Clinical trial NCT04678999: Mind-body Therapy (Remotely Delivered) for Knee Osteoarthritis
Official title: Neurobiological Mechanisms of Mind-body Therapy (Remotely Delivered) for Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: resting state functional connectivity
timeFrame: 12 weeks
Secondary outcomes:
measure: Brain Morphometry
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center, Division of Rheumatology
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Chenchen Wang
role: PRINCIPAL_INVESTIGATOR
References: