Extracorporeal Shock Wave Therapy in the Treatment of Primary Dysmenorrhea

September 16, 2020 updated by: Ruirui Xing

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Jian Yang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ESWT during PD
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.
Other: extracorporeal shock wave therapy
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.
Experimental: ESWT before PD
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.
Other: extracorporeal shock wave therapy
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.
Placebo Comparator: hot compress paste
In hot compress paste group , the women with primary dysmenorrhea stick the hot compress paste on their belly autonomously.
Other: hot compress paste
Hot compress pastes will be sticked on the lower abdomen.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At baseline;1st, 2nd, 3rd, 4th, 5th, 6th menstrual cycle after randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At baseline;the first menstrual cycle after 3 menstrual cycles treatments;the first menstrual cycle after 3 following-up months
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
At baseline(on the 2nd day of menstruation before treatment);on the 2nd day of menstruation cycle after 3 menstrual cycles treatment
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
At baseline(on the 2nd day of menstruation before treatment);on the 2nd day of menstruation cycle after 3 menstrual cycles treatment
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.
At baseline;the first menstrual cycle after 3 menstrual cycles treatment;the first menstrual cycle after 3 following-up months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
1st, 2nd, 3rd menstruation during treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ruirui Xing

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yan Wang, Shanghai Xuhui Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 4, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XHYY2016-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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