Enhancing Modulation Effects of Baduanjin Through Neuromodulation for Knee OA

May 1, 2023 updated by: Jian Kong, Massachusetts General Hospital

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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 [292];
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

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
Change on functional connectivity of the bilateral M1.
Time Frame: Baseline, post-treatment (12 weeks)
Resting state connections between the primary motor area (M1) and other brain regions
Baseline, post-treatment (12 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change on cerebral blood flow
Time Frame: Baseline, post-treatment (12 weeks)
Cerebral blood flow will be measured using arterial spin labeling (ASL)
Baseline, post-treatment (12 weeks)
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).
Baseline, post-treatment (12 weeks)
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.
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)
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
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.
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)
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)
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.
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)
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
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.
Baseline, post-treatment (12 weeks), follow-up (24 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2023

Primary Completion (Anticipated)

March 30, 2028

Study Completion (Anticipated)

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)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 1, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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