Using Omics Technology to Explore the Mechanism of Acupuncture Treatment of Different Acupoints of Knee Osteoarthritis
Primary Purpose
Acupuncture Therapy
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Acupuncture Therapy
Eligibility Criteria
Inclusion Criteria:
Subjects will be recruited when they meet the Clinical Classification Criteria for KOA, that is knee pain and three out of six symptoms can be found in clinical practices, as recommended by the American College of Rheumatology:
- any gender aged 50 years or above;
- have less than 30 minutes of morning stiffness;
- crepitus on active motion;
- bony tenderness;
- bony enlargement;
- no palpable warmth.
Exclusion Criteria:
- Subjects with malignancy, any acute medical condition, poorly controlled diabetes or hypertension, a motor or sensory nerve defect, blood clotting disease, mental illness, dementia, mental retardation or other abnormal person on the organic mind.
- Subjects with intra-articular solid or hyaluronic acid injection in the past 3 months.
- Subjects have undergone knee surgery, knee trauma, congenital knee deformation, severe knee varus or valgus deformation, or endocrine, metabolic, infectious, inflammatory, secondary degenerative knee arthritis caused by problems with rheumatic immune diseases.
- unable to walk.
- Subjects who are hypersensitive to needles.
- Those who are unwilling to cooperate and sign the subject's consent form after explaining and explaining the clinical trial process and purpose.
Sites / Locations
- Yiyuantang Chinese Medicine ClinicRecruiting
- China Medical University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
proximal acupoints of knees
distal acupoints of knees
Arm Description
GB34, SP9, and EX-LE2
LI11, HT3, and TE10
Outcomes
Primary Outcome Measures
the expressed differences of the genes of the two acupuncture groups.
The blood samples will be collected 4 times and analyzed which type of gene by quantitative real time-PCR.
the expressed differences of the proteins of the two acupuncture groups.
The blood samples will be collected 4 times and analyzed which type of proteins by Micro-Western Array
the expressed differences of the metabolites of the two acupuncture groups.
The blood samples will be collected 4 times and analyzed which type of metabolites by LC-MS/MS.
Secondary Outcome Measures
Assessment of Radial Pressure Pulse-wave
Assessment of Radial Pressure Pulse-wave at Cun, Guan & Chi of both hands before and after the intervention using Pulse Sphygmograph.
Assessment of meridian energy
Assessment of the energy of twelve meridians before and after the intervention using Ryodoraku.
Range of knee motion
Range of knee motion will be examined by a goniometer.
Visual analog scale (VAS)
The intensity of pain is measure using VAS for pain. It is incorporated into the questionnaire with a scale of 0 (no pain) to 10 (worst pain possible)
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
A questionnaire developed to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints.
The survey of Chinese medical body constitution
The scores of the Chinese medical body constitution can tell the difference of the subjects' physical fitness.
Full Information
NCT ID
NCT04733352
First Posted
October 9, 2020
Last Updated
January 27, 2021
Sponsor
China Medical University Hospital
Collaborators
National Health Research Institutes, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT04733352
Brief Title
Using Omics Technology to Explore the Mechanism of Acupuncture Treatment of Different Acupoints of Knee Osteoarthritis
Official Title
Using Omics Technology to Explore the Mechanism of Acupuncture Treatment of Different Acupoints of Knee Osteoarthritis: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 12, 2020 (Actual)
Primary Completion Date
October 11, 2021 (Anticipated)
Study Completion Date
October 11, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University Hospital
Collaborators
National Health Research Institutes, Taiwan
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
In recent years, commonly used Omics techniques, including genomics, proteomics, metabolomics, have been applied in the studies on the mechanism of acupuncture effect. In the previous study, "Immediate effects of proximal and distal acupoints on the Radial Pressure Pulse-wave in patients with knee osteoarthritis: a randomized controlled trial", significant changes in the spectral-energy of the pulse wave in the proximal-acupoint treatment group and the distal-acupoint treatment group infer pain relief and blood-flow improvement. The scores of the Visual Analog Scale were decreased, and the passive and active range of knee motions were increased. Both of the proximal and distant acupoints could be used for knee osteoarthritis treatment. To advance the previous work by becoming one treatment, this study will explore if there is any Omics difference resulting from the two acupoints, thus examining the mechanism of curative effect of acupuncture. Additionally, Chinese medical emphasizes the relationship between body constitution and diseases and the dynamic change of pulses and meridians during the disease development. These significances are in agreement with Omics features about organism integrity, dynamic, and complexity. The current study will adopt a Chinese medical body constitution survey, the spectral-energy (SE) changes of the pressure wave from the radial artery, and the pulse energy analysis of Ryodoraku to identify the differences in specific genes, protein, and metabolites of various body constitutions, pulses, changes of the pressure wave, aiming to set up the objectification of Chinese medical diagnosis.
