Extracorporeal Shock Wave Therapy for Dysmenorrhea

Not Applicable

Completed

• Conditions: Primary Dysmenorrhea
• Interventions: Other: shock wave therapy; Other: dietary modification

• Registration Number: NCT04662814
• Lead Sponsor: MTI University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2020-09-12
• Study First Submitted: 2020-11-22
• Study First Submitted QC: 2020-12-04
• Study First Posted: 2020-12-10
• Primary Completion: 2020-12-24
• Study Completion: 2021-01-27
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-20
• Last Update Posted: 2021-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
shock wave	shock wave therapy	shock wave for primary dysmenorrhea for study group along side to dietary modification
dietary modification	dietary modification	dietary modification for primary dysmenorrhea for control group
shock wave	dietary modification	shock wave for primary dysmenorrhea for study group along side to dietary modification

Primary Outcome Measures

Name	Time	Method
numerical rating scale	3 months	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)

Secondary Outcome Measures

Name	Time	Method
prostaglandin	3months	5cm plasma concentrations of prostaglandin F2α 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.

Trial Locations

Locations (1)

MTI; 🇪🇬 Cairo, Egypt