Extracorporeal Shock Wave Therapy in the Treatment of Primary Dysmenorrhea

Ruirui Xing

Status: Completed

Conditions: Pain, Menstrual; Dysmenorrhea Primary

Treatments: Other: hot compress paste; Other: extracorporeal shock wave therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03121170

XHYY2016-05

Details and patient eligibility

About

Primary dysmenorrhea (PD) is a common female disease during menstruating. Although nonsteroidal anti-inflammatory drug is an effective treatment, there are concerns about side effects. Alternative therapies, including acupuncture and moxibustion, are commonly used for PD. Nevertheless, traditional Chinese medicine takes longer period than Western medicine to release PD. Extracorporeal shock wave therapy (ESWT) originally for the treatment of musculoskeletal diseases has characteristics of fast curative effect and no wound. Currently there is no report about clinical use of ESWT for the treatment of PD. Our study is to determine whether ESWT is effective in the treatment of PD based on meridian theory of traditional Chinese medicine. The investigators hypothesis that ESWT during PD is more effective than ESWT before PD or abdominal hot paste during PD without ESWT.

Full description

This randomized sham-controlled trial is to determine whether ESWT is effective in the treatment of PD. Patients are randomly divided into 3 groups: 1. ESWT treatment during PD (n=15）; 2. ESWT treatment before PD（n=15）; 3. abdominal hot paste during PD without ESWT（n=15）.

Exclusion criteria: secondary PD, concomitant chronic disease (epilepsy, gastrointestinal, cardiovascular and renal diseases), taken oral contraceptives or vitamin/ mineral supplements in the past 3 months, taking part in other clinical trials.

Medical history will be recorded before the treatment. A questionnaire will be filled by the participant. Blood samples will be collected before and after the treatment. Participants will be followed up closely by a professional nurse. Participants in group 1 will receive ESWT treatment on day1 and day 3 of each menstrual cycle. Participants in group 2 will receive twice ESWT treatment one week before the estimated first day of the menstrual cycle. Participants in group 3 will receive hot compress paste on their belly 2 inches under the navel whenever they feel painful during the menstrual cycle. Patients with PD are treated for three menstrual cycles and followed by three menstrual cycles. Evaluation time point will be one-menstrual cycle baseline, third-menstrual cycle treatment, and third-menstrual cycle follow-up period. The investigators will inform participants to keep warm, avoid cold drink and have a healthy lifestyle via telephone communication each week during the trial.

The plasma concentrations of prostaglandin F2a metabolite, PGE2, visual analogue scale (VAS), and pictorial blood loss assessment chart (PBLA), total pain relief over 4 consecutive hours (TOPAR4), Self-Rating Anxiety Scale (SAS) and other questionnaires about menstrual pain will be recorded and evaluated before and after treatment.

Enrollment: 44 patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosed with PD ;
• women aged from 18 to 30 years;
• painful and relatively regular menstruation (duration of menstrual cycle 21 to 35 days) in recent three cycles with maximum pain intensity over 40 mm according to 10 cm visual analog scale (VAS), with primary dysmenorrhea pain features;
• willing to or already taking part in clinical trials;
• able to sign an informed consent

Exclusion criteria

• known lactose intolerance or chronic disease (including epilepsy, gastrointestinal, cardio-vascular or renal diseases);
• taking oral contraceptives, or regularly taking mineral or vitamin supplements in the past 3 months;
• women in pregnant women, or those with plans to get pregnant during any period of the trial;
• have experience of acupuncture

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 3 patient groups, including a placebo group

ESWT during PD

Experimental group

Description:

For women with primary dysmenorrhea, they have new devise Extracorporeal Shock Wave Therapy to treat. The dose is 15 hertz, 1.8-2.2bar and total 5000 frequencies approximately. The time is menstrual cycle first one and third day, and the therapy divide into two times.

Treatment:

Other: extracorporeal shock wave therapy

ESWT before PD

Experimental group

Description:

For women with primary dysmenorrhea, they have new devise Extracorporeal Shock Wave Therapy to treat. The dose is 15 hertz, 1.8-2.2 bar and total 5000 frequencies approximately. The time start from the 5th and 7th day before the estimated first day of menstrual cycle and all therapy time consuming need 15 minutes.

Treatment:

Other: extracorporeal shock wave therapy

hot compress paste

Placebo Comparator group

Description:

In hot compress paste group , the women with primary dysmenorrhea stick the hot compress paste on their belly autonomously.

Treatment:

Other: hot compress paste