Mind-body Therapy (Remotely Delivered) for Knee Osteoarthritis

Sponsor
Tufts Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04678999
Collaborator
(none)
50
1
2
26.9
1.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mind-body exercise and education
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Neurobiological Mechanisms of Mind-body Therapy (Remotely Delivered) for Knee Osteoarthritis
Actual Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Nov 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tai Chi

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.

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

Experimental: Wellness Education

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.

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

Outcome Measures

Primary Outcome Measures

  1. resting state functional connectivity [12 weeks]

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

Secondary Outcome Measures

  1. Brain Morphometry [12 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tufts Medical Center, Division of Rheumatology Boston Massachusetts United States 02111

Sponsors and Collaborators

  • Tufts Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT04678999
Other Study ID Numbers:
  • 13281
First Posted:
Dec 22, 2020
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2022