Manual Acupuncture for Primary Dysmenorrhea

NCT02783534 | Unknown DMC

• 1 other identifier: 201403RCTPD
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Dysmenorrhea

Keywords

Acupuncture; Primary Dysmenorrhea; Randomized Controlled Trial; Placebo Effect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Other Outcomes (8)

• 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.

• 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.

• 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.

Study Arms (3)

Verum acupuncture

EXPERIMENTAL

Participants will receive verum acupuncture plus usual care. Participants will receive acupuncture treatment 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, totally be treated with 15 sessions.Verum needles will be inserted into the skin and manipulated manually until deqi occurs. The needles are retained for 30 min in each session. During the treatment, the acupuncturist inquires the patient about deqi sensations and manipulates the needles to maintain the intensity of deqi. Participants will receive the same usual care as those in the usual care group.

Device: Verum acupuncture; Behavioral: Usual care

Sham acupuncture

SHAM COMPARATOR

Participants will receive sham acupuncture plus usual care. The Streitberger placebo needle will be placed at non-acupuncture points which are distant from the meridian parts and not located on the same neuromuscular segments as the prescribed points used in the VA group, so as to minimize any therapeutic and segmental effects. The same acupuncture schedule as that in the verum acupuncture group will be applied. The needles are retained for 30 min in each session. During the treatment, the acupuncturist inquires the patient about deqi sensations and pretends to manipulate the needles but deqi is not sought.Participants will receive the same usual care as those in the usual care group.

Device: Sham acupuncture; Behavioral: Usual care

Usual care

PLACEBO COMPARATOR

Participants will not receive acupuncture treatment besides health education as a control group.

Behavioral: Usual care

Interventions

Verum acupuncture DEVICE

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.

Verum acupuncture

Sham acupuncture DEVICE

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.

Sham acupuncture

Usual care BEHAVIORAL

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.

Sham acupuncture; Usual care; Verum acupuncture

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosed with PD according to the primary dysmenorrhea established by Canadian Institute of Obstetrics and gynecology in 2005;
• Aged from 15 to 40 years, have not given birth, and have a history of regular menstrual cycles (28 days±7 days);
• Pain of intensity is moderate varying from 40 to 80 on the visual analogue scale (VAS), and lasting at least 6 months;
• Able to complete the baseline dysmenorrhea diary;
• Able to sign an informed consent

You may not qualify if:

• Secondary dysmenorrhea caused by endometriosis, pelvic inflammation, myomas of uterus or other gynecological problems confirmed by type-B ultrasound exam by gynecologists;
• Have a history of pelvic or abdominal surgery, or applying oral contraceptives or intrauterine devices;
• Combined with uncontrolled diagnosed psychiatric disorders such as severe anxiety and depression, or severe systemic diseases affecting the implementation of treatment programs;
• Taking analgesics such as NSAIDs or having received any other treatment for PD three months prior to enrollment;
• Women in lactation, pregnant women, or those with plans to get pregnant during any period of the trial;
• Have experience of acupuncture;
• Illiterate, or patients unable to read and understand scales.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• Hubei College of Traditional Chinese Medicine: collaborator
• Hubei Hospital of Traditional Chinese Medicine: collaborator
• Wuhan Integrated Traditional Chinese and Western Medicine Hospital: collaborator
• University Hospital of Huang Jia Lake Campus, Hubei University of Chinese Medicine: collaborator

Study Sites (1)

Department of Neurology of Tongji Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Related Publications (1)

• Yu L, Liu S, Zheng C, Liu W, Wang H, Liang F, Lu W, Xu S, Wang W. Manual acupuncture versus sham acupuncture and usual care for the prevention of primary dysmenorrhea (PD): study protocol for a randomized controlled trial. Trials. 2020 Sep 29;21(1):818. doi: 10.1186/s13063-020-04720-5.

  PMID: 32993752 DERIVED

Study Officials

• Wei Wang, Doctor

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shabei Xu, Doctor

CONTACT

86-13554178768; xushabei@126.com

Lingling Yu, Doctor

CONTACT

86-13545862185; 527679774@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: May 26, 2016
• Study Start: August 2, 2016
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: October 25, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)