Effect of Extracorporeal Shock Therapy for Dysmenorrhea

Primary Dysmenorrhea Clinical Trial

Official title:

Effect of Extracorporeal Shock Therapy for Dysmenorrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04741243
• Other study ID #: Cairo Un 99
• Status: Completed
• Phase: N/A
• Start date: June 24, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: March 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

Criteria:

Inclusion Criteria:

• forty virgin females.

• their age ranged between 25 to 35 years old.

• Body mass index (BMI) <30kg/ m².

Exclusion Criteria:

• females with pelvic pathology as endometriosis.

• females have irregular menstrual cycles.

• females have secondary dysmenorrhea.

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Device:
• Extracorporeal 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

Locations

Country	Name	City	State
Egypt	Ghada Elrefaye	Giza	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	Shaimaa Mohamed Hamed

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	three months
Secondary	analysis of circulating ß-endorphin	assessment of circulating ß-endorphin was done before and after the treatment progam	three months