Detailed Description
Introduction:
In recent years, commonly used Omics techniques, including genomics, proteomics, metabolomics, have been applied in the studies on the mechanism of acupuncture effect. In the previous study, "Immediate effects of proximal and distal acupoints on the Radial Pressure Pulse-wave in patients with knee osteoarthritis: a randomized controlled trial", significant changes in the spectral-energy of the pulse wave in the proximal-acupoint treatment group and the distal-acupoint treatment group infer pain relief and blood-flow improvement. The scores of the Visual Analog Scale were decreased, and the passive and active range of knee motions were increased. Both of the proximal and distant acupoints could be used for knee osteoarthritis treatment. To advance the previous work by becoming one treatment, this study will explore if there is any Omics difference resulting from the two acupoints, thus examining the mechanism of curative effect of acupuncture. Additionally, Chinese medical emphasizes the relationship between body constitution and diseases and the dynamic change of pulses and meridians during the disease development. These significances are in agreement with Omics features about organism integrity, dynamic, and complexity. The current study will adopt a Chinese medical body constitution survey, the spectral-energy (SE) changes of the pressure wave from the radial artery, and the pulse energy analysis of Ryodoraku to identify the differences in specific genes, protein, and metabolites of various body constitutions, pulses, changes of the pressure wave, aiming to set up the objectification of Chinese medical diagnosis.
Method:
The study will recruit 60 participants, which will be recruited when they meet the Clinical Classification Criteria for KOA, that is knee pain and three out of six symptoms can be found in clinical practices, as recommended by the American College of Rheumatology:(a) any gender aged 50 years or above;(b) have less than 30 minutes of morning stiffness; (c) crepitus on active motion; and (d) bony tenderness;(e) bony enlargement; and (f) no palpable warmth. They will be randomly assigned to two groups: the distal-acupoint treatment group (DG) (LI11, HT3 and TE10 and the proximal-acupoint treatment group (PG) (GB34, SP9 and EX-LE2). The study will last for five weeks. Each week has two sessions, as a total of ten sessions. The participants will have blood tests in the following times: before the first acupuncture, after the fifth acupuncture and the tenth acupuncture, three weeks after the end of treatment. The study design is random and single-blind. The participants The primary outcome will come from the assessment: comparing the expressed differences of the genes, proteins, and metabolites of the two acupoints. The secondary outcome will be from the connection among 1) the expressed differences of the specific genes, proteins, 2) the survey of Chinese medical body constitution, 3) the spectral-energy (SE) changes of the pressure wave from the radial artery, and 4) the Ryodoraku pulse energy.
Expected outcome:
The study will use the principle and techniques of Omics to explore the mechanism of the curative effect caused by acupuncture on different acupoints. It is expected to serve as a bridge to connect between contemporary medical and traditional medical.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acupuncture Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
proximal acupoints of knees
Arm Type
Experimental
Arm Description
GB34, SP9, and EX-LE2
Arm Title
distal acupoints of knees
Arm Type
Experimental
Arm Description
LI11, HT3, and TE10
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
to conduct acupuncture on different acupoints
Primary Outcome Measure Information:
Title
the expressed differences of the genes of the two acupuncture groups.
