Effect of Extracorporeal Shock Therapy for Dysmenorrhea

NCT04741243 | Completed

• 1 other identifier: Cairo Un 99
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Dysmenorrhea

Outcome Measures

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.

  three months

Secondary Outcomes (1)

• analysis of circulating β-endorphin

  three months

Study Arms (2)

Extracorporeal shock wave therapy

EXPERIMENTAL

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 modification

EXPERIMENTAL

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

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

Also known as: dietary modification

Extracorporeal shock wave therapy; dietary modification

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead
• Shaimaa Mohamed Hamed: collaborator

Study Sites (1)

Ghada Elrefaye

Giza, Cairo Governorate, 12613, Egypt

Location

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy; Diet Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation; Nutrition Therapy

Study Officials

• ghada eb elrefaye, professor

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomization was done by sealed envelope
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 5, 2021
• Study Start: June 24, 2019
• Primary Completion: November 30, 2020
• Study Completion: December 1, 2020
• Last Updated: March 11, 2021

Record last verified: 2021-03

Locations

EG (1)