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NCT Number: NCT05839535

Enhancing Modulation Effects of Baduanjin Through Neuromodulation for Knee OA

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.

Recruiting

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location status: Recruiting

Location contact

meixuan Zhu

CONTACT

[email protected]

617-726-5004

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BDJ

Behavioral

BDJ is a mind-body intervention

tDCS

Device

tDCS is a brain stimulation method.

Sham tDCS

Device

sham tDCS

Exercise

Other

exercise including stretching and other activities.

Primary outcomes

  1. M1 resting state functional connectivity

    Time frame: 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 outcomes

  1. Change on Cerebral blood flow

    Time frame: Baseline, post-treatment (12 weeks)

    Cerebral blood flow will be measured using arterial spin labeling (ASL)

  2. Change on M1 corticospinal excitability and cortico-cortical excitability

    Time frame: 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).

  3. Change on brain gray matter volume

    Time frame: Baseline, post-treatment (12 weeks)

    Voxel-based morphometry (VBM) analysis will be performed to investigate gray matter volume changes.

  4. Change on Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 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.

  5. Change on Patient-Reported Outcomes Measurement Information System (PROMIS)-29

    Time frame: 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.

  6. change on Beck's Depression Inventory (BDI-II)

    Time frame: 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.

  7. Change on Pain Catastrophizing Scale (PCS)

    Time frame: 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.

  8. Change on Quantitative Sensory Testing (QST)

    Time frame: 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).

  9. Change on 6-Minute Walk Test

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jian Kong

CONTACT

[email protected]

617-7267893

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
May 3, 2023
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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