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NCT Number: NCT03121170

Extracorporeal Shock Wave Therapy in the Treatment of Primary Dysmenorrhea

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.

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Key information

Conditions

Dysmenorrhea Primary Dysmenorrhea Menstruation Disturbances Neurologic Manifestations Pain Pain, Menstrual Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jian Yang

Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extracorporeal Shock Wave Therapy

Other

Intervention group is by extracorporeal shock wave therapy.A radial shock wave device (EMS Swiss Dolor, Munich, Germany) was used. Radial shock wave is created ballistically with the pressurized air source accelerating a bullet to strike a metal applicator. The kinetic energy produced is transformed into radially expanding shock waves from the application site into the tissue to be treated. The treatment of area is lower abdomen which has some acupuncture points such as Shenque(CV8) ,Qihai(BL24), Guanyuan(CV4), Zhongji(CV3), Tianshu(ST25), Guilai(ST29) and Zigong(EX-CA1) at the right and left sides of the lower abdomen. All acupuncture points should be placed according to participants' feedback during treatment.

hot compress paste

Other

Hot compress pastes will be sticked on the lower abdomen.

Primary outcomes

  1. Visual analogue scale

    Time frame: At baseline;1st, 2nd, 3rd, 4th, 5th, 6th menstrual cycle after randomization

    Visual analogue scale(VAS) change from baseline in menstrual pain intensity measured by VAS at 6 months.

Secondary outcomes

  1. Self-Rating Anxiety Scale

    Time frame: At baseline;the first menstrual cycle after 3 menstrual cycles treatments;the first menstrual cycle after 3 following-up months

    Self-Rating Anxiety Scale is applied to assess the subject's anxiety and depression level.

  2. prostaglandin F2a metabolite

    Time frame: At baseline(on the 2nd day of menstruation before treatment);on the 2nd day of menstruation cycle after 3 menstrual cycles treatment

    The plasma concentrations of prostaglandin F2α metabolite----Laboratory index

  3. prostaglandin E2 metabolite

    Time frame: At baseline(on the 2nd day of menstruation before treatment);on the 2nd day of menstruation cycle after 3 menstrual cycles treatment

    The plasma concentrations of prostaglandin E2 metabolite----Laboratory index

  4. pictorial blood loss assessment chart

    Time frame: At baseline;the first menstrual cycle after 3 menstrual cycles treatment;the first menstrual cycle after 3 following-up months

    The bleeding amount was measured using chart (PBAC).The chart (PBAC) was completed on menstruation days.

Other outcomes

  1. total pain relief over 4 consecutive hours

    Time frame: 1st, 2nd, 3rd menstruation during treatment

    Total pain relief over 4 consecutive hours (TOPAR4) was completed on the first day of menstrual cycle during treatment.

Sponsors and collaborators

Lead sponsor

Ruirui Xing

Other

Registry information

Official study title

Extracorporeal Shock Wave Therapy in the Treatment of Primary Dysmenorrhea:a Randomized Controlled-placebo Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 20, 2017
Registry last updated
Sep 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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