NCT05767463

Brief Summary

The menstrual cycle is governed by hormonal changes. Each cycle can be divided into three phases based on events in the ovary (ovarian cycle) or in the uterus (uterine cycle). H0: There will be no correlation between pelvic pain and postural stability in healthy young women during the menstrual cycle H0: There will be no correlation between low back pain and postural stability in healthy young women during the menstrual cycle H0: There will be no correlation between pelvic pain and low back pain in healthy young women during the menstrual cycle

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 1, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2023

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

March 1, 2023

Last Update Submit

March 10, 2023

Conditions

Keywords

Pelvic pain, low back painPostural stability, and menstrual cycle

Outcome Measures

Primary Outcomes (3)

  • Functional pelvic pain scale

    Functional Pelvic Pain Scale, designed to measure pelvic pain intensity as it relates to functions of daily living (bladder and bowel function, intercourse, walking, running, lifting, working, and sleeping),a total score is summed up out of 32. Furthermore, the maximum score obtained indicates the maximum physical disabilities of the patients. In addition, this scale also has an 'Adjusted score' ranging from 0 (0%)- no pain, normal function to 32 (100%)-cannot function because of pain.

    30 days

  • Back pain functional scale

    The Back Pain Functional Scale is a subjective scale used to measure the patient's physical function after low back pain. This scale was developed by Stratford et al. (2000), a total score is summed up out of 60. Furthermore, the maximum score obtained indicates the maximum physical abilities of the patients. In addition, this scale also has an 'Adjusted score' ranging from 0 (0%)-unable to perform any activity to 60 (100%)-no difficulty in any activity

    30 days

  • Postural stability by using Biodex Balance System

    The Biodex Balance System (BBS) has been used to evaluate postural balance. The BBS is a multiaxial device that objectively measures and records an individual's ability to stabilize the involved joint under dynamic stress

    30 days

Eligibility Criteria

Age18 Years - 22 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

All young females will be recruited from the physical therapy faculty, October 6 University. All the assessment measurements will be done at the faculty of physical therapy, on October 6 University

You may qualify if:

  • All young females will suffer from pelvic pain, low back pain, and postural instability during the menstrual cycle
  • Age will range from 18 to 22 years
  • All young females will have a BMI range from 25-30

You may not qualify if:

  • Lumbar spondylosis
  • Lumbar disc prolapse
  • Sacroiliac joint arthritis
  • Low back trauma
  • BMI more than 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October 6 University

Giza, 12573, Egypt

Location

MeSH Terms

Conditions

DysmenorrheaPelvic PainLow Back Pain

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsBack Pain

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy for neurology

Study Record Dates

First Submitted

March 1, 2023

First Posted

March 14, 2023

Study Start

November 22, 2022

Primary Completion

January 20, 2023

Study Completion

March 25, 2023

Last Updated

March 14, 2023

Record last verified: 2023-03

Locations