Extracorporeal Shock Wave Therapy for Dysmenorrhea

Study Overview
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Brief Summary
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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
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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.

Official Title
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the Efficacy of Extracorporeal Shock Wave Therapy for Primary Dysmenorrhea

Conditions
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Primary Dysmenorrhea

Intervention / Treatment
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* Other: shock wave therapy
* Other: dietary modification


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: group A: shockwave therapy and dietary modification group B: dietary modification
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: shock wave<br>shock wave for primary dysmenorrhea for study group along side to dietary modification | Other: shock wave therapy<br>* 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.<br>Other: dietary modification<br>* 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<br>|
| Active Comparator: dietary modification<br>dietary modification for primary dysmenorrhea for control group | Other: dietary modification<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3months |