Description
The blood samples will be collected 4 times and analyzed which type of gene by quantitative real time-PCR.
Time Frame
through study completion, an average of 1 year
Title
the expressed differences of the proteins of the two acupuncture groups.
Description
The blood samples will be collected 4 times and analyzed which type of proteins by Micro-Western Array
Time Frame
through study completion, an average of 1 year
Title
the expressed differences of the metabolites of the two acupuncture groups.
Description
The blood samples will be collected 4 times and analyzed which type of metabolites by LC-MS/MS.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Assessment of Radial Pressure Pulse-wave
Description
Assessment of Radial Pressure Pulse-wave at Cun, Guan & Chi of both hands before and after the intervention using Pulse Sphygmograph.
Time Frame
There are two sessions each week. The participants will be measured twice in each session. The first time is 10 minutes before the acupuncture treatment; the second time is 10 minutes later after the acupuncture treatment
Title
Assessment of meridian energy
Description
Assessment of the energy of twelve meridians before and after the intervention using Ryodoraku.
Time Frame
There are two sessions each week. The participants will be measured twice in each session. The first time is 15 minutes before the acupuncture treatment; the second time is 15 minutes later after the acupuncture treatment
Title
Range of knee motion
Description
Range of knee motion will be examined by a goniometer.
Time Frame
before the first session (which is in the first week), after the tenth session (which is in the fifth week), and the three weeks later after the end of the treatment (which is in the eighth week)
Title
Visual analog scale (VAS)
Description
The intensity of pain is measure using VAS for pain. It is incorporated into the questionnaire with a scale of 0 (no pain) to 10 (worst pain possible)
Time Frame
before the first session (which is in the first week), after the tenth session (which is in the fifth week), and the three weeks later after the end of the treatment (which is in the eighth week)
Title
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
A questionnaire developed to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints.
Time Frame
before the first session (which is in the first week), after the tenth session (which is in the fifth week), and the three weeks later after the end of the treatment (which is in the eighth week)
Title
The survey of Chinese medical body constitution
Description
The scores of the Chinese medical body constitution can tell the difference of the subjects' physical fitness.
Time Frame
30 min before the first acupuncture treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects will be recruited when they meet the Clinical Classification Criteria for KOA, that is knee pain and three out of six symptoms can be found in clinical practices, as recommended by the American College of Rheumatology:
any gender aged 50 years or above;
have less than 30 minutes of morning stiffness;
crepitus on active motion;
bony tenderness;
bony enlargement;
no palpable warmth.
Exclusion Criteria:
Subjects with malignancy, any acute medical condition, poorly controlled diabetes or hypertension, a motor or sensory nerve defect, blood clotting disease, mental illness, dementia, mental retardation or other abnormal person on the organic mind.
Subjects with intra-articular solid or hyaluronic acid injection in the past 3 months.
Subjects have undergone knee surgery, knee trauma, congenital knee deformation, severe knee varus or valgus deformation, or endocrine, metabolic, infectious, inflammatory, secondary degenerative knee arthritis caused by problems with rheumatic immune diseases.
unable to walk.
Subjects who are hypersensitive to needles.
Those who are unwilling to cooperate and sign the subject's consent form after explaining and explaining the clinical trial process and purpose.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Chen Lee, M.D. & Ph.D.
Phone
886-4-2205-2121
Ext
1670
Email
d5167@mail.cmuh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Chen Lee, M.D. & Ph.D.
Organizational Affiliation
China Medical University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Yiyuantang Chinese Medicine Clinic
City
Hsinchu
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wan-Zhen Yu
First Name & Middle Initial & Last Name & Degree
Yu-Chen Lee, M.D. & Ph.D.
Phone
886-4-2205-2121
Ext
1670
Email
d5167@mail.cmuh.org.tw
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Chen Lee, Ph.D.
Phone
+886-975-682-023
Email
d5167@mail.cmuh.org.tw
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Using Omics Technology to Explore the Mechanism of Acupuncture Treatment of Different Acupoints of Knee Osteoarthritis
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