Extracorporeal Shock Wave Therapy for Dysmenorrhea

NCT ID: NCT04662814

Last Updated: 2021-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-12
• Study Completion Date: 2021-01-27

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.

Conditions

Primary Dysmenorrhea

Study Design

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

Study Groups

shock wave

shock wave for primary dysmenorrhea for study group along side to dietary modification

Group Type: EXPERIMENTAL

shock wave therapy

Intervention Type: OTHER

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

Intervention Type: OTHER

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

dietary modification

dietary modification for primary dysmenorrhea for control group

Group Type: ACTIVE_COMPARATOR

dietary modification

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ghada ebrahim El Refaye -Faculty of Physical Therapy, Cairo University, Egypt

UNKNOWN

Sponsor Role: collaborator

Sohier Mahmmoud El Koseiry- Faculty of Physical Therapy, Cairo University, Egypt

UNKNOWN

Sponsor Role: collaborator

MTI University

OTHER

Sponsor Role: lead

Responsible Party

shaimaa Mohamed hamed

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

MTI

Cairo, , Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

mtiu

Identifier Type: -

Identifier Source: org_study_id