The Clinical Value of Acupoint SensitizationNCT03975140
The Preventive Value of Acupoint Sensitization Based on Stable Angina Pectoris
A study testing Hypersensitive acupoint group and Hyposensitive acupoint group in people with The Clinical Value of Acupoint Sensitization, run by West China Hospital at 1 site in China.
Trial summary
This study, taking stable angina pectoris as a research carrier, aims to explore the preventive value of acupoint sensitization by conducting a double-blind multi-center randomized controlled trial to compare the effect of stimulating acupoints with different sensitivity on the prevention of angina pectoris. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- The Clinical Value of Acupoint Sensitization
- What is being tested?
- Hypersensitive acupoint group and Hyposensitive acupoint group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 28 Feb 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stable angina pectoris and symptoms of chest pain
- The duration of onset was more than 3 months, and the number of angina attacks in the past month was not less than 2
- Not younger than 35 years old and not older than 80 years old
- Patients will participate in the study voluntarily and have signed the informed consent
Who cannot join
- Patients with mental retardation
- Patients were contraindicated or unable to complete acupoint sensitization test
- Patients with cardiovascular, digestive, urinary, respiratory, blood, nervous, endocrine system and other serious primary diseases
- Patients with bleeding, allergy constitution
- Patients with abnormal skin or peripheral nerve sensation, abnormal pain sensation, skin ulceration at the sensitization detection site
- Patients with unsatisfactory clinical treatment of hypertension and diabetes
Trial locations and contacts
1 site in 1 country.
China1 site
The West China Hospital of Sichuan university
Chengdu, Sichuan, 610041
About this study
This study, taking stable angina pectoris as a research carrier, aims to explore the preventive value of acupoint sensitization by conducting a double-blind multi-center randomized controlled trial to compare the effect of stimulating acupoints with different sensitivity on the prevention of angina pectoris.
After the inclusion of eligible patients, the pressure-pain threshold of disease-related acupoints will be detected by using Von Frey detector. Then, the patients will be randomly divided into experimental group and control group. The patients in experimental group will be given acupoints pressure on the five acupoints with the lowest pressure-pain threshold, while the patients in control group will be given acupoints pressure on the five acupoints with the five acupoints with the highest pressure-pain threshold. The two groups will be treated with acupoints pressure 12 times within 4 weeks. The patients will be evaluated three times at baseline, the end of treatment and four weeks after the end of treatment respectively, including angina attack frequency, CCS classification and SAQ score.
- Being tested
- Hypersensitive acupoint group, Hyposensitive acupoint group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypersensitive acupoint groupProcedure or surgery
The first five acupoints in the sensitization sequence were pressed using the traditional Chinese medicine acupoint pressing technique, and each acupoint was pressed for two minutes.
Hyposensitive acupoint groupProcedure or surgery
The last five acupoints in the sensitization sequence were pressed using the traditional Chinese medicine acupoint pressing technique, and each acupoint was pressed for two minutes.
| Study group | Role | What they receive |
|---|---|---|
| Hypersensitive acupoint group | Experimental | Not described Receives: Procedure: Hypersensitive acupoint group |
| Hyposensitive acupoint group | Active comparator | Not described Receives: Procedure: Hyposensitive acupoint group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the number of angina attacks
Change of the number of uncomfortable events that met the criteria for angina in study period
Measured: Change from baseline to week 8
Secondary outcomes (3)
Change of the Canadian Cardiology Society (CCS) Classification of Angina Pectoris
According to the patient's own condition scale, the patients were divided into 4 grades, the mildest being grade I and the most serious being grade IV
Measured: Change from baseline to week 8
Change of the Seattle Angina Questionnaire(SAQ) Score
The maximum score of the scale was 100, and the higher the score, the better the quality of life and the functional state of the patients
Measured: Change from baseline to week 8
Change of the use of Therapeutic Nitroglycerin Drugs
Change of the number of times that patients temporarily took nitroglycerin for angina attacks
Measured: Change from baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 Jun 2019
- Primary completion22 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for The Clinical Value of Acupoint SensitizationStudies of the same condition, open and under way.
