Manual Acupuncture for Primary Dysmenorrhea

Primary Dysmenorrhea Clinical Trial

Official title:

Manual Acupuncture vs Sham Acupuncture and Usual Care for the Prevention of Primary Dysmenorrhea: A Multicenter, Randomized, Controlled, Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02783534
• Other study ID #: 201403RCTPD
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2016
• Est. completion date: July 1, 2021

Study information

• Verified date: October 2019
• Source: Huazhong University of Science and Technology
• Contact: Shabei Xu, Doctor
• Phone: 86-13554178768
• Email: xushabei[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary dysmenorrhea (PD) is a common complaint in menstruating women. Although nonsteroidal anti-inflammatory drug is an effective treatment, there are concerns about serious adverse events. Complementary therapies, including acupuncture, are commonly used for PD. Acupuncture has a low risk of adverse effects, while the evidence for the effectiveness of acupuncture in treating PD is inconclusive. Deqi and psychological factors are core concepts in acupuncture theory, but they have been largely neglected in primary dysmenorrhea clinical reports. The objective of this trail is to assess the clinical efficacy of acupuncture in the prevention of PD and investigate what factors will affect the efficacy of acupuncture.The results of this trial will significantly add to the current body of evidence on the role of acupuncture for PD. If found to be effective and safe, acupuncture will be a valuable treatment option in the prevention of PD. In additional, results from this trial will identify what factors will affect the efficacy of acupuncture.

Description:

This is a multicenter, single blind, randomized controlled, three-arm, large-scale clinical trial. We will recruit 300 PD women who meet diagnostic criteria for PD established in 2005 from Canada gynaecology and obstetrics association. Exclusion criteria include illiteracy, breast feeding women, pregnancy women, serious systemic disease, mental patient, and acupuncture experience. Eligible women will be randomly assigned to verum acupuncture group, sham acupuncture group and usual care group. Participants in the verum acupuncture group will receive traditional acupuncture treatment and will be treated with ture needles, While Participants in the sham acupuncture group will be treated with sham acupuncture with non-insertive needles at non-acupuncture points. Acupuncture treatment will start from the 5th or 7th day before the estimated first day of menstrual cycle, and for each cycle, participants will receive one session of treatment each day for 5 consecutive days (a treatment course), totally for 15 sessions and 3 treatment courses. Participants in the usual care group will not receive treatment besides health education as a control group. This trail will be composed of a one-menstrual cycle baseline, three-menstrual cycle treatment (cycle 1 to 3), and three-menstrual cycle follow-up period (cycle 4-6). The primary outcome measure is the change of Cox Menstrual Symptom Scale (CMSS) in a menstrual cycle compared to baseline. Secondary outcome measures include Visual Analogue Scale (VAS), McGill pain questionnaire (SF-MPQ), Pittsburgh sleep quality index (PSQI), and intake of acute medication. Psychological outcome measures are Beck Depression Rating Scale (BDI), Beck Anxiety Inventory (BAI), NEO Five-Factor Inventory (NEO-FFI), the Doctor-Patient Relationship Scale (PDRQ), the Difficult Doctor-Patient Relationship Questionnaire (DDPRQ), and Expectations for interventions assessed by acupuncture expectancy scale (AES). Deqi sensation will be measured by MGH Acupuncture Sensation Scale (MASS).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Diagnosed with PD according to the primary dysmenorrhea established by Canadian Institute of Obstetrics and gynecology in 2005;

2. Aged from 15 to 40 years, have not given birth, and have a history of regular menstrual cycles (28 days±7 days);

3. Pain of intensity is moderate varying from 40 to 80 on the visual analogue scale (VAS), and lasting at least 6 months;

4. Able to complete the baseline dysmenorrhea diary;

5. Able to sign an informed consent

Exclusion Criteria:

1. Secondary dysmenorrhea caused by endometriosis, pelvic inflammation, myomas of uterus or other gynecological problems confirmed by type-B ultrasound exam by gynecologists;

2. Have a history of pelvic or abdominal surgery, or applying oral contraceptives or intrauterine devices;

3. Combined with uncontrolled diagnosed psychiatric disorders such as severe anxiety and depression, or severe systemic diseases affecting the implementation of treatment programs;

