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Completed

NCT Number: NCT04678999

Mind-body Therapy (Remotely Delivered) for Knee Osteoarthritis

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center, Division of Rheumatology

Boston, Massachusetts, 02111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mind-body exercise and education

Behavioral

The intervention will delivered via a secure Zoom video platform.

Primary outcomes

  1. resting state functional connectivity

    Time frame: 12 weeks

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

Secondary outcomes

  1. Brain Morphometry

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Registry information

Official study title

Neurobiological Mechanisms of Mind-body Therapy (Remotely Delivered) for Knee Osteoarthritis

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 22, 2020
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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