Extracorporeal Shock Wave Therapy for Dysmenorrhea

Primary Dysmenorrhea Clinical Trial

Official title:

the Efficacy of Extracorporeal Shock Wave Therapy for Primary Dysmenorrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04662814
• Other study ID #: mtiu
• Status: Completed
• Phase: N/A
• Start date: September 12, 2020
• Est. completion date: January 27, 2021

Study information

• Verified date: March 2021
• Source: MTI University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

purpose of this study to investigate the effect of Extracorporeal shock wave therapy on pain and prostaglandin level in patient with primary dysmenorrhea

Description:

This randomized controlled trial is to determine the effect of shock wave therapy in the treatment of primary dysmenorrhea.

females are randomly assigned into 2 groups: group A SWT treatment plus dietary modification during PD (n=25） GROUP B:dietary modification only (n=25）;

Participants in group B will receive dietary modification for three successive months

The numerical rating scale (NRS) and prostaglandin blood level will be recorded and evaluated before and after treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 27, 2021
• Est. primary completion date: December 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

1. ages ranged between18 - 25 years old.

2. body mass index (BMI) will not exceed 30kg/m2.

3. females will be diagnosed by the physician as primary dysmenorrhea.

Exclusion Criteria:

1. Secondary dysmenorrhea .

2. Mental health problem such as depression and anxiety.

3. Irregular periods

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Other:
• shock wave therapy
Intervention group is by shock wave therapy. A radial shock wave device (EME, ITALY) was used. for 4 sessions (one session before the expected day of period and session per day for day1 , day 2 and day 3 of each menstrual cycle) for three successive periods.
• dietary modification
Participants will receive dietary modification for three consecutive months dietary modification will be low caffeine and high water and liquids intake and reduce the uptake of fast food, should be followed for 3 months

Locations

Country	Name	City	State
Egypt	MTI	Cairo

Sponsors (3)

Lead Sponsor	Collaborator
MTI University	Ghada ebrahim El Refaye -Faculty of Physical Therapy, Cairo University, Egypt, Sohier Mahmmoud El Koseiry- Faculty of Physical Therapy, Cairo University, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	numerical rating scale	Numeric rating scale will be 10 cm digital line with 0 (zero) representing feeling no pain and 10 representing feeling the worst pain, was used to assess the severity of the pain before and after treatment for all females in both groups (A&B).; measurement will done twice first one at baseline(will be considered as pre treatment measure) and 2nd on e at 3rd menstrual cycle ( will be considered as post treatment measure)	3 months
Secondary	prostaglandin	5cm plasma concentrations of prostaglandin F2a was taken from all females and was analyzed in the Laboratory index to determine the prostaglandin plasma level; measurement will done twice before after the treatment program.	3months