Dysmenorrhea PrimaryNCT03121170
Extracorporeal Shock Wave Therapy in the Treatment of Primary Dysmenorrhea
A study testing extracorporeal shock wave therapy and hot compress paste in people with Dysmenorrhea Primary and Pain, Menstrual, run by Ruirui Xing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Dysmenorrhea Primary, Pain, Menstrual
- What is being tested?
- extracorporeal shock wave therapy and hot compress paste
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 4 Feb 2017to 30 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dysmenorrhea Primary, Pain, Menstrual
- Being tested
- extracorporeal shock wave therapy, hot compress paste
- Keywords
- primary dysmenorrhea, extracorporeal shock wave therapy, traditional Chinese medicine
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extracorporeal shock wave therapyOther
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 pasteOther
Hot compress pastes will be sticked on the lower abdomen.
| Study group | Role | What they receive |
|---|---|---|
| ESWT during PD | Experimental | 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. Receives: Other: extracorporeal shock wave therapy |
| ESWT before PD | Experimental | 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. Receives: Other: extracorporeal shock wave therapy |
| hot compress paste | Placebo comparator | In hot compress paste group , the women with primary dysmenorrhea stick the hot compress paste on their belly autonomously. Receives: Other: hot compress paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
Visual analogue scale(VAS) change from baseline in menstrual pain intensity measured by VAS at 6 months.
Measured: At baseline;1st, 2nd, 3rd, 4th, 5th, 6th menstrual cycle after randomization
Secondary outcomes (4)
Self-Rating Anxiety Scale
Self-Rating Anxiety Scale is applied to assess the subject's anxiety and depression level.
Measured: At baseline;the first menstrual cycle after 3 menstrual cycles treatments;the first menstrual cycle after 3 following-up months
prostaglandin F2a metabolite
The plasma concentrations of prostaglandin F2α metabolite----Laboratory index
Measured: 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
The plasma concentrations of prostaglandin E2 metabolite----Laboratory index
Measured: 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
The bleeding amount was measured using chart (PBAC).The chart (PBAC) was completed on menstruation days.
Measured: At baseline;the first menstrual cycle after 3 menstrual cycles treatment;the first menstrual cycle after 3 following-up months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start4 Feb 2017
- Primary completion20 May 2018
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dysmenorrhea PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruirui Xing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ruirui Xing, Xuhui Central Hospital, Shanghai
- Investigators
- Yan Wang, Principal investigator, Xuhui Central Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121170
- Sponsor's protocol ID
- XHYY2016-05
- Status last verified
- Sep 2020
- First submitted
- 12 Mar 2017
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheng Y, Zhang J, Cai Y. Utility of Ultrasonography in Assessing the Effectiveness of Extracorporeal Shock Wave Therapy in Insertional Achilles Tendinopathy. Biomed Res Int. 2016;2016:2580969. doi: 10.1155/2016/2580969. Epub 2016 Nov 28.
PubMed 28004000Imamura M, Alamino S, Hsing WT, Alfieri FM, Schmitz C, Battistella LR. Radial extracorporeal shock wave therapy for disabling pain due to severe primary knee osteoarthritis. J Rehabil Med. 2017 Jan 19;49(1):54-62. doi: 10.2340/16501977-2148.
PubMed 27904912Dmitrovic R, Kunselman AR, Legro RS. Sildenafil citrate in the treatment of pain in primary dysmenorrhea: a randomized controlled trial. Hum Reprod. 2013 Nov;28(11):2958-65. doi: 10.1093/humrep/det324. Epub 2013 Aug 6.
PubMed 23925396Lefebvre G, Pinsonneault O, Antao V, Black A, Burnett M, Feldman K, Lea R, Robert M; SOGC. Primary dysmenorrhea consensus guideline. J Obstet Gynaecol Can. 2005 Dec;27(12):1117-46. doi: 10.1016/s1701-2163(16)30395-4. English, French.
PubMed 16524531Tomas-Rodriguez MI, Palazon-Bru A, Martinez-St John DRJ, Toledo-Marhuenda JV, Asensio-Garcia MDR, Gil-Guillen VF. Effectiveness of medical taping concept in primary dysmenorrhoea: a two-armed randomized trial. Sci Rep. 2015 Nov 13;5:16671. doi: 10.1038/srep16671.
PubMed 26564807
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Shock Wave Therapy in the Treatment of Primary Dysmenorrhea:a Randomized Controlled-placebo Trial
- ClinicalTrials.gov ID
- NCT03121170
- Acronym / sponsor ID
- XHYY2016-05
- Conditions
- Dysmenorrhea Primary, Pain, Menstrual
- Keywords
- primary dysmenorrhea, extracorporeal shock wave therapy, traditional Chinese medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ruirui XingUniversity, hospital or other
- Study start
- 4 Feb 2017 (actual)
- Primary completion
- 20 May 2018 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 20 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ESWT during PD | Experimental | Other: extracorporeal shock wave therapyFor 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. |
| ESWT before PD | Experimental | Other: extracorporeal shock wave therapyFor 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. |
| hot compress paste | Placebo comparator | Other: hot compress pasteIn hot compress paste group , the women with primary dysmenorrhea stick the hot compress paste on their belly autonomously. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extracorporeal shock wave therapyIntervention 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. | Other | ESWT before PD, ESWT during PD |
| hot compress pasteHot compress pastes will be sticked on the lower abdomen. | Other | hot compress paste |
Primary outcome
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.
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Background: PubMed 28004000Cheng Y, Zhang J, Cai Y. Utility of Ultrasonography in Assessing the Effectiveness of Extracorporeal Shock Wave Therapy in Insertional Achilles Tendinopathy. Biomed Res Int. 2016;2016:2580969. doi: 10.1155/2016/2580969. Epub 2016 Nov 28.
- Background: PubMed 27904912Imamura M, Alamino S, Hsing WT, Alfieri FM, Schmitz C, Battistella LR. Radial extracorporeal shock wave therapy for disabling pain due to severe primary knee osteoarthritis. J Rehabil Med. 2017 Jan 19;49(1):54-62. doi: 10.2340/16501977-2148.
- Results publication: PubMed 23925396Dmitrovic R, Kunselman AR, Legro RS. Sildenafil citrate in the treatment of pain in primary dysmenorrhea: a randomized controlled trial. Hum Reprod. 2013 Nov;28(11):2958-65. doi: 10.1093/humrep/det324. Epub 2013 Aug 6.
- Results publication: PubMed 16524531Lefebvre G, Pinsonneault O, Antao V, Black A, Burnett M, Feldman K, Lea R, Robert M; SOGC. Primary dysmenorrhea consensus guideline. J Obstet Gynaecol Can. 2005 Dec;27(12):1117-46. doi: 10.1016/s1701-2163(16)30395-4. English, French.
- Results publication: PubMed 26564807Tomas-Rodriguez MI, Palazon-Bru A, Martinez-St John DRJ, Toledo-Marhuenda JV, Asensio-Garcia MDR, Gil-Guillen VF. Effectiveness of medical taping concept in primary dysmenorrhoea: a two-armed randomized trial. Sci Rep. 2015 Nov 13;5:16671. doi: 10.1038/srep16671.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Wang principal investigator
Xuhui Central Hospital, Shanghai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extracorporeal shock wave therapy and hot compress paste in people with Dysmenorrhea Primary and Pain, Menstrual, run by Ruirui Xing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (time frame: At baseline;1st, 2nd, 3rd, 4th, 5th, 6th menstrual cycle after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03121170, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2020; AzTrials last refreshed its copy on 8 Nov 2026.