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Mind-body Therapy (Remotely Delivered) for Knee Osteoarthritis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04678999
Enrollment
50
Registered
2020-12-22
Start date
2020-09-01
Completion date
2022-11-30
Last updated
2023-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

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.

Interventions

BEHAVIORALMind-body exercise and education

The intervention will delivered via a secure Zoom video platform.

Sponsors

Tufts Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
resting state functional connectivity12 weeksChange in resting state functional connectivity between baseline to 12 weeks as measured by fMRI.

Secondary

MeasureTime frameDescription
Brain Morphometry12 weeksBrain morphometry as measured by gray matter volume difference between baseline and 12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026