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Mind-body Therapy (Remotely Delivered) for Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mind-body exercise and education
Sponsored by
Tufts Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tufts Medical Center, Division of Rheumatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Tai Chi

Wellness Education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Brain Morphometry
Brain morphometry as measured by gray matter volume difference between baseline and 12 weeks

Full Information

First Posted
December 9, 2020
Last Updated
March 13, 2023
Sponsor
Tufts Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04678999
Brief Title
Mind-body Therapy (Remotely Delivered) for Knee Osteoarthritis
Official Title
Neurobiological Mechanisms of Mind-body Therapy (Remotely Delivered) for Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tai Chi
Arm Type
Experimental
Arm Description
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.
Arm Title
Wellness Education
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mind-body exercise and education
Intervention Description
The intervention will delivered via a secure Zoom video platform.
Primary Outcome Measure Information:
Title
resting state functional connectivity
Description
Change in resting state functional connectivity between baseline to 12 weeks as measured by fMRI.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Brain Morphometry
Description
Brain morphometry as measured by gray matter volume difference between baseline and 12 weeks
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chenchen Wang
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center, Division of Rheumatology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Mind-body Therapy (Remotely Delivered) for Knee Osteoarthritis

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