Enhancing Modulation Effects of Baduanjin Through Neuromodulation for Knee OA

Phase 2

Recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Behavioral: BDJ; Device: tDCS; Other: exercise; Device: sham tDCS

• Registration Number: NCT05839535
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-19
• Study First Submitted QC: 2023-05-01
• Study First Posted: 2023-05-03
• Study Start: 2024-03-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Primary Completion: 2028-03-30
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BDJ + real tDCS	BDJ	-
BDJ + real tDCS	tDCS	-
Exercise + real tDCS	exercise	-
Exercise + sham tDCS	exercise	-
Exercise + real tDCS	tDCS	-
BDJ + sham tDCS	BDJ	-
BDJ + sham tDCS	sham tDCS	-
Exercise + sham tDCS	sham tDCS	-

Primary Outcome Measures

Name	Time	Method
M1 resting state functional connectivity	Baseline, post-treatment (12 weeks)	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/)

Secondary Outcome Measures

Name	Time	Method
Change on Knee Injury and Osteoarthritis Outcome Score (KOOS)	Baseline, post-treatment (12 weeks), follow-up (24 weeks)	The KOOS is a 35-item self-administered survey of pain and function in knee OA patients.
Change on brain gray matter volume	Baseline, post-treatment (12 weeks)	Voxel-based morphometry (VBM) analysis will be performed to investigate gray matter volume changes.
Change on Cerebral blood flow	Baseline, post-treatment (12 weeks)	Cerebral blood flow will be measured using arterial spin labeling (ASL)
Change on M1 corticospinal excitability and cortico-cortical excitability	Baseline, post-treatment (12 weeks)	M1 corticospinal excitability will be measured using motor threshold, motor evoked potential, short-interval intracortical inhibition (SICI) and intracortical facilitation (ICF).
Change on 6-Minute Walk Test	Baseline, post-treatment (12 weeks), follow-up (24 weeks)	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.
Change on Pain Catastrophizing Scale (PCS)	Baseline, post-treatment (12 weeks), follow-up (24 weeks)	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.
Change on Quantitative Sensory Testing (QST)	Baseline, post-treatment (12 weeks), follow-up (24 weeks)	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).
Change on Patient-Reported Outcomes Measurement Information System (PROMIS)-29	Baseline, post-treatment (12 weeks), follow-up (24 weeks)	We will use PROMIS-29 to assess pain, function, depression, anxiety, and sleep in the past 7 days.
change on Beck's Depression Inventory (BDI-II)	Baseline, post-treatment (12 weeks), follow-up (24 weeks)	BDI-II is designed for individuals aged 13 and over and is composed of items relating to symptoms of depression.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Charlestown, Massachusetts, United States