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Completed

NCT Number: NCT04662814

Extracorporeal Shock Wave Therapy for Dysmenorrhea

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

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Key information

Conditions

Primary Dysmenorrhea

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MTI

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ages ranged between18 - 25 years old.
  • body mass index (BMI) will not exceed 30kg/m2.
  • females will be diagnosed by the physician as primary dysmenorrhea.

Exclusion criteria

  • Secondary dysmenorrhea .
  • Mental health problem such as depression and anxiety.
  • Irregular periods

Treatment and study plan

shock wave therapy

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

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

Primary outcomes

  1. numerical rating scale

    Time frame: 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 outcomes

  1. prostaglandin

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

MTI University

Other

Collaborators

  • Ghada ebrahim El Refaye -Faculty of Physical Therapy, Cairo University, Egypt
  • Sohier Mahmmoud El Koseiry- Faculty of Physical Therapy, Cairo University, Egypt

Registry information

Official study title

the Efficacy of Extracorporeal Shock Wave Therapy for Primary Dysmenorrhea

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Dec 10, 2020
Registry last updated
Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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