Enhancing Modulation Effects of Baduanjin Through Neuromodulation for Knee OA

Enhancing Modulation Effects of Baduanjin Through Non-invasive Neuromodulation for Knee Osteoarthritis

This study will combine brain imaging and neuromodulation tools to investigate the underlying neurobiological mechanisms of exercises. The findings will enhance our understanding of the mechanisms underlying mind-body exercise and facilitate the development of new pain management approaches.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: sham tDCS; Behavioral: BDJ; Device: tDCS; Other: exercise

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jian Kong; Phone Number: 617-7267893; Email: jkong2@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Charlestown, Massachusetts, United States, 02129
      • Recruiting
      • Massachusetts General Hospital
      • Contact: meixuan Zhu; Phone Number: 617-726-5004; Email: mzhu11@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Volunteers 45-75 years of age
• Meet the Classification Criteria of the American College of Rheumatology for osteoarthritis of the right and/or left knee for at least the past 3 months;
• Physically able to participate in the BDJ and stretching control education programs
• Willing to complete the 12-week study
• Can participate in MRI scan
• Ability to read and understand English; English can be a second language provided that the patient feels he or she can understand all the questions used in the assessment measures

Exclusion Criteria:

• Has performed BDJ, Tai Chi, Yoga, other mind-body intervention, physical therapy, or routine exercise (running, cycling, etc.) regularly in the past year
• Serious medical conditions limiting ability of patient to participate in the study, such as symptomatic cardiovascular disease, symptomatic pulmonary disease requiring supplemental oxygen, uncontrolled metabolic diseases, severe renal and liver disease
• Has had intra-articular steroid injections or reconstructive surgery in the prior 3 months on the affected knee; any intra-articular hyaluronic acid injections in the previous 6 months
• Patient Mini-Mental Status Examination score below 24 [293]
• Unable to walk without a cane or other assistive device
• The intent to undergo surgery during the time of involvement in the study
• Plan to permanently relocate from the region during the trial period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BDJ + real tDCS	Behavioral: BDJ; BDJ is a mind-body intervention; Device: tDCS; tDCS is a brain stimulation method.
Active Comparator: Exercise + real tDCS	Device: tDCS; tDCS is a brain stimulation method.; Other: exercise; exercise including stretching and other activities.
Active Comparator: BDJ + sham tDCS	Device: sham tDCS; sham tDCS; Behavioral: BDJ; BDJ is a mind-body intervention
Active Comparator: Exercise + sham tDCS	Device: sham tDCS; sham tDCS; Other: exercise; exercise including stretching and other activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
M1 resting state functional connectivity	Changes in brain resting-state connectivity between the primary motor cortex (M1) and other brain regions pre- and post-treatments, analyzed using the CONN Toolbox (https://web.conn-toolbox.org/)	Baseline, post-treatment (12 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change on M1 corticospinal excitability and cortico-cortical excitability	M1 corticospinal excitability will be measured using motor threshold, motor evoked potential, short-interval intracortical inhibition (SICI) and intracortical facilitation (ICF).	Baseline, post-treatment (12 weeks)
Change on brain gray matter volume	Voxel-based morphometry (VBM) analysis will be performed to investigate gray matter volume changes.	Baseline, post-treatment (12 weeks)
Change on Knee Injury and Osteoarthritis Outcome Score (KOOS)	The KOOS is a 35-item self-administered survey of pain and function in knee OA patients.	Baseline, post-treatment (12 weeks), follow-up (24 weeks)
Change on Patient-Reported Outcomes Measurement Information System (PROMIS)-29	We will use PROMIS-29 to assess pain, function, depression, anxiety, and sleep in the past 7 days.	Baseline, post-treatment (12 weeks), follow-up (24 weeks)
change on Beck's Depression Inventory (BDI-II)	BDI-II is designed for individuals aged 13 and over and is composed of items relating to symptoms of depression.	Baseline, post-treatment (12 weeks), follow-up (24 weeks)
Change on Pain Catastrophizing Scale (PCS)	PCS is a 15-item questionnaire used to characterize an individual's tendency to magnify the threat value of a pain experience and to feel helpless in the presence of pain.	Baseline, post-treatment (12 weeks), follow-up (24 weeks)
Change on Quantitative Sensory Testing (QST)	Pressure pain thresholds will be assessed 3 times using a Somedic digital pressure algometer. Contact heat stimuli will be delivered using a PATHWAY CHEPS (Contact Heat-Evoked Potential Stimulator, Medoc Advanced Medical Systems).	Baseline, post-treatment (12 weeks), follow-up (24 weeks)
Change on 6-Minute Walk Test	The 6-Minute Walk Test is a self-paced endurance test that assesses walking ability and endurance and includes standardized encouragement that increase tolerability in elders and those with physical impairment.	Baseline, post-treatment (12 weeks), follow-up (24 weeks)
Change on Cerebral blood flow	Cerebral blood flow will be measured using arterial spin labeling (ASL)	Baseline, post-treatment (12 weeks)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2024
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: April 19, 2023
• First Submitted That Met QC Criteria: May 1, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Behavioral Disciplines and Activities; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Electroshock; Psychological Techniques; Exercise; Transcranial Direct Current Stimulation
• Other Study ID Numbers: 2023P000908

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No