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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Sponsor:
Collaborator:
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Information provided by (Responsible Party):
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT02098928
First received: March 5, 2014
Last updated: April 11, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Menopause
Puncture Site Reaction
Behavioral: Hand-acupuncture
Device: Electrico-acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Multicenter Randomized Controlled Trial on Comparison of Efficacy Between Hand Acupuncture and Electro-acupuncture in Treatment of Menopausal Hot Flashes Symptoms

Resource links provided by NLM:


Further study details as provided by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Change from Baseline in average scores of 24-hour hot flashes symptoms at 32 weeks [ Time Frame: into the group, into the group after the 4th, 8, 20 and 32 weeks. ] [ Designated as safety issue: No ]
    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:
  • Scores of menopause rating scale(MRS) [ Time Frame: into the group, into the group after the 4th, 8, 20 and 32 weeks. ] [ Designated as safety issue: No ]
  • Scores of Menopause-Specific Quality of Life Questionnaire (MENQOL) [ Time Frame: into the group, into the group after the 4th, 8, 20 and 32 weeks. ] [ Designated as safety issue: No ]
  • Scores of the Self-Rating Anxiety Scale(SAS) [ Time Frame: into the group, into the group after the 4th, 8, 20 and 32 weeks. ] [ Designated as safety issue: No ]
  • Scores of the Self-rating depression scale(SDS) [ Time Frame: into the group, into the group after the 4th, 8, 20 and 32 weeks. ] [ Designated as safety issue: No ]
  • the serum levels of sex hormones [ Time Frame: into the group, into the group after the 8th week; secondary evaluation points: into the group after the 20th week. ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • safety evaluation of acupuncture [ Time Frame: immediate records ] [ Designated as safety issue: Yes ]
    Content including broken needle, and left needle, and during, and acupuncture pain and the VAS scoring, and difficult endured of acupuncture pain (VAS ≥ 8 points, 10 points system), and needle Hou pain and the scoring, and continued time over 2 hours of more dramatic of needle Hou pain (VAS ≥ 4 points, 10 points system), and local hematoma, and infection or abscess; acupuncture Hou other does not apply sense (refers to acupuncture Hou appeared of fatigue, and palpitations, and dizzy, and headache, and insomnia, symptoms of VAS scoring of average degree and the average continued time; other is not foreseen of bad event. Form sheet for specific, when the diagnosis and treatment of patients at a time, asks if there are adverse events and reactions, if any, immediate records.

  • evaluation of discomfort when acupuncturing [ Time Frame: 1TH and 12th within 5 minutes after the end of acupuncture treatment, take these two averages. Where a VAS value is missing, a VAS for the result. ] [ Designated as safety issue: Yes ]
    evaluation of VAS maximum discomfort occurs during treatment.

  • subjects acceptance evaluation [ Time Frame: 1TH and 12th at the end of treatment with acupuncture and moxibustion, and taking the average. ] [ Designated as safety issue: Yes ]
    an evaluation using the 0-4 system, that is divided into unacceptable (0 points), is more difficult to accept (1), moderate access (2 points), the more acceptable (3 points), very easy to take (4 points), causes unacceptable to write out.

  • health economics indexes [ Time Frame: into the group after 8th during recording. ] [ Designated as safety issue: No ]
    Includes direct medical costs (check fees, fees and other costs of acupuncture and moxibustion) and hidden costs (such as round trip transportation, lost)

  • research evaluation [ Time Frame: to 32nd after into the Group during recording ] [ Designated as safety issue: No ]
    Compliance, rejection and expulsion rates


Estimated Enrollment: 242
Study Start Date: April 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hand-acupuncture group
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.
Behavioral: 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.
Other Name: Use Hua Tuo brand disposable acupuncture needles
Device: 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.
Other Name: SDZ electro-acupuncture device
Placebo Comparator: Electric-acupuncture group
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.
Behavioral: 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.
Other Name: Use Hua Tuo brand disposable acupuncture needles
Device: 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.
Other Name: SDZ electro-acupuncture device

  Eligibility

Ages Eligible for Study:   40 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02098928

Contacts
Contact: zhong feng, doctor 8618711009633 498867441@qq.com

Locations
China, Hunan
The first affiliate hospital of Hunan university of chinese traditional medicine Recruiting
Changsha, Hunan, China, 410007
Contact: Zhong Feng, doctor    +8618711009633    ahtcmzhong@163.com   
Principal Investigator: Cao Yue, doctor         
Sponsors and Collaborators
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Investigators
Study Chair: zhang wei, Professor The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
  More Information

No publications provided

Responsible Party: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02098928     History of Changes
Other Study ID Numbers: 2012BAI24B01
Study First Received: March 5, 2014
Last Updated: April 11, 2014
Health Authority: China: Ethics Committee
China: Food and Drug Administration
China: State Administration of Traditional Chinese Medicine of the People's Republic of China

Keywords provided by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine:
Acupuncture
Electro acupuncture
Menopause

ClinicalTrials.gov processed this record on September 22, 2014