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Completed

NCT Number: NCT04741243

Effect of Extracorporeal Shock Therapy for Dysmenorrhea

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.

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Key information

Conditions

Primary Dysmenorrhea

Age range

25 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ghada Elrefaye

Giza, Cairo Governorate, 12613, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extracorporeal Shock wave

Device

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

Other names: dietary modification

Primary outcomes

  1. Visual Analogue Scale

    Time frame: 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 outcomes

  1. analysis of circulating β-endorphin

    Time frame: three months

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Shaimaa Mohamed Hamed

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 5, 2021
Registry last updated
Mar 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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