Pain, MenstrualNCT05767463
Correlation Between Pelvic Pain, Low Back Pain, and Postural Stability in Healthy Young Women During the Menstrual Cycle
An observational study of Pain, Menstrual, run by October 6 University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 to 22 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Menstrual
- How many people
- 85 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Nov 2022to 25 Mar 2023
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 22 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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
Who cannot join
- Lumbar spondylosis
- Lumbar disc prolapse
- Sacroiliac joint arthritis
- Low back trauma
- BMI more than 30
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Pain, Menstrual
- Keywords
- Pelvic pain, low back pain, Postural stability, and menstrual cycle
- Medical subject headings
- Dysmenorrhea, Pelvic Pain, Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start22 Nov 2022
- Primary completion20 Jan 2023
- Study completion25 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, MenstrualStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hosam Magdy Metwally, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767463
- Sponsor's protocol ID
- 2023
- Status last verified
- Mar 2023
- First submitted
- 1 Mar 2023
- Last updated
- 14 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Pelvic Pain, Low Back Pain, and Postural Stability in Healthy Young Women During the Menstrual Cycle
- ClinicalTrials.gov ID
- NCT05767463
- Acronym / sponsor ID
- 2023
- Conditions
- Pain, Menstrual
- Keywords
- Pelvic pain, low back pain, Postural stability, and menstrual cycle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 25 Mar 2023 (estimated)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 to 22 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Lumbar spondylosis
- Lumbar disc prolapse
- Sacroiliac joint arthritis
- Low back trauma
- BMI more than 30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional pelvic pain scale
Time frame: 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.
Back pain functional scale
Time frame: 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
Postural stability by using Biodex Balance System
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Menstrual, run by October 6 University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional pelvic pain scale (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.