Enhancing Modulation Effects of Baduanjin Through Neuromodulation for Knee OA

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05839535
• Other study ID #: 2023P000908
• Status: Recruiting
• Phase: Phase 2
• Start date: March 5, 2024
• Est. completion date: August 31, 2028

Study information

• Verified date: April 2024
• Source: Massachusetts General Hospital
• Contact: Jian Kong
• Phone: 617-7267893
• Email: jkong2[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: August 31, 2028
• Est. primary completion date: March 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• BDJ
BDJ is a mind-body intervention

Device:
• tDCS
tDCS is a brain stimulation method.
• sham tDCS
sham tDCS

Other:
• exercise
exercise including stretching and other activities.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Charlestown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change on Cerebral blood flow	Cerebral blood flow will be measured using arterial spin labeling (ASL)	Baseline, post-treatment (12 weeks)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)