Effect of Extracorporeal Shock Therapy for Dysmenorrhea

• ClinicalTrials.gov Identifier: NCT04741243
• Recruitment Status: Completed
• First Posted: February 5, 2021
• Last Update Posted: March 11, 2021
• Sponsor: Cairo University
• Collaborator: Shaimaa Mohamed Hamed
• Information provided by (Responsible Party): Ghada Ebrahim El Refaye, Cairo University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Primary Dysmenorrhea	Device: Extracorporeal Shock wave	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Randomization was done by sealed envelope
• Primary Purpose: Treatment
• Official Title: Effect of Extracorporeal Shock Therapy for Dysmenorrhea
• Actual Study Start Date: June 24, 2019
• Actual Primary Completion Date: November 30, 2020
• Actual Study Completion Date: December 1, 2020

Arms and Interventions

Arm	Intervention/treatment
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; 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 Name: dietary modification
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; 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 Name: dietary modification

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

1. analysis of circulating β-endorphin [ Time Frame: three months ]
   assessment of circulating β-endorphin was done before and after the treatment progam

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 35 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Egypt

Ghada Elrefaye

Giza, Cairo, Egypt, 12613

Sponsors and Collaborators

Cairo University

Shaimaa Mohamed Hamed

Investigators

• Principal Investigator: ghada eb elrefaye, professor; Cairo University

More Information

• 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
• ClinicalTrials.gov Identifier: NCT04741243
• Other Study ID Numbers: Cairo Un 99
• First Posted: February 5, 2021
• Last Update Posted: March 11, 2021
• Last Verified: March 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dysmenorrhea; Menstruation Disturbances; Pathologic Processes; Pelvic Pain; Pain; Neurologic Manifestations