Comparison Between Hand-acupuncture and Electro-acupuncture Stimulation in the Treatment of Menopause

Not Applicable

Completed

• Conditions: Menopause; Puncture Site Reaction
• Interventions: Behavioral: Hand-acupuncture; Device: Electrico-acupuncture

• Registration Number: NCT02098928
• Lead Sponsor: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Brief Summary

Main objective: to compare the effects of hand-acupuncture and electro-acupuncture stimulation on the baking heat symptoms of menopause Secondary objective: to evaluate the safety and acceptability of hand acupuncture and electroacupuncture stimulation

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-03
• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-27
• Study First Posted: 2014-03-28
• Study Start: 2014-04
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-10-31
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 242

Inclusion Criteria

1. in past of 12 months in, menstrual cycle not rules, menstrual ahead of or wrong Hou ≥ 7 days (menopause transition period early); in past of 12 months in, at least shedding had 2 a menstrual cycle, or amenorrhea over 60 days, but ≤ November (menopause transition period late); last once menstrual to stopped by Hou 3 years within (menopause 3 years within patients)
2. Menopause-related symptoms: baking heat, sweating, insomnia, migraines,irritability, sore vagina, sexual intercourse and so on
3. 40-55 years
4. Baseline scorch score ≥ 6 points
5. without hormone therapy indications for mandatory, such as during menopause, osteoporosis mobility
6. volunteered for this study, and sign the consent form

Exclusion Criteria

1. test within 3 months before the menstrual cycle rules
2. nearly 4 weeks applied estrogen, SSRIs, soy isoflavones, progesterone, vitamin e, or Black Cohosh
3. diameter greater than 4cm fibroid ovarian cyst, ovarian or after hysterectomy
4. disease history of chemotherapy or who are undergoing chemotherapy
5. unexplained vaginal bleeding
6. coagulation disorders or taking anticoagulant drugs such as warfarin, heparin
7. suffered from skin diseases like eczema, psoriasis, etc
8. severe hepatic and renal insufficiency
9. yet controlled high blood pressure, diabetes, or thyroid disease
10. diabetic nerve damage, cancer and mental illnesses (including depression)
11. wishes are in pregnancy or pregnancy or breastfeeding
12. long-term use of sedatives or antidepressants
13. long-term smoking and alcoholism
14. installed pacemaker or artificial joints

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electric-acupuncture group	Electrico-acupuncture	Use Electrico-acupuncture device to therapy. Four acupoints:Tianshu,Zigong,Guanyuan and Sanyinjiao. Every patient are supposed to have 24 times acupuncture treatment. 30 minutes per time.
Hand-acupuncture group	Electrico-acupuncture	Use Hand-acupuncture directly. Four acupoints:Tianshu,Zigong,Guanyuan and Sanyinjiao. Every patient are supposed to have 24 times acupuncture treatment. 30 minutes per time.
Electric-acupuncture group	Hand-acupuncture	Use Electrico-acupuncture device to therapy. Four acupoints:Tianshu,Zigong,Guanyuan and Sanyinjiao. Every patient are supposed to have 24 times acupuncture treatment. 30 minutes per time.
Hand-acupuncture group	Hand-acupuncture	Use Hand-acupuncture directly. Four acupoints:Tianshu,Zigong,Guanyuan and Sanyinjiao. Every patient are supposed to have 24 times acupuncture treatment. 30 minutes per time.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in average scores of 24-hour hot flashes symptoms at 32 weeks	into the group, into the group after the 4th, 8, 20 and 32 weeks.	The average scores of 24 hours hot flashes integration consists of integrating the hot flashes times and hot flashes extent, hot flashes degree of mild, moderate and severe hot flashes three categories. Recorded by diary cards of hot flashes symptoms diary cards.

Secondary Outcome Measures

Name	Time	Method
the serum levels of sex hormones	into the group, into the group after the 8th week; secondary evaluation points: into the group after the 20th week.	Menstruation are required in the first 2-4 days of the menstrual blood test, then if no menstruation, menstrual cycles can wait until next month before testing; menopause, while those in the first eight weeks and 20 weekend testing.
Scores of the Self-Rating Anxiety Scale（SAS）	into the group, into the group after the 4th, 8, 20 and 32 weeks.
Scores of the Self-rating depression scale（SDS）	into the group, into the group after the 4th, 8, 20 and 32 weeks.
Scores of menopause rating scale（MRS）	into the group, into the group after the 4th, 8, 20 and 32 weeks.
Scores of Menopause-Specific Quality of Life Questionnaire （MENQOL）	into the group, into the group after the 4th, 8, 20 and 32 weeks.

Trial Locations

Locations (1)

The first affiliate hospital of Hunan university of chinese traditional medicine; 🇨🇳 Changsha, Hunan, China