- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04995107
Effectiveness of Electro-Press Needle for Menopause-associated Hot Flashes
December 20, 2021 updated by: Yu Shudan, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Effectiveness of Electro-Press Needle for Menopause-associated Hot Flashes: Protocol of a Randomized Controlled Trial
The investigators plan to conduct the randomized controlled trial to evaluate the effectiveness of electro-press needle (EPN), a novel acupuncture needle combining shallow and gentle insertion with transdermal electrical stimulation, on menopause-associated hot flash in comparison with waiting-list group among women during menopausal transition and postmenopausal periods.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
As the most common type of menopause-associated symptoms, hot flashes affect up to 85% of women aging between 40 and 65 years .
In China, women suffer from hot flushes as long as 4 to 5 years on average, some of whom may bear the symptoms for 12 years.Hormone replacement therapy (HRT) is generally recommended to relieve menopause-associated hot flashes.However, long-term usage of HRT may increase the incidence of endometrial, breast and ovarian cancer, thrombosis and strokes.Results of previous studies indicated that acupuncture might help to relieve the symptoms.There is insufficient evidence supporting its effectiveness for relieving the hot flash symptom.
Study Type
Interventional
Enrollment (Anticipated)
122
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shudan Yu, master
- Phone Number: 15011460149
- Email: miaomiao101@126.com
Study Contact Backup
- Name: Xin He, bachelor
- Phone Number: 15910448046
- Email: 394564518@qq.com
Study Locations
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Beijing
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Beijing, Beijing, China, 100053
- Recruiting
- Department of Acupuncture, Guang'anmen Hospital
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Contact:
- Shudan Yu
- Phone Number: 15011460149
- Email: miaomiao101@126.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Aged between 40-60 years old;
- Scoring 14 points or more in at least one day during the one-week baseline assessment, or having an average of ≥ 7 moderate or severe heating per 24 hours recorded in HF Dairy ;
Fulfilling either condition mentioned below:
- The last menstrual period was more than 12 months ago (including 12 months);
- In the late menopausal transition, and has amenorrhea for more than 60 days;
- FSH≥25IU, and has vasomotor symptoms of HF, sweating, insomnia, migraine, or restlessness, etc.
- Volunteer to participate in this study and sign the informed consent.
Exclusion Criteria:
- Usage of HRT via transdermal administration in the previous one month, or via oral or intrauterine administration in the previous two months; usage of phytoestrogens therapy, transvaginal estrogen administration, or estrogen or progesterone injections in the previous three months;
- Bilateral salpingo-oophorectomy;
- Amenorrhea secondary to premature ovarian failure, ovarian cyst or tumor, thyroid disease, hyperprolactinemia, or Cushing's syndrome, etc.;
- Accepted acupuncture or drugs to treat the symptoms of HF within the previous 3 months;
- Received radiotherapy or chemotherapy before;
- Coagulation dysfunction, or taking warfarin, heparin and other anticoagulant drugs at present;
- Suffering from skin diseases, such as eczema, psoriasis, etc.;
- Severe hepatic and renal insufficiency;
- Uncontrolled hypertension, diabetes or thyroid disease;
- Diabetic neuropathy and mental illness (including depression);
- Being pregnant, breastfeeding or planning to be pregnant during the trial;
- Regular usage of sedatives or anti-anxiety drugs;
- Smoking for more than 5 years (at least twenty cigarettes a day on average) , or with the problem of alcohol abuse;
- Installation of pacemakers;
- Poor compliance.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Electro-Press Needle group
Body acupoints of Yintang (GV29), Dazhui (GV14), Guanyuan (CV4), bilateral Zigong (EX-CA1), and bilateral Sanyinjiao (SP6) and auricular acupoints of Heart (CO15), Chuiqian (LO4) and Shenmen (TF4) will be selected for treatment.
Auricular acupoints on right and left ear will be stimulated alternatively, one side on each time.The treatment will last 40mins for each session, 3 sessions a week (ideally every other day) for a succession of 6 weeks.
|
Body acupoints will be stimulated by the press needles 0.25mm in diameter and 2mm in length and ear acupoints will be stimulated by the press needles 0.25mm in diameter and 0.9mm in length (all from ZhenXing Brand, Hangzhou Yuanli Medical Appliance Factory, China).
After sterilization of the local skin, the needle will be pressed to the acupoints and the tape will be sticked to the skin.
Then, the electric device (φ44×15.8mm
Type ZXHPAMDZB-02C) together with the electrode patch will be sticked to the surface of skin (on top of the sticky tapes of the press needle) in the area of CV4 and bilateral EX-CA1, and bilateral SP6 respectively.
