Acupuncture TherapyNCT04733352
Using Omics Technology to Explore the Mechanism of Acupuncture Treatment of Different Acupoints of Knee Osteoarthritis
A study testing acupuncture in people with Acupuncture Therapy, run by China Medical University Hospital at 2 sites in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acupuncture Therapy
- What is being tested?
- acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTaiwan
- Study dates
- 12 Oct 2020to 12 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Yiyuantang Chinese Medicine Clinic
Hsinchu
China Medical University Hospital
Taichung, 404
About this study
Official title: Using Omics Technology to Explore the Mechanism of Acupuncture Treatment of Different Acupoints of Knee Osteoarthritis: a Randomized Controlled Trial
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.
Read the 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
- Being tested
- acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
to conduct acupuncture on different acupoints
| Study group | Role | What they receive |
|---|---|---|
| proximal acupoints of knees | Experimental | GB34, SP9, and EX-LE2 Receives: Other: acupuncture |
| distal acupoints of knees | Experimental | LI11, HT3, and TE10 Receives: Other: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
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.
Measured: 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
Assessment of the energy of twelve meridians before and after the intervention using Ryodoraku.
Measured: 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
Range of knee motion will be examined by a goniometer.
Measured: 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)
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)
Measured: 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)
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.
Measured: 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 survey of Chinese medical body constitution
The scores of the Chinese medical body constitution can tell the difference of the subjects' physical fitness.
Measured: 30 min before the first acupuncture treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start12 Oct 2020
- Primary completion31 May 2021
- Study completion12 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acupuncture TherapyStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Responsible party
- Principal investigator, Yu-Chen Lee, China Medical University Hospital
- Investigators
- Yu-Chen Lee, M.D. & Ph.D., Study director, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733352
- Sponsor's protocol ID
- CMUH109-REC3-113
- Status last verified
- Jan 2024
- First submitted
- 9 Oct 2020
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Omics Technology to Explore the Mechanism of Acupuncture Treatment of Different Acupoints of Knee Osteoarthritis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04733352
- Acronym / sponsor ID
- CMUH109-REC3-113
- Conditions
- Acupuncture Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 12 Sep 2021 (actual)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| proximal acupoints of knees | Experimental | Other: acupunctureGB34, SP9, and EX-LE2 |
| distal acupoints of knees | Experimental | Other: acupunctureLI11, HT3, and TE10 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureto conduct acupuncture on different acupoints | Other | distal acupoints of knees, proximal acupoints of knees |
Primary outcome
the expressed differences of the genes of the two acupuncture groups.
Time frame: through study completion, an average of 1 year
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.
Time frame: through study completion, an average of 1 year
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.
Time frame: through study completion, an average of 1 year
The blood samples will be collected 4 times and analyzed which type of metabolites by LC-MS/MS.
6 secondary outcomes
Assessment of Radial Pressure Pulse-wave
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
Assessment of meridian energy
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
Range of knee motion
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)
Visual analog scale (VAS)
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)
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
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)
The survey of Chinese medical body constitution
Time frame: 30 min before the first acupuncture treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Acupuncture Therapy
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
Recruiting
Acupuncture for ADHD: Acupoint Data Mining, Clinical Effectiveness, and Interviews to Explore Treatment Outcomes.
Acupuncture, ADHD - Attention Deficit Disorder With Hyperactivity
Active, not recruiting
The Acupuncture Treatment Effect in Patients With Schizophrenia
Mental Health
Recruiting
Clinical Trial for Acupuncture in Adolescents With Psychological Distress and Insomnia
Psychological Distress, Insomnia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Chen Lee, M.D. & Ph.D. study director
China Medical University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Acupuncture Therapy, run by China Medical University Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the expressed differences of the genes of the two acupuncture groups. (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.