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CompletedNCT04741243Updated Mar 11, 2021

Effect of Extracorporeal Shock Therapy for Dysmenorrhea

An interventional study of Extracorporeal Shock wave in Primary Dysmenorrhea, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 25 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-11.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Jun 2019, registered Feb 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
25 Years to 35 Years
Sex
Female
01

Study summary

This study was carried out upon forty women diagnosed as primary dysmenorrhea. They were selected from outpatient clinics of gynecology of Ain Shams University Hospital, Cairo University. Their age ranged from 25-35 years, BMI\<30kg/ m².

Read the detailed description

Patients with primary dysmenorrhea diagnosed by a physician, spondylolisthesis and chronic low back pain were excluded from the study. They were randomly assigned into two equal groups (A\& B). Group (A) consisted of twenty subjects, with an average age 29.2±1.9Yrs, and BMI 27.28±2.1kg/m2 who received Extracorporeal shock waves. Group (B) consisted of twenty patients, with an average age 28.58±2.2Yrs, and BMI 28.92±0.7kg/m2 who received sham technique. A hot pack was used for 15 minutes for both groups (A\&B) before the treatment.

02

Conditions studied

  • Primary Dysmenorrhea
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Criteria:

Inclusion criteria

Inclusion Criteria:

  • forty virgin females.
  • their age ranged between 25 to 35 years old.
  • Body mass index (BMI) \<30kg/ m².

Exclusion criteria

Exclusion Criteria:

  • females with pelvic pathology as endometriosis.
  • females have irregular menstrual cycles.
  • females have secondary dysmenorrhea.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Extracorporeal shock wave therapy

    was used for 15 minutes in a prone position for both groups (A\&B) before the treatment. shock wave were used to heat small areas, and allow for decrease pain, muscle spasm, and provide vasodilatation of the blood vessels supplying the area

    Device: Extracorporeal Shock wave

  • Experimental
    dietary modification

    Dietary modifications are changes made during food preparation, processing, and consumption to increase the bioavailability of micronutrients-and reduce micronutrient deficiencies-in food at the commercial or individual/household level.

    Device: Extracorporeal Shock wave

Interventions

  • DeviceExtracorporeal Shock wave

    Dietary modifications are changes made during food preparation, processing, and consumption to increase the bioavailability of micronutrients-and reduce micronutrient deficiencies-in food at the commercial or individual/household level

    Also known as: dietary modification

06

What researchers measure

Primary outcomes

  1. Visual Analogue Scale

    Visual analogue scale: that was used to determine the pain intensity level. It consists of 10 cm as a horizontal line with one end represented that (0= no pain) and the other end (10= worst pain). The assessment was performed for every woman in both groups (A, B) before and after the treatment program.

    Time frame: three months

Secondary outcomes

  1. analysis of circulating β-endorphin

    assessment of circulating β-endorphin was done before and after the treatment progam

    Time frame: three months

07

Study locations

1 site
  • Ghada Elrefaye
    Giza, Cairo Governorate 12613, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04741243
Lead sponsor
Cairo University
Collaborators
Shaimaa Mohamed Hamed
Responsible party
Ghada Ebrahim El Refaye (assistant professor Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt, Cairo University) — Principal investigator
First posted
Feb 5, 2021
Start date
Jun 24, 2019
Primary completion
Nov 30, 2020
Completion
Dec 1, 2020
Last update
Mar 11, 2021

Study contacts

ghada eb elrefaye, professor
principal investigator · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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