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Enhancing Modulation Effects of Baduanjin Through Neuromodulation for Knee OA

Primary Purpose

Knee Osteoarthritis

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
BDJ
tDCS
sham tDCS
exercise
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    BDJ + real tDCS

    Exercise + real tDCS

    BDJ + sham tDCS

    Exercise + sham tDCS

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change on functional connectivity of the bilateral M1.
    Resting state connections between the primary motor area (M1) and other brain regions

    Secondary Outcome Measures

    Change on cerebral blood flow
    Cerebral blood flow will be measured using arterial spin labeling (ASL)
    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).
    Change on brain gray matter volume
    Voxel-based morphometry (VBM) analysis will be performed to investigate gray matter volume changes.
    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.
    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.
    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.
    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.
    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).
    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.

    Full Information

    First Posted
    April 19, 2023
    Last Updated
    May 1, 2023
    Sponsor
    Massachusetts General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05839535
    Brief Title
    Enhancing Modulation Effects of Baduanjin Through Neuromodulation for Knee OA
    Official Title
    Enhancing Modulation Effects of Baduanjin Through Non-invasive Neuromodulation for Knee Osteoarthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    March 30, 2028 (Anticipated)
    Study Completion Date
    August 31, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    140 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    BDJ + real tDCS
    Arm Type
    Active Comparator
    Arm Title
    Exercise + real tDCS
    Arm Type
    Active Comparator
    Arm Title
    BDJ + sham tDCS
    Arm Type
    Active Comparator
    Arm Title
    Exercise + sham tDCS
    Arm Type
    Active Comparator
    Intervention Type
    Behavioral
    Intervention Name(s)
    BDJ
    Intervention Description
    BDJ is a mind-body intervention
    Intervention Type
    Device
    Intervention Name(s)
    tDCS
    Intervention Description
    tDCS is a brain stimulation method.
    Intervention Type
    Device
    Intervention Name(s)
    sham tDCS
    Intervention Description
    sham tDCS
    Intervention Type
    Other
    Intervention Name(s)
    exercise
    Intervention Description
    exercise including stretching and other activities.
    Primary Outcome Measure Information:
    Title
    Change on functional connectivity of the bilateral M1.
    Description
    Resting state connections between the primary motor area (M1) and other brain regions
    Time Frame
    Baseline, post-treatment (12 weeks)
    Secondary Outcome Measure Information:
    Title
    Change on cerebral blood flow
    Description
    Cerebral blood flow will be measured using arterial spin labeling (ASL)
    Time Frame
    Baseline, post-treatment (12 weeks)
    Title
    Change on M1 corticospinal excitability and cortico-cortical excitability
    Description
    M1 corticospinal excitability will be measured using motor threshold, motor evoked potential, short-interval intracortical inhibition (SICI) and intracortical facilitation (ICF).
    Time Frame
    Baseline, post-treatment (12 weeks)
    Title
    Change on brain gray matter volume
    Description
    Voxel-based morphometry (VBM) analysis will be performed to investigate gray matter volume changes.
    Time Frame
    Baseline, post-treatment (12 weeks)
    Title
    Change on Knee Injury and Osteoarthritis Outcome Score (KOOS)
    Description
    The KOOS is a 35-item self-administered survey of pain and function in knee OA patients.
    Time Frame
    Baseline, post-treatment (12 weeks), follow-up (24 weeks)
    Title
    Change on Patient-Reported Outcomes Measurement Information System (PROMIS)-29
    Description
    We will use PROMIS-29 to assess pain, function, depression, anxiety, and sleep in the past 7 days.
    Time Frame
    Baseline, post-treatment (12 weeks), follow-up (24 weeks)
    Title
    change on Beck's Depression Inventory (BDI-II)
    Description
    BDI-II is designed for individuals aged 13 and over and is composed of items relating to symptoms of depression.
    Time Frame
    Baseline, post-treatment (12 weeks), follow-up (24 weeks)
    Title
    Change on Pain Catastrophizing Scale (PCS)
    Description
    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.
    Time Frame
    Baseline, post-treatment (12 weeks), follow-up (24 weeks)
    Title
    Change on Quantitative Sensory Testing (QST)
    Description
    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).
    Time Frame
    Baseline, post-treatment (12 weeks), follow-up (24 weeks)
    Title
    Change on 6-Minute Walk Test
    Description
    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.
    Time Frame
    Baseline, post-treatment (12 weeks), follow-up (24 weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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 [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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jian Kong
    Phone
    617-7267893
    Email
    jkong2@mgh.harvard.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Enhancing Modulation Effects of Baduanjin Through Neuromodulation for Knee OA

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