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出境医 / 临床实验 / The Preventive Value of Acupoint Sensitization Based on Stable Angina Pectoris

The Preventive Value of Acupoint Sensitization Based on Stable Angina Pectoris

Study Description
Brief 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.

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.


Condition or disease Intervention/treatment Phase
The Clinical Value of Acupoint Sensitization Procedure: Hypersensitive acupoint group Procedure: Hyposensitive acupoint group Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: The Preventive Value of Acupoint Sensitization Based on Stable Angina Pectoris
Actual Study Start Date : June 1, 2019
Actual Primary Completion Date : February 22, 2021
Actual Study Completion Date : February 28, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Hypersensitive acupoint group Procedure: Hypersensitive acupoint group
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.
Active Comparator: Hyposensitive acupoint group Procedure: Hyposensitive acupoint group
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.
Outcome Measures
Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change of the Canadian Cardiology Society (CCS) Classification of Angina Pectoris [ Time Frame: Change from baseline to week 8 ]
    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

  2. Change of the Seattle Angina Questionnaire(SAQ) Score [ Time Frame: Change from baseline to week 8 ]
    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

  3. Change of the use of Therapeutic Nitroglycerin Drugs [ Time Frame: Change from baseline to week 8 ]
    Change of the number of times that patients temporarily took nitroglycerin for angina attacks


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Locations
Layout table for location information
China, Sichuan
The West China Hospital of Sichuan university
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
West China Hospital
Tracking Information
First Submitted Date  ICMJE May 24, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date March 30, 2021
Actual Study Start Date  ICMJE June 1, 2019
Actual Primary Completion Date February 22, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • Change of the Canadian Cardiology Society (CCS) Classification of Angina Pectoris [ Time Frame: Change from baseline to week 8 ]
    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 of the Seattle Angina Questionnaire(SAQ) Score [ Time Frame: Change from baseline to week 8 ]
    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 of the use of Therapeutic Nitroglycerin Drugs [ Time Frame: Change from baseline to week 8 ]
    Change of the number of times that patients temporarily took nitroglycerin for angina attacks
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Preventive Value of Acupoint Sensitization Based on Stable Angina Pectoris
Official Title  ICMJE The Preventive Value of Acupoint Sensitization Based on Stable Angina Pectoris
Brief 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.

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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE The Clinical Value of Acupoint Sensitization
Intervention  ICMJE
  • Procedure: Hypersensitive acupoint group
    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.
  • Procedure: Hyposensitive acupoint group
    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 Arms  ICMJE
  • Experimental: Hypersensitive acupoint group
    Intervention: Procedure: Hypersensitive acupoint group
  • Active Comparator: Hyposensitive acupoint group
    Intervention: Procedure: Hyposensitive acupoint group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2021) 		202
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2019) 		160
Actual Study Completion Date  ICMJE February 28, 2021
Actual Primary Completion Date February 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03975140
Other Study ID Numbers  ICMJE 81590955
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sun Xin, West China Hospital
Study Sponsor  ICMJE West China Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account West China Hospital
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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