4. Taking analgesics such as NSAIDs or having received any other treatment for PD three months prior to enrollment;

5. Women in lactation, pregnant women, or those with plans to get pregnant during any period of the trial;

6. Have experience of acupuncture;

7. Illiterate, or patients unable to read and understand scales.

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Device:
• Verum acupuncture
Participants allocated to VA group will receive traditional acupuncture treatment on the "Guanyuan"(RN 4), bilateral "Sanyinjiao"(SP 6), bilateral "Zigong"(EX-CA1), bilateral "Xuehai"(SP 10). Additional points will be chosen according to TCM syndrome differentiation constitution of patients. If patients with deficient syndrome, bilateral "Zusanli" (ST 36) will be included. If patients with sufficiency syndrome, bilateral "Diji" (SP 8) will be included. The NO.16 special type of acupuncture needle (0.30 x 30 mm) produced by German asia-med company will be applied.The needles will be inserted into the skin of acupuncture points and manipulated manually by using the techniques such as lifting, thrusting, and twirling, until the internal compound sensation known as deqi.
• Sham acupuncture
We use a non-insertive sham control produced by Asia-med Company in Germany—the streitberger placebo-needle. Sham points are described as follows: 1) 5 inch lateral to the seventh thoracic spine; 2) 5 inch lateral to the eighth thoracic spine; 3) 5 inch lateral to the ninth thoracic spine; and 4) 5 inch lateral to the tenth thoracic spine.

Behavioral:
• Usual care
Patients in usual care group will not receive acupuncture treatment but enhance usual care by providing them with detailed information via propaganda booklets or the internet in the form of health education.

Locations

Country	Name	City	State
China	Department of Neurology of Tongji Hospital, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (5)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	Hubei College of Traditional Chinese Medicine, Hubei Hospital of Traditional Chinese Medicine, University Hospital of Huang Jia Lake Campus, Hubei University of Chinese Medicine, Wuhan Hospital of Intergreted Chinese and Western Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Chinese version of Massachusetts General Hospital Acupuncture Sensation Scale		From date of the first session of treatment until date of the fifteenth session of treatment, assessed up to 75 days.
Other	Change in Beck Depression Inventory II (BDI- II) compared to baseline.		At baseline (one menstrual cycle/one month before randomization), at the third month after randomization, and at the sixth month after randomization.
Other	Change in Beck Anxiety Inventory (BAI) compared to baseline.		At baseline (one menstrual cycle/one month before randomization), at the third month after randomization, and at the sixth month after randomization.
Other	60-item NEO Personality Inventory-Short Form (NEO-FFI)		At baseline (one menstrual cycle/one month before randomization) only once.
Other	Patient-Doctor Relationship Questionnaire (PDRQ-9).		At baseline (one menstrual cycle/one month before randomization), at the third month after randomization, and at the sixth month after randomization.
Other	Acupuncture expectancy scale		Before the first session of treatment, at the end of the third session of treatment (on day 3), and at the end of the fifteenth session of treatment (up to 75 days).
Other	Chinese medicine constitution questionnaire		At baseline (one menstrual cycle/one month before randomization), at the third month after randomization, and at the sixth month after randomization.
Other	Difficult Doctor-Patient Relationship Questionnaire (DDPRQ-10).		At baseline (one menstrual cycle/one month before randomization), at the third month after randomization, and at the sixth month after randomization.
Primary	Change of Cox Menstrual Symptom Scale (CMSS) in a menstrual cycle compared to baseline.		At baseline (one menstrual cycle/one month before randomization), the first,second, third, fourth, fifth, and sixth month after randomization.
Secondary	Change of Visual Analogue Scale (VAS) in a menstrual cycle compared to baseline.		At baseline (one menstrual cycle/one month before randomization), the first,second, third, fourth, fifth, and sixth month after randomization.
Secondary	Change of McGill pain questionnaire (SF-MPQ) in a menstrual cycle compared to baseline.		At baseline (one menstrual cycle/one month before randomization), the first,second, third, fourth, fifth, and sixth month after randomization.
Secondary	Change of Pittsburgh sleep quality index (PSQI) in a menstrual cycle compared to baseline.		At baseline (one menstrual cycle/one month before randomization), the first,second, third, fourth, fifth, and sixth month after randomization.
Secondary	Change of the dose of intake of acute medication in a menstrual cycle compared to baseline.		At baseline (one menstrual cycle/one month before randomization), the first,second, third, fourth, fifth, and sixth month after randomization.