NCT06384898

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
27mo left

Started Apr 2025

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Apr 2025Aug 2028

First Submitted

Initial submission to the registry

March 26, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 25, 2024

Completed
12 months until next milestone

Study Start

First participant enrolled

April 7, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

2.7 years

First QC Date

March 26, 2024

Last Update Submit

July 2, 2025

Conditions

Knee Osteoarthritis

Keywords

Pragmatic Clinical TrialImplementation ScienceMind-body TherapiesTai ChiKnee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • WOMAC Pain Score

    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score rated on a Visual Analog Scale (VAS) of 0-100 mm.

    3 months from randomization

Secondary Outcomes (3)

  • PROMIS Pain Interference score

    3 months from randomization

  • SF-12 PCS score

    3 months from randomization

  • Number of knee joint injections

    12 months from randomization

Other Outcomes (37)

  • WOMAC Pain Score

    6 months from randomization

  • WOMAC Pain Score

    12 months from randomization

  • PROMIS Pain Interference score

    6 months from randomization

  • +34 more other outcomes

Study Arms (2)

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.

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).

Interventions

Remote Tai ChiOTHER

Tai Chi mind-body exercise is a complex, multi-component nonpharmacological intervention integrating physical, psychological, emotional, and behavioral elements.

Tai Chi + Routine Care

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 50 years or older
  • Treating clinician diagnosis of knee osteoarthritis
  • Have a score of 40 (visual analog version) or greater on at least 1 of the 5 questions in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (range of 0 to 100, with higher scores indicating greater pain) at baseline.
  • Able to provide informed consent
  • If randomized to the Routine Care group, willing to abstain from Tai Chi programs until completion of the study
  • If randomized to the Tai Chi group, willing to comply with the Tai Chi program (twice-a-week remote sessions for 12 weeks)
  • Has access to a home computer or device that will allow telehealth (bidirectional audio and video) delivery of the intervention
  • Is an active patient at one of the 4 participating healthcare system

You may not qualify if:

  • Currently practicing Tai Chi
  • 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
  • Unable to walk without a cane or other assistive device
  • Any previous or scheduled knee replacement
  • 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').
  • Not English speaking
  • Enrollment in any other clinical trial within the last 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Chenchen Wang, MD, MSc

    Tufts Medical Center

    PRINCIPAL INVESTIGATOR

  • Robert Saper, MD, MPH

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

  • Eric Roseen, DC, PhD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

  • Helen Lavetrsky, MD, MS

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chenchen Wang, MD, MSc

CONTACT

617-636-3251Chenchen.Wang@tuftsmedicine.org

Sherwood Alexis, MHA, MBA

CONTACT

617-636-5405sherwood.alexis@tuftsmedicalcenter.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2024

First Posted

April 25, 2024

Study Start

April 7, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

August 31, 2028

Last Updated

July 8, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The time of results publication or the end of the funding period.

Locations

US(1)