Extracorporeal Shock Wave Therapy in the Treatment of Primary Dysmenorrhea

NCT03121170 | Completed

• 1 other identifier: XHYY2016-05
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysmenorrhea Primary; Pain, Menstrual

Keywords

primary dysmenorrhea; extracorporeal shock wave therapy; traditional Chinese medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Self-Rating Anxiety Scale

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

• prostaglandin F2a metabolite

  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

  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

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

Other Outcomes (1)

• total pain relief over 4 consecutive hours

  1st, 2nd, 3rd menstruation during treatment

Study Arms (3)

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.

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.

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.

Other: hot compress paste

Interventions

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.

ESWT before PD; ESWT during PD

hot compress paste OTHER

Hot compress pastes will be sticked on the lower abdomen.

hot compress paste

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruirui Xing: lead

Study Sites (1)

Jian Yang

Shanghai, China

Location

Related Publications (5)

• 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.

  PMID: 28004000 BACKGROUND

• 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.

  PMID: 27904912 BACKGROUND

• 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.

  PMID: 23925396 RESULT

• 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.

  PMID: 16524531 RESULT

• 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.

  PMID: 26564807 RESULT

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Yan Wang

  Shanghai Xuhui Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Master

Study Record Dates

• First Submitted: March 12, 2017
• First Posted: April 20, 2017
• Study Start: February 4, 2017
• Primary Completion: May 20, 2018
• Study Completion: May 30, 2019
• Last Updated: September 21, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)