Effect of Extracorporeal Shock Therapy for Dysmenorrhea

Not Applicable

Completed

• Conditions: Primary Dysmenorrhea
• Interventions: Device: Extracorporeal Shock wave

• Registration Number: NCT04741243
• Lead Sponsor: Cairo University

Brief 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.

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.

Study Timeline

• Study Start: 2019-06-24
• Primary Completion: 2020-11-30
• Study Completion: 2020-12-01
• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-05
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extracorporeal shock wave therapy	Extracorporeal Shock wave	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
dietary modification	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.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale	three months	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.

Secondary Outcome Measures

Name	Time	Method
analysis of circulating β-endorphin	three months	assessment of circulating β-endorphin was done before and after the treatment progam

Trial Locations

Locations (1)

Ghada Elrefaye; 🇪🇬 Giza, Cairo, Egypt