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

NCT04733352 | Completed DMC

• 1 other identifier: CMUH109-REC3-113
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Acupuncture Therapy

Outcome Measures

Primary Outcomes (3)

• 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.

  through study completion, an average of 1 year

• 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

  through study completion, an average of 1 year

• 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.

  through study completion, an average of 1 year

Secondary Outcomes (6)

• Assessment of Radial Pressure Pulse-wave

  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

• Assessment of meridian energy

  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

• Range of knee motion

  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)

• Visual analog scale (VAS)

  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)

• The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  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)

Study Arms (2)

proximal acupoints of knees

EXPERIMENTAL

GB34, SP9, and EX-LE2

Other: acupuncture

distal acupoints of knees

EXPERIMENTAL

LI11, HT3, and TE10

Other: acupuncture

Interventions

acupuncture OTHER

to conduct acupuncture on different acupoints

distal acupoints of knees; proximal acupoints of knees

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead
• National Health Research Institutes, Taiwan: collaborator

Study Sites (2)

Yiyuantang Chinese Medicine Clinic

Hsinchu, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Yu-Chen Lee, M.D. & Ph.D.

  China Medical University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, department of acupuncture

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: February 2, 2021
• Study Start: October 12, 2020
• Primary Completion: May 31, 2021
• Study Completion: September 12, 2021
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)