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Effectiveness of Electro-Press Needle for Menopause-associated Hot Flashes

Primary Purpose

Hot Flashes, Acupuncture Therapy, Perimenopausal Disorder

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Electro Press needle

About this trial

This is an interventional treatment trial for Hot Flashes

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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:
1. The last menstrual period was more than 12 months ago (including 12 months);
2. In the late menopausal transition, and has amenorrhea for more than 60 days;
3. 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.

Sites / Locations

Department of Acupuncture, Guang'anmen HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Electro-Press Needle group

Waiting-list group

Arm Description

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.

Participants in the waiting-list group will receive no intervention for 6 weeks and be followed up till weeks 30.

Outcomes

Primary Outcome Measures

the proportion of patients with a reduction of 50% or more on the mean 24-hour HF score from baseline

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.

Secondary Outcome Measures

The proportion of participants with a reduction of 50% or more on the mean 24-hour HF score from baseline

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.

The proportion of participants with a reduction of 50% or more in the mean 24-hour HF frequency from baseline

The mean 24-hour HF frequency = total number of HF reported/Number of days reported.

The proportion of patients with at least a 50% reduction in the mean 24-hour HF severity from baseline

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.

The changes in the mean 24-h HF score from baseline

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.

The change of Menopause rating scale (MRS) score from baseline

MRS is a common menopause specific subscale, including 11 items from psychological, somatic to urogenital, with 5 as minimal clinically important differences(MCID).

TThe change of Menopause-Specific Quality of Life Questionnaire (MENQOL) score from baseline

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).

The proportion of participants reporting "significantly reduced" or "moderately reduced" based on Global Response Assessment (GRA)

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.

Full Information

NCT ID

NCT04995107

First Posted

August 1, 2021

Last Updated

December 20, 2021

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT04995107

Brief Title

Effectiveness of Electro-Press Needle for Menopause-associated Hot Flashes

Official Title

Effectiveness of Electro-Press Needle for Menopause-associated Hot Flashes: Protocol of a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Recruiting

Study Start Date

December 20, 2021 (Actual)

Primary Completion Date

December 30, 2022 (Anticipated)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hot Flashes, Acupuncture Therapy, Perimenopausal Disorder, Postmenopausal Symptoms

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Masking Description

The statisticians and outcome assessors will be blinded to the allocation.

Allocation

Randomized

Enrollment

122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Electro-Press Needle group

Arm Type

Experimental

Arm Description

Arm Title

Waiting-list group

Arm Type

No Intervention

Arm Description

Participants in the waiting-list group will receive no intervention for 6 weeks and be followed up till weeks 30.

Intervention Type

Device

Intervention Name(s)

Electro Press needle

Other Intervention Name(s)

EPN

Intervention Description

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).

Primary Outcome Measure Information:

Title

the proportion of patients with a reduction of 50% or more on the mean 24-hour HF score from baseline

Description

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.

Time Frame

week 6

Secondary Outcome Measure Information:

Title

The proportion of participants with a reduction of 50% or more on the mean 24-hour HF score from baseline

Description

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.

Time Frame

week 3,18,30

Title

The proportion of participants with a reduction of 50% or more in the mean 24-hour HF frequency from baseline

Description

The mean 24-hour HF frequency = total number of HF reported/Number of days reported.

Time Frame

week 3,6,18,30

Title

The proportion of patients with at least a 50% reduction in the mean 24-hour HF severity from baseline

Description

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.

Time Frame

week 3,6,18,30

Title

The changes in the mean 24-h HF score from baseline

Description

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.

Time Frame

week 3,6,18,30

Title

The change of Menopause rating scale (MRS) score from baseline

Description

MRS is a common menopause specific subscale, including 11 items from psychological, somatic to urogenital, with 5 as minimal clinically important differences(MCID).

Time Frame

week6, 18 and 30

Title

TThe change of Menopause-Specific Quality of Life Questionnaire (MENQOL) score from baseline

Description

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).

Time Frame

week 6, 18 and 30

Title

The proportion of participants reporting "significantly reduced" or "moderately reduced" based on Global Response Assessment (GRA)

Description

Time Frame

week 3 ,6, 18 and 30

Other Pre-specified Outcome Measures:

Title

Participants'acceptability towards EPN

Description

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.

Time Frame

week 1 and 3,at the end of the first and ninth treatments

Title

Participants' belief that EPN might help

Description

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."

Time Frame

Baseline assessmentweek 0

Title

Participants' expectations of improvement to menopausal associated hot flashes

Description

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."

Time Frame

Baseline assessment week 0

Title

Safety assessment

Description

Adverse events and severe adverse events will be recorded in case report form, whether related to interventions or not.

Time Frame

Through study completion

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shudan Yu, master

Phone

15011460149

miaomiao101@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Xin He, bachelor

Phone

15910448046

394564518@qq.com

Facility Information:

Facility Name

Department of Acupuncture, Guang'anmen Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100053

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shudan Yu

Phone

15011460149

miaomiao101@126.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

35147087

Citation

Yu S, He X, Shi H, Chen Y, Liu Z. Effectiveness of electro-press needle for menopause-associated hot flashes: Protocol of a randomized controlled trial. Medicine (Baltimore). 2022 Feb 11;101(6):e28597. doi: 10.1097/MD.0000000000028597.

Results Reference

derived

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Effectiveness of Electro-Press Needle for Menopause-associated Hot Flashes

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