Extracorporeal Shock Wave Therapy in the Treatment of Primary Dysmenorrhea

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: Completed
• Conditions: Pain, Menstrual; Dysmenorrhea Primary
• Intervention / Treatment: Other: extracorporeal shock wave therapy; Other: hot compress paste

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: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Jian Yang

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Visual analogue scale	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

Outcome Measure	Measure Description	Time Frame
Self-Rating Anxiety Scale	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	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	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	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

Outcome Measure	Measure Description	Time Frame
total pain relief over 4 consecutive hours	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

• Sponsor: Ruirui Xing
• Investigators: Principal Investigator: Yan Wang, Shanghai Xuhui Central Hospital

Publications and helpful links

General 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.
• Imamura 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.
• Dmitrovic 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.
• Lefebvre 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.
• Tomas-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.

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2017
• Primary Completion (Actual): May 20, 2018
• Study Completion (Actual): May 30, 2019

Study Registration Dates

• First Submitted: March 12, 2017
• First Submitted That Met QC Criteria: April 13, 2017
• First Posted (Actual): April 20, 2017

Study Record Updates

• Last Update Posted (Actual): September 21, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: extracorporeal shock wave therapy; primary dysmenorrhea; traditional Chinese medicine
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID 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