- More trials run by West China 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Xin, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975140
- Sponsor's protocol ID
- 81590955
- Status last verified
- Mar 2021
- First submitted
- 24 May 2019
- Last updated
- 30 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang S, Li L, Liu J, Li X, Shi Q, Li Y, Liu Y, Li M, Ma L, Ning L, Liao X, Ying X, Cai W, Yang F, Wang T, Guo R, Ma W, Chen W, Chen J, Sun X. The Preventive Value of Acupoint Sensitization for Patients with Stable Angina Pectoris: A Randomized, Double-Blind, Positive-Controlled, Multicentre Trial. Evid Based Complement Alternat Med. 2021 Nov 2;2021:7228033. doi: 10.1155/2021/7228033. eCollection 2021.
PubMed 34765004
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Preventive Value of Acupoint Sensitization Based on Stable Angina Pectoris
- ClinicalTrials.gov ID
- NCT03975140
- Acronym / sponsor ID
- 81590955
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 22 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 5 Jun 2019 (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.
This study, taking stable angina pectoris as a research carrier, aims to explore the preventive value of acupoint sensitization by conducting a double-blind multi-center randomized controlled trial to compare the effect of stimulating acupoints with different sensitivity on the prevention of angina pectoris.
After the inclusion of eligible patients, the pressure-pain threshold of disease-related acupoints will be detected by using Von Frey detector. Then, the patients will be randomly divided into experimental group and control group. The patients in experimental group will be given acupoints pressure on the five acupoints with the lowest pressure-pain threshold, while the patients in control group will be given acupoints pressure on the five acupoints with the five acupoints with the highest pressure-pain threshold. The two groups will be treated with acupoints pressure 12 times within 4 weeks. The patients will be evaluated three times at baseline, the end of treatment and four weeks after the end of treatment respectively, including angina attack frequency, CCS classification and SAQ score.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypersensitive acupoint group | Experimental | Procedure: Hypersensitive acupoint group |
| Hyposensitive acupoint group | Active comparator | Procedure: Hyposensitive acupoint group |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with stable angina pectoris and symptoms of chest pain
- The duration of onset was more than 3 months, and the number of angina attacks in the past month was not less than 2
- Not younger than 35 years old and not older than 80 years old
- Patients will participate in the study voluntarily and have signed the informed consent
Key exclusion criteria (6 listed)
- Patients with mental retardation
- Patients were contraindicated or unable to complete acupoint sensitization test
- Patients with cardiovascular, digestive, urinary, respiratory, blood, nervous, endocrine system and other serious primary diseases
- Patients with bleeding, allergy constitution
- Patients with abnormal skin or peripheral nerve sensation, abnormal pain sensation, skin ulceration at the sensitization detection site
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 |
|---|---|---|
| Hypersensitive acupoint groupThe first five acupoints in the sensitization sequence were pressed using the traditional Chinese medicine acupoint pressing technique, and each acupoint was pressed for two minutes. | Procedure or surgery | Hypersensitive acupoint group |
| Hyposensitive acupoint groupThe last five acupoints in the sensitization sequence were pressed using the traditional Chinese medicine acupoint pressing technique, and each acupoint was pressed for two minutes. | Procedure or surgery | Hyposensitive acupoint group |
Primary outcome
Change of the number of angina attacks
Time frame: Change from baseline to week 8
Change of the number of uncomfortable events that met the criteria for angina in study period
3 secondary outcomes
Change of the Canadian Cardiology Society (CCS) Classification of Angina Pectoris
Time frame: Change from baseline to week 8
Change of the Seattle Angina Questionnaire(SAQ) Score
Time frame: Change from baseline to week 8
Change of the use of Therapeutic Nitroglycerin Drugs
Time frame: Change from baseline to week 8
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 30 Mar 2021.
- Derived from this study: PubMed 34765004Huang S, Li L, Liu J, Li X, Shi Q, Li Y, Liu Y, Li M, Ma L, Ning L, Liao X, Ying X, Cai W, Yang F, Wang T, Guo R, Ma W, Chen W, Chen J, Sun X. The Preventive Value of Acupoint Sensitization for Patients with Stable Angina Pectoris: A Randomized, Double-Blind, Positive-Controlled, Multicentre Trial. Evid Based Complement Alternat Med. 2021 Nov 2;2021:7228033. doi: 10.1155/2021/7228033. eCollection 2021.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypersensitive acupoint group and Hyposensitive acupoint group in people with The Clinical Value of Acupoint Sensitization, run by West China Hospital at 1 site in China.
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 4 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 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Change of the number of angina attacks (time frame: Change from baseline to week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03975140, which also lists 1 linked publication.
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 30 Mar 2021.