search
Back to results

Extracorporeal Shock Wave Therapy in the Treatment of Primary Dysmenorrhea

Primary Purpose

Dysmenorrhea Primary, Pain, Menstrual

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
extracorporeal shock wave therapy
hot compress paste
Sponsored by
Ruirui Xing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysmenorrhea Primary focused on measuring primary dysmenorrhea, extracorporeal shock wave therapy, traditional Chinese medicine

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Jian Yang

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

ESWT during PD

ESWT before PD

hot compress paste

Arm Description

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.

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.

In hot compress paste group , the women with primary dysmenorrhea stick the hot compress paste on their belly autonomously.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Self-Rating Anxiety Scale
Self-Rating Anxiety Scale is applied to assess the subject's anxiety and depression level.
prostaglandin F2a metabolite
The plasma concentrations of prostaglandin F2α metabolite----Laboratory index
prostaglandin E2 metabolite
The plasma concentrations of prostaglandin E2 metabolite----Laboratory index
pictorial blood loss assessment chart
The bleeding amount was measured using chart (PBAC).The chart (PBAC) was completed on menstruation days.

Full Information

First Posted
March 12, 2017
Last Updated
September 16, 2020
Sponsor
Ruirui Xing
search

1. Study Identification

Unique Protocol Identification Number
NCT03121170
Brief Title
Extracorporeal Shock Wave Therapy in the Treatment of Primary Dysmenorrhea
Official Title
Extracorporeal Shock Wave Therapy in the Treatment of Primary Dysmenorrhea:a Randomized Controlled-placebo Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 4, 2017 (Actual)
Primary Completion Date
May 20, 2018 (Actual)
Study Completion Date
May 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ruirui Xing

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea Primary, Pain, Menstrual
Keywords
primary dysmenorrhea, extracorporeal shock wave therapy, traditional Chinese medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESWT during PD
Arm Type
Experimental
Arm Description
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.
Arm Title
ESWT before PD
Arm Type
Experimental
Arm Description
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.
Arm Title
hot compress paste
Arm Type
Placebo Comparator
Arm Description
In hot compress paste group , the women with primary dysmenorrhea stick the hot compress paste on their belly autonomously.
Intervention Type
Other
Intervention Name(s)
extracorporeal shock wave therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
hot compress paste
Intervention Description
Hot compress pastes will be sticked on the lower abdomen.
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
Visual analogue scale(VAS) change from baseline in menstrual pain intensity measured by VAS at 6 months.
Time Frame
At baseline;1st, 2nd, 3rd, 4th, 5th, 6th menstrual cycle after randomization
Secondary Outcome Measure Information:
Title
Self-Rating Anxiety Scale
Description
Self-Rating Anxiety Scale is applied to assess the subject's anxiety and depression level.
Time Frame
At baseline;the first menstrual cycle after 3 menstrual cycles treatments;the first menstrual cycle after 3 following-up months
Title
prostaglandin F2a metabolite
Description
The plasma concentrations of prostaglandin F2α metabolite----Laboratory index
Time Frame
At baseline(on the 2nd day of menstruation before treatment);on the 2nd day of menstruation cycle after 3 menstrual cycles treatment
Title
prostaglandin E2 metabolite
Description
The plasma concentrations of prostaglandin E2 metabolite----Laboratory index
Time Frame
At baseline(on the 2nd day of menstruation before treatment);on the 2nd day of menstruation cycle after 3 menstrual cycles treatment
Title
pictorial blood loss assessment chart
Description
The bleeding amount was measured using chart (PBAC).The chart (PBAC) was completed on menstruation days.
Time Frame
At baseline;the first menstrual cycle after 3 menstrual cycles treatment;the first menstrual cycle after 3 following-up months
Other Pre-specified Outcome Measures:
Title
total pain relief over 4 consecutive hours
Description
Total pain relief over 4 consecutive hours (TOPAR4) was completed on the first day of menstrual cycle during treatment.
Time Frame
1st, 2nd, 3rd menstruation during treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Wang
Organizational Affiliation
Shanghai Xuhui Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jian Yang
City
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28004000
Citation
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.
Results Reference
background
PubMed Identifier
27904912
Citation
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.
Results Reference
background
PubMed Identifier
23925396
Citation
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.
Results Reference
result
PubMed Identifier
16524531
Citation
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.
Results Reference
result
PubMed Identifier
26564807
Citation
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.
Results Reference
result

Learn more about this trial

Extracorporeal Shock Wave Therapy in the Treatment of Primary Dysmenorrhea

We'll reach out to this number within 24 hrs