Using Omics Technology to Explore the Mechanism of Acupuncture Treatment of Different Acupoints of Knee Osteoarthritis

NCT ID: NCT04733352

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-12
• Study Completion Date: 2021-09-12

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.

Conditions

Acupuncture Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

proximal acupoints of knees

GB34, SP9, and EX-LE2

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: OTHER

to conduct acupuncture on different acupoints

distal acupoints of knees

LI11, HT3, and TE10

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: OTHER

to conduct acupuncture on different acupoints

Interventions

acupuncture

to conduct acupuncture on different acupoints

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Health Research Institutes, Taiwan

OTHER

Sponsor Role: collaborator

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yu-Chen Lee

Director, department of acupuncture

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yu-Chen Lee, M.D. & Ph.D.

Role: STUDY_DIRECTOR

China Medical University Hospital

Locations

Yiyuantang Chinese Medicine Clinic

Hsinchu, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

CMUH109-REC3-113

Identifier Type: -

Identifier Source: org_study_id