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Correlation Between Pelvic Pain, Low Back Pain, and Postural Stability in Healthy Young Women During the Menstrual Cycle

Sponsor
October 6 University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05767463
Collaborator
(none)
85
Enrollment
1
Location
4
Anticipated Duration (Months)
21
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Thirty-five female patients participated in this study. They were randomly assigned to the study. The outcome measures were pelvic pain assessed using the functional pelvic pain scale, low back pain assessed using the back pain functional scale, and postural stability assessed using the Biodex balance system.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    85 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Cross-Sectional
    Official Title:
    Correlation Between Pelvic Pain, Low Back Pain, and Postural Stability in Healthy Young Women During the Menstrual Cycle
    Actual Study Start Date :
    Nov 22, 2022
    Actual Primary Completion Date :
    Jan 20, 2023
    Anticipated Study Completion Date :
    Mar 25, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Functional pelvic pain scale [30 days]

      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.

    2. Back pain functional scale [30 days]

      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

    3. Postural stability by using Biodex Balance System [30 days]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 22 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. All young females will suffer from pelvic pain, low back pain, and postural instability during the menstrual cycle

    2. Age will range from 18 to 22 years

    3. All young females will have a BMI range from 25-30

    Exclusion Criteria:

    1. Lumbar spondylosis

    2. Lumbar disc prolapse

    3. Sacroiliac joint arthritis

    4. Low back trauma

    5. BMI more than 30

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 October 6 University Giza Egypt 12573

    Sponsors and Collaborators

    • October 6 University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hosam Magdy Metwally, Lecturer of physical therapy for neurology, October 6 University
    ClinicalTrials.gov Identifier:
    NCT05767463
    Other Study ID Numbers:
    • 2023
    First Posted:
    Mar 14, 2023
    Last Update Posted:
    Mar 14, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hosam Magdy Metwally, Lecturer of physical therapy for neurology, October 6 University
    Pelvic pain, low back pain
    Postural stability, and menstrual cycle
    Additional relevant MeSH terms:
    Back Pain
    Low Back Pain
    Pelvic Pain
    Dysmenorrhea

    Study Results

    No Results Posted as of Mar 14, 2023