Mind-body Therapy (Remotely Delivered) for Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04678999
• Other study ID #: 13281
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: March 2023
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Mind-body exercise and education
The intervention will delivered via a secure Zoom video platform.

Locations

Country	Name	City	State
United States	Tufts Medical Center, Division of Rheumatology	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	resting state functional connectivity	Change in resting state functional connectivity between baseline to 12 weeks as measured by fMRI.	12 weeks
Secondary	Brain Morphometry	Brain morphometry as measured by gray matter volume difference between baseline and 12 weeks	12 weeks