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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05767463
Other study ID # 2023
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 22, 2022
Est. completion date March 25, 2023

Study information

Verified date March 2023
Source October 6 University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 85
Est. completion date March 25, 2023
Est. primary completion date January 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 22 Years
Eligibility 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

Study Design


Locations

Country Name City State
Egypt October 6 University Giza

Sponsors (1)

Lead Sponsor Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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