Effect of Extracorporeal Shock Therapy for Dysmenorrhea

NCT ID: NCT04741243

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-24
• Study Completion Date: 2020-12-01

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.

Conditions

Primary Dysmenorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Extracorporeal Shock wave

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Extracorporeal Shock wave

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

dietary modification

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Shaimaa Mohamed Hamed

UNKNOWN

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ghada Ebrahim El Refaye

assistant professor Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ghada eb elrefaye, professor

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Ghada Elrefaye

Giza, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

Cairo Un 99

Identifier Type: -

Identifier Source: org_study_id