Manual Acupuncture for Primary Dysmenorrhea

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

Interventions

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.

DEVICE

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.

Sponsors & Collaborators

• Hubei College of Traditional Chinese Medicine

  collaborator OTHER

• Hubei Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Wuhan Integrated Traditional Chinese and Western Medicine Hospital

  collaborator OTHER

• University Hospital of Huang Jia Lake Campus, Hubei University of Chinese Medicine

  collaborator UNKNOWN

• Huazhong University of Science and Technology

  lead OTHER

Principal Investigators

• Wei Wang, Doctor · Tongji Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-02

Primary Completion

2021-07-01

Completion

2021-07-01

Countries

• China

Study Locations