The Clinical Value of Acupoint Sensitization Clinical Trial
Official title:
The Preventive Value of Acupoint Sensitization Based on Stable Angina Pectoris
| NCT number | NCT03975140 |
| Other study ID # | 81590955 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 1, 2019 |
| Est. completion date | February 28, 2021 |
| Verified date | March 2021 |
| Source | West China Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 202 |
| Est. completion date | February 28, 2021 |
| Est. primary completion date | February 22, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 35 Years to 80 Years |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| China | The West China Hospital of Sichuan university | Chengdu | Sichuan |
| Lead Sponsor | Collaborator |
|---|---|
| West China Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change of the number of angina attacks | Change of the number of uncomfortable events that met the criteria for angina in study period | Change from baseline to week 8 | |
| Secondary | 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 | Change from baseline to week 8 | |
| Secondary | 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 | Change from baseline to week 8 | |
| Secondary | Change of the use of Therapeutic Nitroglycerin Drugs | Change of the number of times that patients temporarily took nitroglycerin for angina attacks | Change from baseline to week 8 |