NCT04678999

Brief Summary

This proposal aims to provide crucial knowledge about the neurobiological mechanisms underlying Tai Chi mind-body therapy for knee osteoarthritis (OA). The central mechanism of knee OA pain will be investigated using brain imaging technology to evaluate how brain function and structure change in response to mind-body exercise over time. Sixty eligible individuals who meet the American College of Rheumatology criteria for knee OA will be randomized into Tai Chi or wellness education interventions for 12 weeks. The investigators will compare changes in resting state functional connectivity of the cognitive control network, and functional magnetic resonance imaging responses to pressure pain and brain morphometry, as well as their association with clinical outcomes. The findings will lead to the establishment of a new treatment paradigm in OA and have broad application to the management of chronic musculoskeletal pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

2.2 years

First QC Date

December 9, 2020

Last Update Submit

March 13, 2023

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • resting state functional connectivity

    Change in resting state functional connectivity between baseline to 12 weeks as measured by fMRI.

    12 weeks

Secondary Outcomes (1)

  • Brain Morphometry

    12 weeks

Study Arms (2)

Tai Chi

EXPERIMENTAL

The intervention will delivered via a secure Zoom video platform. One of two Tai Chi instructors will teach each of the classes. Tai Chi instructors will be selected prior to study start on the basis of familiarity with our previous Tai Chi protocols and experience working with OA patients.

Behavioral: Mind-body exercise and education

Wellness Education

EXPERIMENTAL

At each session, a variety of health professionals will provide a didactic lesson on a topic relating to knee OA. An informational brochure on knee OA education is presented to all participants during the first session. Each session will last 60 minutes including a 10-minute instructor-led program of stretching or flexibility exercises via a zoom platform.

Behavioral: Mind-body exercise and education

Interventions

Mind-body exercise and educationBEHAVIORAL

The intervention will delivered via a secure Zoom video platform.

Tai ChiWellness Education

Eligibility Criteria

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

You may qualify if:

  • Age 50 years or older
  • Unilateral or bilateral Knee OA
  • Fulfills the American College of Rheumatology Criteria for symptomatic knee OA
  • Willing to undergo MRI at baseline and follow-up
  • WOMAC pain subscale score ≥2 on weight-bearing questions

You may not qualify if:

  • Serious medical conditions limiting ability of patient to participate in the study such as, symptomatic cardiovascular, symptomatic pulmonary disease requiring supplemental oxygen, uncontrolled metabolic diseases, severe renal and liver disease
  • Presence of any contraindications to fMRI scanning. Including but not limited to: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy, weight \>300 lbs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts Medical Center, Division of Rheumatology

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Educational Status

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Chenchen Wang

    Tufts Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2020

First Posted

December 22, 2020

Study Start

September 1, 2020

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

March 14, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)