Mind-body Therapy (Remotely Delivered) for Knee Osteoarthritis

NCT ID: NCT04678999

Last Updated: 2023-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-11-30

Brief Summary

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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.

Detailed Description

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The study will investigate the central mechanism of knee OA pain using brain imaging technology to evaluate how brain function and structure change in response to mind-body exercise over time. Tai Chi mind body therapy may work by modulating the interaction among cognitive control network, default mode network, descending pain modulation system, limbic system, salient network, and sensory motor system through complex mind-body interactions. By combining multiple brain imaging modalities measurements, investigators will examine the neural substrates of Tai Chi compared with wellness education in adults with knee OA. The investigators will compare changes in resting state functional connectivity of the cognitive control network, brain morphometry and functional magnetic resonance imaging responses to pressure pain, as well as their association with clinical outcomes. Results of this innovative mechanistic study will have important therapeutic implications and provide critical insight into the clinical, behavioral, and neurobiological mechanisms of the potential disease-modifying role of mind-body therapies for knee OA.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Tai Chi

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.

Group Type EXPERIMENTAL

Mind-body exercise and education

Intervention Type BEHAVIORAL

The intervention will delivered via a secure Zoom video platform.

Wellness Education

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.

Group Type EXPERIMENTAL

Mind-body exercise and education

Intervention Type BEHAVIORAL

The intervention will delivered via a secure Zoom video platform.

Interventions

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Mind-body exercise and education

The intervention will delivered via a secure Zoom video platform.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tufts Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chenchen Wang

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

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Tufts Medical Center, Division of Rheumatology

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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13281

Identifier Type: -

Identifier Source: org_study_id

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