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CompletedNCT04662814Updated Mar 24, 2021

Extracorporeal Shock Wave Therapy for Dysmenorrhea

An interventional study of shock wave therapy and dietary modification in Primary Dysmenorrhea, sponsored by MTI University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-24.

Sponsored by MTI University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Primary Dysmenorrhea

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03

In context

Dysmenorrhea

398 studies on the registry are indexed under Dysmenorrhea; 96 are open to participants now.

This study's enrollment of 50 is below the median of 60 across 333 interventional studies indexed under Dysmenorrhea.

Browse Dysmenorrhea studies →

Lead sponsor

MTI University is the lead sponsor of 58 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  1. Secondary dysmenorrhea .
  2. Mental health problem such as depression and anxiety.
  3. Irregular periods
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    shock wave

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

    Other: shock wave therapy · Other: dietary modification

  • Active comparator
    dietary modification

    dietary modification for primary dysmenorrhea for control group

    Other: dietary modification

Interventions

  • Othershock 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.

  • Otherdietary 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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 3 months

Secondary outcomes

  1. prostaglandin

    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.

    Time frame: 3months

07

Study locations

1 site
  • MTI
    Cairo, Egypt
08

References and documents

Study documents

  • Protocol and informed consent form · Jun 1, 2019

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04662814
Lead sponsor
MTI University
Collaborators
Ghada ebrahim El Refaye -Faculty of Physical Therapy, Cairo University, Egypt, Sohier Mahmmoud El Koseiry- Faculty of Physical Therapy, Cairo University, Egypt
Responsible party
shaimaa Mohamed hamed (principle investigator, MTI University) — Principal investigator
First posted
Dec 10, 2020
Start date
Sep 12, 2020
Primary completion
Dec 24, 2020
Completion
Jan 27, 2021
Last update
Mar 24, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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