Extracorporeal Shock Wave Therapy for Dysmenorrhea

NCT04662814 | Completed

• 1 other identifier: mtiu
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Primary Dysmenorrhea

Outcome Measures

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)

  3 months

Secondary Outcomes (1)

• prostaglandin

  3months

Study Arms (2)

shock wave

EXPERIMENTAL

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

Other: shock wave therapy; Other: dietary modification

dietary modification

ACTIVE COMPARATOR

dietary modification for primary dysmenorrhea for control group

Other: dietary modification

Interventions

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.

shock wave

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

dietary modification; shock wave

Eligibility Criteria

• Age: 18 Years - 25 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

MTI

Cairo, Egypt

Location

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy; Diet Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation; Nutrition Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: group A: shockwave therapy and dietary modification group B: dietary modification

Study Record Dates

• First Submitted: November 22, 2020
• First Posted: December 10, 2020
• Study Start: September 12, 2020
• Primary Completion: December 24, 2020
• Study Completion: January 27, 2021
• Last Updated: March 24, 2021

Record last verified: 2021-03

Locations

EG (1)