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Tai Chi for Knee OA Pain Management: a Mechanistic Study

Primary Purpose

Knee Osteoarthritis, Mind-body Exercise

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tai chi exercise
Sponsored by
Texas Tech University Health Sciences Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Postmenopausal women.
  2. WOMAC pain score ≥ 50 on at least 1 of the 5 questions in pain subscale (range of 0 to 100, with higher scores indicating greater pain.
  3. English literacy.
  4. Able to undergo an MRI scan
  5. Diagnosed Have the following symptoms associated with knee OA based on American College of Rheumatology clinical classification criteria for osteoarthritis (Peat 2006). Pain in the knee. Need to at least 3 of the following: over 50 years of age, less than 30 minutes of morning stiffness, crepitus on active motion, bony tenderness, bony enlargement, or no palpable warmth of synovium.

Exclusion Criteria:

  1. Prior experience with mind-body practice (e.g. TC, Qi Gong, yoga, or acupuncture) or physical therapy programs for knee OA within the past 3 months.
  2. Severe medical limitations (i.e., dementia, symptomatic heart or vascular disease, or recent stroke) precluding full participation.
  3. Medical/neurologic or other systemic diseases affecting the musculoskeletal systems (i.e. polio/Parkinson's/multiple sclerosis, etc. in addition to cerebral vascular accident or stroke) and diabetes with peripheral neuropathy affecting their sensory/balance.
  4. Intra-articular steroid injection or reconstructive surgery on most severely affected knee in the past three months.
  5. Intra-articular hyaluronic acid injections on most severely affected knee in the past six months.
  6. Inability to walk without an assistive device.

Sites / Locations

  • Texas Tech University Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tai Chi intervention

Arm Description

24-form Yang style Tai Chi

Outcomes

Primary Outcome Measures

endocannabinoid
plasma endocannabinoid levels
oxylipins
plasma oxylipins levels

Secondary Outcome Measures

endocannabinoid receptors expression
expression of endocannabinoids receptors on peripheral blood mononuclear cells using flow cytometry. Collect venous blood into evacuated tube containing lithium heparin and pour into a Leucosep tube prepared with Ficoll-Paque. Following sequential centrifugation steps, peripheral blood mononuclear cells will be collected and incubate with endotoxin (e.g. LPS or PMA) for 24 hours (Venable 2016). After incubation, PBMC will be collected and stained with cannabinoid receptors (CB1R and CB2R) and markers for monocytes/macrophages (CD14, etc).
BDNF
plasma brain-derived neurotrophic factor levels using ELISA
white matter connectivity/efficiency of various fiber tracts in the brain
We will follow the protocol of Vachon-Presseau et al. 2006 to collect DTI data. DTI images will be acquired using echo planar imaging (72 x 2-mm thick axial slices; matrix size = 128 x 128; field of view = 256 x 256mm2, resulting in a voxel size of 2 x 2 x 2mm). Images will have an isotropic distribution along 60 directions using a b-value of 1000s/mm2. For each set of diffusion-weighted data, eight volumes with no diffusion weighting will be acquired at equidistant points throughout the acquisition.
pain sensitivity
We will use quantitative sensory test including windup to assess pain sensitivity in the most painful knee of subject
Pain assessment
We will use Brief Pain Inventory (questionnaire) for pain assessment.
physical function
We will use WOAMC questionnaire for physical function assessment
Quality of life assessment
Quality of life status will be assessed with the Medical Outcomes Study 36-item short form Health Survey (SF-36, version 2), which consists of eight dimensions of health (physical function, bodily pain, general health, vitality, mental health, social function, and role of physical and emotional health) in the conduct of daily activity characteristics will be assessed with self-report SF-36 questionnaires related to self-rated health, depression, anxiety and sleep quality.

Full Information

First Posted
July 26, 2019
Last Updated
February 17, 2023
Sponsor
Texas Tech University Health Sciences Center
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1. Study Identification

Unique Protocol Identification Number
NCT04046003
Brief Title
Tai Chi for Knee OA Pain Management: a Mechanistic Study
Official Title
Tai Chi for Pain Management of Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University Health Sciences Center

