Clinical trial NCT04733352: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acupuncture Therapy
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: National Health Research Institutes, Taiwan
First posted: 2021-02-02
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: the expressed differences of the genes of the two acupuncture groups.
timeFrame: through study completion, an average of 1 year
measure: the expressed differences of the proteins of the two acupuncture groups.
timeFrame: through study completion, an average of 1 year
measure: the expressed differences of the metabolites of the two acupuncture groups.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Assessment of Radial Pressure Pulse-wave
timeFrame: 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
measure: Assessment of meridian energy
timeFrame: 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
measure: Range of knee motion
timeFrame: 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)
measure: Visual analog scale (VAS)
timeFrame: 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)
measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 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)
measure: The survey of Chinese medical body constitution
timeFrame: 30 min before the first acupuncture treatment
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: Yiyuantang Chinese Medicine Clinic
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Yu-Chen Lee, M.D. & Ph.D.
role: STUDY_DIRECTOR
References: