Back to resultsExtracorporeal Shock Wave Therapy for Dysmenorrhea
Primary Purpose
Primary Dysmenorrhea
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
shock wave therapy
dietary modification
Sponsored by
About this trial
This is an interventional treatment trial for Primary Dysmenorrhea
Eligibility Criteria
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
Sites / Locations
- MTI
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
shock wave
dietary modification
Arm Description
shock wave for primary dysmenorrhea for study group along side to dietary modification
dietary modification for primary dysmenorrhea for control group
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04662814
First Posted
November 22, 2020
Last Updated
March 20, 2021
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
1. Study Identification
Unique Protocol Identification Number
NCT04662814
Brief Title
Extracorporeal Shock Wave Therapy for Dysmenorrhea
Official Title
the Efficacy of Extracorporeal Shock Wave Therapy for Primary Dysmenorrhea
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 12, 2020 (Actual)
Primary Completion Date
December 24, 2020 (Actual)
Study Completion Date
January 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the 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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
group A: shockwave therapy and dietary modification group B: dietary modification
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
shock wave
Arm Type
Experimental
Arm Description
shock wave for primary dysmenorrhea for study group along side to dietary modification
Arm Title
dietary modification
Arm Type
Active Comparator
Arm Description
dietary modification for primary dysmenorrhea for control group
Intervention Type
Other
Intervention Name(s)
shock wave therapy
Intervention Description
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
Intervention Name(s)
dietary modification
Intervention Description
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 Outcome Measure Information:
Title
numerical rating scale
Description
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 Outcome Measure Information:
Title
prostaglandin
Description
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
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
MTI
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Extracorporeal Shock Wave Therapy for Dysmenorrhea
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