NCT06762106

Brief Summary

Primary dysmenorrhea (PD), defined as menstrual pain without any structural lesions, usually begins shortly before or immediately after the onset of the menstrual cycle and commonly lasts for 48 to 72 hour

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

December 30, 2024

Last Update Submit

January 4, 2025

Conditions

DysmenorrheaBack Pain Lower Back

Keywords

dysmenorrhealower back painshock wave

Outcome Measures

Primary Outcomes (1)

  • Pain assessment

    VAS scoring method. 0 is the least while 10 is the highest

    every month for three menstrual cycle

Study Arms (2)

Hot back group

ACTIVE COMPARATOR

30 subjects were treated by hot back in the first 3 days of the menstrual cycle (follicular phase) for three consecutive menstrual cycles

Radiation: hot back

shock wave and hot back group

EXPERIMENTAL

30 subjects were treated by hot back and shockwave therapy in the first 3 days of the menstrual cycle (follicular phase) for three consecutive menstrual cycles

Radiation: shockwave therapy

Interventions

shockwave therapyRADIATION

solid unite made with metal frame and case

shock wave and hot back group
hot backRADIATION

thermal hot back

Hot back group

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsas menstruation is found only in females
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Their ages ranged from 18 to 30 years.
  • Their BMI were not exceeding 29 Kg/m2.
  • All patients were clinically diagnosed as low back pain during Primary Dysmenorrhea according to the Primary Dysmenorrhea Consensus Guideline

You may not qualify if:

  • Any known chronic disease (such as cardiovascular or renal diseases) or secondary dysmenorrhea.
  • Being pregnant or planning to get pregnant any time during the trial.
  • Having received other treatments for PD in the past half year.
  • Irregular menstrual cycles.
  • Mental or neurological disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia

Minya, 05637, Egypt

Location

MeSH Terms

Conditions

DysmenorrheaLow Back Pain

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and SymptomsBack Pain

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2024

First Posted

January 7, 2025

Study Start

September 10, 2023

Primary Completion

March 2, 2024

Study Completion

January 1, 2025

Last Updated

January 7, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)