MD, MS, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384898
- Sponsor's protocol ID
- STUDY00002259
- Other IDs
- UH3AT012413
- Acronym
- TAICHIKNEE
- Status last verified
- Oct 2026
- First submitted
- 26 Mar 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will submit and share de-identified individual patient data as described in our Data Management and Sharing Plan and will follow NIH policies for data sharing
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Tai Chi for Knee Osteoarthritis: An Embedded Pragmatic Trial
- ClinicalTrials.gov ID
- NCT06384898
- Acronym / sponsor ID
- TAICHIKNEE / STUDY00002259
- Conditions
- Knee Osteoarthritis
- Keywords
- Pragmatic Clinical Trial, Implementation Science, Mind-body Therapies, Tai Chi, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Boston Medical Center, University of California, Los Angeles, The Cleveland Clinic, University of New Mexico, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 5 Mar 2027 (estimated)
- Study completion
- 10 Dec 2027 (estimated)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pragmatic randomized trial is to evaluate the effectiveness of remote Tai Chi to treat knee pain in adults with knee osteoarthritis. The main questions the trial aims to answer are:
- Compared to routine care, will patients with Knee OA receiving remote Tai Chi exhibit greater improvement in knee-related pain (WOMAC pain score, primary outcome), pain interference (PROMIS-Pain Interference, secondary outcome), and health-related quality of life at 3 months?
- Does remote tai chi decreases healthcare utilization and analgesic use over the one-year study period?
Researchers will compare remote Tai Chi added to routine care to routine care alone to see if remote tai chi works to treat knee osteoarthritis pain. Participants will participate in remotely delivered web-based tai chi sessions, twice a week for 12 weeks, or will continue to receive routine care. Participants will be followed for 12 months after randomization.
Detailed description
Investigators will conduct a 12-month embedded, pragmatic, hybrid type 1 effectiveness-implementation, individually randomized group-treatment trial that will compare the effects of a 3-month twice weekly remotely delivered web-based Tai Chi intervention plus routine care versus routine care alone across five health care systems (Tufts Medical Center, Boston Medical Center, University of California Los Angeles Health, Cleveland Clinic and University of New Mexico) in five geographic regions (Eastern Massachusetts, Southern California, Northeast Ohio (Cleveland Clinic), Southern Florida (Cleveland Clinic), and Central New Mexico). Investigators will enroll a total of 480 diverse patients with a clinical diagnosis of Knee OA. Participants will be evaluated at baseline and 3 months, with additional follow-up at 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The study is an individually randomized group-treatment (IRGT) trial. Individuals randomly allocated to remote Tai Chi receive the intervention with other participants through an instructor.
| Arm | Type | Receives |
|---|---|---|
| Tai Chi + Routine Care | Experimental | Other: Remote Tai ChiThe intervention will be delivered via a HIPAA-secure web-based video platform. All remote Tai Chi sessions will be 60 minutes, twice a week, for 3 months. All program components will use the Yang style Tai Chi, and every session will include warm up, review of principles, meditation with movement, breathing techniques and relaxation. |
| Routine Care | No intervention | –Participants will be encouraged to continue their ongoing care for Knee OA by their providers. In addition, primary care providers and other participating clinicians in the health system will receive information from the study team on routine care or "2019 ACR Guideline-Based Care." At the end of the 12-month trial period, routine care participants will be offered access to recordings for the full 3-month Tai Chi program (24 sessions). |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 50 years or older with clinician diagnosis of knee osteoarthritis
- Active patient within a participating healthcare system
- A score of 40 (visual analog version) or greater on at least 1 item of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (range of 0 to 100, with higher scores indicating greater pain).
- Ability to provide informed consent
- Access to a telehealth-capable device, such as a computer, tablet, or smartphone
Key exclusion criteria (7 listed)
- Current participation in Tai Chi practice
- Serious medical conditions (e.g., dementia, significant neurological deficits or neurodegenerative disorder, active cancer treatment, psychosis, sensory deficits) limiting the participant's ability to participate in the Tai Chi safely, as determined by the principal investigators
- Prior total knee replacement or planned total knee replacement during the study period
- Inability to ambulate independently or rise from a chair without assistance
- Reports severe depression defined by a Beck Depression Inventory (BDI-II) score of 29 or more.
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 |
|---|---|---|
| Remote Tai ChiTai Chi mind-body exercise is a complex, multi-component nonpharmacological intervention integrating physical, psychological, emotional, and behavioral elements. | Other | Tai Chi + Routine Care |
Primary outcome
WOMAC Pain Score
Time frame: 3 months from randomization
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score rated on a Visual Analog Scale (VAS) of 0-100 mm.
3 secondary outcomes
PROMIS Pain Interference score
Time frame: 3 months from randomization
SF-12 PCS score
Time frame: 3 months from randomization
Number of knee joint injections
Time frame: 12 months from randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. This study will submit and share de-identified individual patient data as described in our Data Management and Sharing Plan and will follow NIH policies for data sharing
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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.
Chenchen Wang, MD, MSc principal investigator
Tufts Medical Center
Robert Saper, MD, MPH principal investigator
The Cleveland Clinic
Eric Roseen, DC, PhD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Tai Chi in people with Knee Osteoarthritis, run by Tufts Medical Center 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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 8 Oct 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chenchen Wang, MD, MSc (617-636-3251, Chenchen.Wang@tuftsmedicine.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC Pain Score (time frame: 3 months from randomization). 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 8 Oct 2026.