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Effect of Extracorporeal Shock Therapy for Dysmenorrhea

Primary Purpose

Primary Dysmenorrhea

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Extracorporeal Shock wave
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Ghada Elrefaye

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Extracorporeal shock wave therapy

dietary modification

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 2, 2021
Last Updated
March 9, 2021
Sponsor
Cairo University
Collaborators
Shaimaa Mohamed Hamed
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1. Study Identification

Unique Protocol Identification Number
NCT04741243
Brief Title
Effect of Extracorporeal Shock Therapy for Dysmenorrhea
Official Title
Effect of Extracorporeal Shock Therapy for Dysmenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Shaimaa Mohamed Hamed

4. Oversight

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

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Randomization was done by sealed envelope
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extracorporeal shock wave therapy
Arm Type
Experimental
Arm Description
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
Arm Title
dietary modification
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Extracorporeal Shock wave
Other Intervention Name(s)
dietary modification
Intervention Description
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 Measure Information:
Title
Visual Analogue Scale
Description
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.
Time Frame
three months
Secondary Outcome Measure Information:
Title
analysis of circulating β-endorphin
Description
assessment of circulating β-endorphin was done before and after the treatment progam
Time Frame
three months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ghada eb elrefaye, professor
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghada Elrefaye
City
Giza
State/Province
Cairo
ZIP/Postal Code
12613
Country
Egypt

12. IPD Sharing Statement

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Effect of Extracorporeal Shock Therapy for Dysmenorrhea

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