Clinical trial NCT03121170: Extracorporeal Shock Wave Therapy in the Treatment of Primary Dysmenorrhea
Official title: Extracorporeal Shock Wave Therapy in the Treatment of Primary Dysmenorrhea:a Randomized Controlled-placebo Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysmenorrhea Primary
Pain, Menstrual
Keywords: primary dysmenorrhea
extracorporeal shock wave therapy
traditional Chinese medicine
Lead sponsor: Xuhui Central Hospital, Shanghai
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual analogue scale
timeFrame: At baseline;1st, 2nd, 3rd, 4th, 5th, 6th menstrual cycle after randomization
Secondary outcomes:
measure: Self-Rating Anxiety Scale
timeFrame: At baseline;the first menstrual cycle after 3 menstrual cycles treatments;the first menstrual cycle after 3 following-up months
measure: prostaglandin F2a metabolite
timeFrame: At baseline(on the 2nd day of menstruation before treatment);on the 2nd day of menstruation cycle after 3 menstrual cycles treatment
measure: prostaglandin E2 metabolite
timeFrame: At baseline(on the 2nd day of menstruation before treatment);on the 2nd day of menstruation cycle after 3 menstrual cycles treatment
measure: pictorial blood loss assessment chart
timeFrame: At baseline;the first menstrual cycle after 3 menstrual cycles treatment;the first menstrual cycle after 3 following-up months
Other outcomes:
measure: total pain relief over 4 consecutive hours
timeFrame: 1st, 2nd, 3rd menstruation during treatment
Locations:
city: Shanghai
country: China
facility: Jian Yang
Study officials:
affiliation: Shanghai Xuhui Central Hospital
name: Yan Wang
role: PRINCIPAL_INVESTIGATOR
References:
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