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Evaluation on Biological Characteristics of Acupoints in Premature Ovarian Insufficiency

NCT ID: NCT06145061

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2026-03-30

Brief Summary

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Acupuncture has been widely used in the treatment of Premature Ovarian Insufficiency(POI), but the selection of acupoints is indeterminate and lacks biological basis.In recent years,some studies suggested the "acupoint sensitization",that is,changes such as pain sensitivity and heat sensitivity appear on the acupoints under disease state.The biological characteristics of acupoints can reflect the state of local tissue and might be a potential factor for guiding acupoint selection. This study aims to compare the temperature and pain threshold of acupoints between POI patients and the healthy population.At the meantime,clinical diagnosis of POI is based on clinical symptoms and Follicle Stimulating Hormone (FSH).However,FSH fluctuates so much that prediction accuracy is not high and clinical application is limited.Therefore, given the lack of proper diagnostic accuracy in POI and the concept of "acupoint sensitization",it is necessary to summarize the changes of biological characteristics of related acupoints under physiological and pathological conditions as an auxiliary means to improve the diagnostic rate of POI.

Detailed Description

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The study is a case-control study protocol involving 150 POI patients from three clinical centers and 150 healthy persons in China.The duration of the study is one year, and all patients and healthy people will receive at least 3 infrared thermal imaging examinations of acupoints and pain threshold examinations.The primary outcome is to investigate the difference in the skin temperature and pain threshold of acupoints between POI and healthy persons.In the meanwhile,we will collect FSH, serum estradiol (E2) and some relevant scales,including modified Kupperman Index,Zung's Self-Rating Anxiety Scale(SAS),Zung's Self-Rating Depression Scale(SDS),Traditional Chinese medicine(TCM) constitution scale as second outcomes.

Conditions

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Premature Ovarian Insufficiency

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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POI patients

POI patients:1.meet the diagnostic criteria for POI:POI diagnostic criteria refer to the 2016 European Society for Reproductive Medicine POI guidelines:Age \< 40 years; Oligomenorrhea or amenorrhea for at least 4 months; Two measurements (on day 2-4 of the menstrual cycle, at least 4 weeks apart)Follicle Stimulating Hormone（FSH） \> 25 IU/L and meet the above three requirements.2.18 years old ≤ age \< 40 years old, gender female; 3.They are conscious and able to communicate normally.4.Provide recent transvaginal ultrasound or pelvic color Doppler ultrasound examination report to determine the menstrual cycle.5.Those who understand and are willing to comply with the study protocol and sign the informed consent form.

all patients and healthy people will receive at least 3 infrared thermal imaging examinations of acupoints and pain threshold examinations of acupoints.

Intervention Type DEVICE

Infrared thermal imaging detection scheme of acupoints:Detection equipment NEC R550 infrared thermal imager.Records the corresponding acupoints coordinates,and starts to collect the infrared thermal image.and 6 images will be taken continuously for each detected part.The infrared thermograms were stored and extract the temperature values of the corresponding coordinates of the acupoints.The average temperature values of the acupoints in the six infrared thermograms were calculated as their temperatures.Pain threshold detection scheme of acupoints:The instrument and equipment use the FDX25 hand-held pain threshold test instrument to explore the acupoints.Place the probe of the pain measuring instrument vertically on the pain measuring acupoint, slowly and steadily press downward at a constant speed, and stop pressing immediately when the subject begins to feel pain. At this point, the reading on the display is the subject's pain threshold. All acupoints shall be measured once in total.

healthy subjects

Healthy subjects:1.Healthy subjects who can provide physical examination report within the past 1 year and have routine physical examination by the investigator, and confirm that they have no serious underlying diseases such as reproductive system, urinary system, blood, endocrine system and nervous system;2.Currently no symptoms of oligomenorrhea or amenorrhea;3.18 years ≤ age \< 40 years, female;4.Those who understand and are willing to comply with the study protocol and sign the informed consent form.

all patients and healthy people will receive at least 3 infrared thermal imaging examinations of acupoints and pain threshold examinations of acupoints.

Intervention Type DEVICE

Infrared thermal imaging detection scheme of acupoints:Detection equipment NEC R550 infrared thermal imager.Records the corresponding acupoints coordinates,and starts to collect the infrared thermal image.and 6 images will be taken continuously for each detected part.The infrared thermograms were stored and extract the temperature values of the corresponding coordinates of the acupoints.The average temperature values of the acupoints in the six infrared thermograms were calculated as their temperatures.Pain threshold detection scheme of acupoints:The instrument and equipment use the FDX25 hand-held pain threshold test instrument to explore the acupoints.Place the probe of the pain measuring instrument vertically on the pain measuring acupoint, slowly and steadily press downward at a constant speed, and stop pressing immediately when the subject begins to feel pain. At this point, the reading on the display is the subject's pain threshold. All acupoints shall be measured once in total.

Interventions

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all patients and healthy people will receive at least 3 infrared thermal imaging examinations of acupoints and pain threshold examinations of acupoints.

Infrared thermal imaging detection scheme of acupoints:Detection equipment NEC R550 infrared thermal imager.Records the corresponding acupoints coordinates,and starts to collect the infrared thermal image.and 6 images will be taken continuously for each detected part.The infrared thermograms were stored and extract the temperature values of the corresponding coordinates of the acupoints.The average temperature values of the acupoints in the six infrared thermograms were calculated as their temperatures.Pain threshold detection scheme of acupoints:The instrument and equipment use the FDX25 hand-held pain threshold test instrument to explore the acupoints.Place the probe of the pain measuring instrument vertically on the pain measuring acupoint, slowly and steadily press downward at a constant speed, and stop pressing immediately when the subject begins to feel pain. At this point, the reading on the display is the subject's pain threshold. All acupoints shall be measured once in total.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

2.18 years old ≤ age \< 40 years old, gender female; 3.They are conscious and able to communicate normally. 4.Provide recent transvaginal ultrasound or pelvic color Doppler ultrasound examination report to determine the menstrual cycle.

5.Those who understand and are willing to comply with the study protocol and sign the informed consent form.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xiaomei Shao

OTHER

Sponsor Role lead

Responsible Party

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Xiaomei Shao

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xiaomei Shao, Ph.D

Role: PRINCIPAL_INVESTIGATOR

The Third Affiliated hospital of Zhejiang Chinese Medical University

Locations

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the Third affiliated hospital of Zhejiang Chinese Medical university

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaomei Shao, Ph.D

Role: CONTACT

[email protected]
+8618957130287

Haomin Sun

Role: CONTACT

[email protected]
+8615990031347

Facility Contacts

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Xiaomei Shao, Ph.D

Role: primary

[email protected]
+8618957130287

Other Identifiers

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2023ZX010-POI

Identifier Type: -

Identifier Source: org_study_id