The electric device will be switch to the mode of "dense intermittent wave", and the current intensity will be increased gradually till the muscles around jumps slightly.All the needles on the body acupoints will be removed after each session, while those on the auricular acupoints can be kept for as long as 6 hours (removed before going to bed).
Other Names:
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No Intervention: Waiting-list group
Participants in the waiting-list group will receive no intervention for 6 weeks and be followed up till weeks 30.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the proportion of patients with a reduction of 50% or more on the mean 24-hour HF score from baseline
Time Frame: week 6
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The mean 24-hour HF score = (1 × number of mild HF + 2 × number of moderate HF + 3 × number of severe HF + 4 × number of very severe HF)/Number of days reported.
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week 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of participants with a reduction of 50% or more on the mean 24-hour HF score from baseline
Time Frame: week 3,18,30
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The mean 24-hour HF score = (1 × number of mild HF + 2 × number of moderate HF + 3 × number of severe HF + 4 × number of very severe HF)/Number of days reported.
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week 3,18,30
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The proportion of participants with a reduction of 50% or more in the mean 24-hour HF frequency from baseline
Time Frame: week 3,6,18,30
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The mean 24-hour HF frequency = total number of HF reported/Number of days reported.
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week 3,6,18,30
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The proportion of patients with at least a 50% reduction in the mean 24-hour HF severity from baseline
Time Frame: week 3,6,18,30
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The mean 24-hour HF severity = (1 × number of mild HF + 2 × number of moderate HF + 3 × number of severe HF + 4 × number of very severe HF)/ Number of HF reported.
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week 3,6,18,30
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The changes in the mean 24-h HF score from baseline
Time Frame: week 3,6,18,30
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The mean 24-hour HF score = (1 × number of mild HF + 2 × number of moderate HF + 3 × number of severe HF + 4 × number of very severe HF)/Number of days reported.
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week 3,6,18,30
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The change of Menopause rating scale (MRS) score from baseline
Time Frame: week6, 18 and 30
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MRS is a common menopause specific subscale, including 11 items from psychological, somatic to urogenital, with 5 as minimal clinically important differences(MCID).
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week6, 18 and 30
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TThe change of Menopause-Specific Quality of Life Questionnaire (MENQOL) score from baseline
Time Frame: week 6, 18 and 30
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MENQOL consists of 29 items assessing four domains: VMS, physical symptoms, psychological symptoms, and urogenital/sexual symptoms,with 4 as minimal clinically important differences(MCID).
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week 6, 18 and 30
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The proportion of participants reporting "significantly reduced" or "moderately reduced" based on Global Response Assessment (GRA)
Time Frame: week 3 ,6, 18 and 30
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The response of participants to the treatments are divided into seven grades by GRA: significantly reduced, moderately reduced, slightly reduced, no change, slightly aggravated, moderately aggravated and significantly aggravated.
The proportion of participants reporting "significantly reduced" or "moderately reduced" are recorded as the response rate of the overall efficacy.
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week 3 ,6, 18 and 30
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participants'acceptability towards EPN
Time Frame: week 1 and 3,at the end of the first and ninth treatments
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Use the 3-point method to evaluate, unacceptable (0 points), acceptable (1 points), easy to accept (2 points), patients who cannot accept should be written the reason clearly.Only patients in electric press needle group will score.
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week 1 and 3,at the end of the first and ninth treatments
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Participants' belief that EPN might help
Time Frame: Baseline assessmentweek 0
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Participants in the EPN group will answer the following question before the first intervention: "Do you think acupuncture will be effective for treating the disease?"The participants can answer "Yes", "No", or "Unclear."
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Baseline assessmentweek 0
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Participants' expectations of improvement to menopausal associated hot flashes
Time Frame: Baseline assessment week 0
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Participants in the EPN group will answer the following question before the first intervention: "Do you think acupuncture will be effective for improving menopausal associated HF?" The participants can answer "Yes", "No", or "Unclear."
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Baseline assessment week 0
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Safety assessment
Time Frame: Through study completion
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Adverse events and severe adverse events will be recorded in case report form, whether related to interventions or not.
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Through study completion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2021
Primary Completion (Anticipated)
December 30, 2022
Study Completion (Anticipated)
June 30, 2023
Study Registration Dates
First Submitted
August 1, 2021
First Submitted That Met QC Criteria
August 2, 2021
First Posted (Actual)
August 6, 2021
Study Record Updates
Last Update Posted (Actual)
December 23, 2021
Last Update Submitted That Met QC Criteria
December 20, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-047-KY-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data that underline the results reported in the article after deidentification, excluding the private information of participants.
IPD Sharing Time Frame
Beginning immediately after publication and ending 6 months following article publication
IPD Sharing Access Criteria
Proposals should be directed to miaomiao101@126.com.
To gain access, data requestors wil need to sign a data access agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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