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Recruiting NCT05839535

Enhancing Modulation Effects of Baduanjin Through Neuromodulation for Knee OA

Phase II Interventional Knee Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BDJ, tDCS, sham tDCS, exercise.
Who it may be relevant to
Registry conditions: Knee Osteoarthritis. Basic parameters: 45 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral BDJ
    BDJ is a mind-body intervention
  • Device tDCS
    tDCS is a brain stimulation method.
  • Device sham tDCS
    sham tDCS
  • Other exercise
    exercise including stretching and other activities.

Primary outcome measures

  • M1 resting state functional connectivity [Time frame: Baseline, post-treatment (12 weeks)]
Secondary outcome measures (9)
  • Change on Cerebral blood flow [Time frame: Baseline, post-treatment (12 weeks)]
  • Change on M1 corticospinal excitability and cortico-cortical excitability [Time frame: Baseline, post-treatment (12 weeks)]
  • Change on brain gray matter volume [Time frame: Baseline, post-treatment (12 weeks)]
  • Change on Knee Injury and Osteoarthritis Outcome Score (KOOS) [Time frame: Baseline, post-treatment (12 weeks), follow-up (24 weeks)]
  • Change on Patient-Reported Outcomes Measurement Information System (PROMIS)-29 [Time frame: Baseline, post-treatment (12 weeks), follow-up (24 weeks)]
  • change on Beck's Depression Inventory (BDI-II) [Time frame: Baseline, post-treatment (12 weeks), follow-up (24 weeks)]
  • Change on Pain Catastrophizing Scale (PCS) [Time frame: Baseline, post-treatment (12 weeks), follow-up (24 weeks)]
  • Change on Quantitative Sensory Testing (QST) [Time frame: Baseline, post-treatment (12 weeks), follow-up (24 weeks)]
  • Change on 6-Minute Walk Test [Time frame: Baseline, post-treatment (12 weeks), follow-up (24 weeks)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

United States · 1 center
  • Massachusetts General Hospital — Charlestown

Identifiers

NCT: NCT05839535 · 2023P000908

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