4. Oversight

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

5. Study Description

Brief Summary
This study is to determine how 8-week Tai Chi intervention alters plasma endocannabinoid and its receptors in monocytes/marcrophages, plasma oxylipinds, plasma brain-derived neurotrophic factor, brain white matter connectivity/efficiency, and functional/clinical outcomes in women with knee OA.
Detailed Description
Knee osteoarthritis (OA) is one of the five leading causes of disability. Previous studies have shown that a mind-body moderate-intensity Tai Chi (TC) exercise (8-24 weeks) reduced pain and improved physical function for knee OA, when compared to a waiting list, attention control, usual physical activity, or physical therapy. However, TC's mechanisms of action regarding improvement of one's clinical condition and its functional outcomes in individuals with knee OA are poorly understood. This study is to determine how 8-week TC intervention alters plasma endocannabinoid and its receptors in monocytes/marcrophages, plasma oxylipinds, plasma brain-derived neurotrophic factor, brain white matter connectivity/efficiency, and functional/clinical outcomes in women with knee OA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Mind-body Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
24-form Yang style Tai Chi (60 min/session, 3 sessions/week) for 8 weeks.
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tai Chi intervention
Arm Type
Experimental
Arm Description
24-form Yang style Tai Chi
Intervention Type
Behavioral
Intervention Name(s)
Tai chi exercise
Intervention Description
24-form Yang style Tai Chi (60 min/session, 3 sessions/week) for 8 weeks
Primary Outcome Measure Information:
Title
endocannabinoid
Description
plasma endocannabinoid levels
Time Frame
Changes from bseline endocannabinoid levels at 8 weeks
Title
oxylipins
Description
plasma oxylipins levels
Time Frame
Changes from baseline oxylipins levels at 8 weeks
Secondary Outcome Measure Information:
Title
endocannabinoid receptors expression
Description
expression of endocannabinoids receptors on peripheral blood mononuclear cells using flow cytometry. Collect venous blood into evacuated tube containing lithium heparin and pour into a Leucosep tube prepared with Ficoll-Paque. Following sequential centrifugation steps, peripheral blood mononuclear cells will be collected and incubate with endotoxin (e.g. LPS or PMA) for 24 hours (Venable 2016). After incubation, PBMC will be collected and stained with cannabinoid receptors (CB1R and CB2R) and markers for monocytes/macrophages (CD14, etc).
Time Frame
Changes from baseline the affinity of endocannabinoid receptor expression at 8 weeks
Title
BDNF
Description
plasma brain-derived neurotrophic factor levels using ELISA
Time Frame
Changes from baseline BDNF levels at 8 weeks
Title
white matter connectivity/efficiency of various fiber tracts in the brain
Description
We will follow the protocol of Vachon-Presseau et al. 2006 to collect DTI data. DTI images will be acquired using echo planar imaging (72 x 2-mm thick axial slices; matrix size = 128 x 128; field of view = 256 x 256mm2, resulting in a voxel size of 2 x 2 x 2mm). Images will have an isotropic distribution along 60 directions using a b-value of 1000s/mm2. For each set of diffusion-weighted data, eight volumes with no diffusion weighting will be acquired at equidistant points throughout the acquisition.
Time Frame
Change from baselinewhite matter connectivity/efficiency of various fiber tracts in the brain at 8 weeks
Title
pain sensitivity
Description
We will use quantitative sensory test including windup to assess pain sensitivity in the most painful knee of subject
Time Frame
Change from baseline pain sensitivity scale at 8 weeks
Title
Pain assessment
Description
We will use Brief Pain Inventory (questionnaire) for pain assessment.
Time Frame
Change from baseline pain scale at 8 weeks
Title
physical function
Description
We will use WOAMC questionnaire for physical function assessment
Time Frame
Changes from baseline WOMAC results at 8 weeks
Title
Quality of life assessment
Description
Quality of life status will be assessed with the Medical Outcomes Study 36-item short form Health Survey (SF-36, version 2), which consists of eight dimensions of health (physical function, bodily pain, general health, vitality, mental health, social function, and role of physical and emotional health) in the conduct of daily activity characteristics will be assessed with self-report SF-36 questionnaires related to self-rated health, depression, anxiety and sleep quality.
Time Frame
Changes from baseline SF-36 results at 8 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Postmenopausal women.
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Postmenopausal women. WOMAC pain score ≥ 50 on at least 1 of the 5 questions in pain subscale (range of 0 to 100, with higher scores indicating greater pain. English literacy. Able to undergo an MRI scan Diagnosed Have the following symptoms associated with knee OA based on American College of Rheumatology clinical classification criteria for osteoarthritis (Peat 2006). Pain in the knee. Need to at least 3 of the following: over 50 years of age, less than 30 minutes of morning stiffness, crepitus on active motion, bony tenderness, bony enlargement, or no palpable warmth of synovium. Exclusion Criteria: Prior experience with mind-body practice (e.g. TC, Qi Gong, yoga, or acupuncture) or physical therapy programs for knee OA within the past 3 months. Severe medical limitations (i.e., dementia, symptomatic heart or vascular disease, or recent stroke) precluding full participation. Medical/neurologic or other systemic diseases affecting the musculoskeletal systems (i.e. polio/Parkinson's/multiple sclerosis, etc. in addition to cerebral vascular accident or stroke) and diabetes with peripheral neuropathy affecting their sensory/balance. Intra-articular steroid injection or reconstructive surgery on most severely affected knee in the past three months. Intra-articular hyaluronic acid injections on most severely affected knee in the past six months. Inability to walk without an assistive device.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chwan-Li Shen
Organizational Affiliation
Texas Tech University Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Tech University Health Sciences Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Tai Chi for Knee OA Pain Management: a Mechanistic Study

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