Primary DysmenorrheaNCT03802474
Biomechanical Assessment of Spinal Posture in Girls With Primary Dysmenorrhea
An observational study of Primary Dysmenorrhea, run by Cairo University.
Trial summary
Dysmenorrhea comes from the Greek word for difficult monthly flow and describes painful menstruation.Primary dysmenorrhea might be caused by spinal misalignment and incompatibility between muscles of the pelvic circumference and soft tissue.Leg Length Discrepancy affects spinal posture. Read more about this study
- Who is it for?
- Ages 17 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to Dec 2019
- How long will I take part?
- 1 Month
- 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 17 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy girls with regular menstrual cycle and are not have any pelvic or gynecological disorders will be participated in this study. All subjects will be recruited from student of faculty of physical therapy, Cairo University.
Who may be able to join
- Healthy girls with regular menstrual cycles with an average of 28:35 days.
- Their age will be ranged from 17to 24 years.
- Their body mass index will be ranged from 20 to 25kg/m2.
Who cannot join
- Girls who have musculoskeletal disorders as low back pain.
- Girls who have any pelvic or gynecological disorders.
- History of lower limb injury.
- Over-weight and obese girls.
- Thin and underweight girls.
- Girls with spinal deformities as kyphosis and scoliosis.
About this study
Dysmenorrhea comes from the Greek word for difficult monthly flow and describes painful menstruation.Primary dysmenorrhea might be caused by spinal misalignment and incompatibility between muscles of the pelvic circumference and soft tissue.Leg Length Discrepancy affects spinal posture. Although, several studies evaluated the relation between spinal alignment, spinal configuration and primary dysmenorrhea, but, there is no previous study investigate the effect of leg length discrepancy on primary dysmenorrhea. So, this study will correlate leg length discrepancy with spinal configuration and primary dysmenorrhea.
Statement of the problem:
Read more
Is there an impact of spinal posture on primary dysmenorrhea in girls?
Hypothesis:
Null hypothesis: There is no impact of spinal mobility ,spinal configurations and leg length discrepancy on primary dysmenorrhea
Read the detailed description
Primary dysmenorrhea is defined as painful menses in women with a normal pelvic anatomy. Adolescent girls tend to have a higher prevalence of primary dysmenorrhoea than older women, as primary dysmenorrhoea can improve with age.Asymmetry in upright posture is associated with various outcomes, such as the decreased loading of the affected side in stroke; degenerative changes of the hip, knee, and ankle joints and spine; or a leg length discrepancy.restriction of movement of the lumbosacral vertebrae, body fluid increases within the pelvis as well as contraction of the uterus leading to the intensification of the menstrual pain. Although, several studies evaluated the relation between spinal alignment, spinal configuration and primary dysmenorrhea, but, there is no previous study investigate the effect of leg length discrepancy on primary dysmenorrhea. So, this study will correlate leg length discrepancy with spinal configuration and primary dysmenorrhea.
One handred healthy girls with regular menstrual cycle and are not have any pelvic or gynecological disorders will be participated in this study. All subjects will be recruited from student of faculty of physical therapy, Cairo University.
- Personal data: All data will be recorded in a recording data sheet.
- Formetric Raster stereography: It will be used to assess spinal configuration (kyphotic angle, lordotic angle, pelvic inclination, trunk inclination and pelvic tilting) during menstruation.
- Leg length discrepancy Tape measure can be used to measure the true leg length from the anterior superior iliac spine to the medial malleolus. The functional leg length is measured from the umbilicus to medial malleolus.
- Inclinometer can be used to measure range of motion of lumbar spines.
- Conditions
- Primary Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | girls with primary dysmenorrhea subject to three-dimensional analysis of the back will conducted with the 4D formetric device and inclinometer to measure range of motion of spine | |
| Group B | girls with normal painless menstruation without primary dysmenorrhea subject to three-dimensional analysis of the back will conducted with the 4D formetric device and inclinometer to measure range of motion of spine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk inclination
the trunk inclination refer to the difference in height between VP and DM based on a vertical plane (sagital section).
an angle >2.8 referred to as " Inclination" (I), an angle <2.8 as "reclination" (R).
Measured: 1month
Kyphotic angle
this is the maximum kyphotic angle measured between the surface tangents of the upper inflection point ICT in the vicinity of the VP and the thoracic lumbar inflection point ITL.
Measured: 1 month
lateral deviation
the total deviation of the spinal midline from the VP-DM line in the frontal plane , i.e the maximum deflection on the right plus the maximum deflection on the left
Measured: 1 month
lordotic angle
this is the maximum lordotic angle measured between the surface tangents of the thoracic-lumbar inflection point ITL and the lower lumbar-sacral inflection point ILS
Measured: 1 month
pelvic inclination
this is calculated as the mean torsion of the DLand DR surface normals
Measured: 1 month
pelvic tilt
the difference in height of the lumbar dimples, based on a horizontal plane (transverse section ). DR is higher than DL if the angle is positive
Measured: 1 month
pelvic torsion
pelvic torsion is calculated from the reciprocal torsion of the surface normals on the two lumbar dimples (vertical components). If the difference angle is positive, then the normal on the right dimple (DR) is up more than on the left dimple.
Measured: 1 month
Secondary outcomes (1)
leg lenght discripancy
True leg length is measured from the anterior superior iliac spine to the medial malleolus. The functional leg length is measured from the umbilicus to medial malleolus.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study startJan 2019 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HAhmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802474
- Sponsor's protocol ID
- P.T.REC/012/002074
- Status last verified
- Sep 2018
- First submitted
- 10 Jan 2019
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Assessment of Spinal Posture in Girls With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT03802474
- Acronym / sponsor ID
- P.T.REC/012/002074
- Conditions
- Primary Dysmenorrhea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 14 Jan 2019 (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.
Dysmenorrhea comes from the Greek word for difficult monthly flow and describes painful menstruation.Primary dysmenorrhea might be caused by spinal misalignment and incompatibility between muscles of the pelvic circumference and soft tissue.Leg Length Discrepancy affects spinal posture. Although, several studies evaluated the relation between spinal alignment, spinal configuration and primary dysmenorrhea, but, there is no previous study investigate the effect of leg length discrepancy on primary dysmenorrhea. So, this study will correlate leg length discrepancy with spinal configuration and primary dysmenorrhea.
Statement of the problem:
Is there an impact of spinal posture on primary dysmenorrhea in girls?
Hypothesis:
Null hypothesis: There is no impact of spinal mobility ,spinal configurations and leg length discrepancy on primary dysmenorrhea
Detailed description
Primary dysmenorrhea is defined as painful menses in women with a normal pelvic anatomy. Adolescent girls tend to have a higher prevalence of primary dysmenorrhoea than older women, as primary dysmenorrhoea can improve with age.Asymmetry in upright posture is associated with various outcomes, such as the decreased loading of the affected side in stroke; degenerative changes of the hip, knee, and ankle joints and spine; or a leg length discrepancy.restriction of movement of the lumbosacral vertebrae, body fluid increases within the pelvis as well as contraction of the uterus leading to the intensification of the menstrual pain. Although, several studies evaluated the relation between spinal alignment, spinal configuration and primary dysmenorrhea, but, there is no previous study investigate the effect of leg length discrepancy on primary dysmenorrhea. So, this study will correlate leg length discrepancy with spinal configuration and primary dysmenorrhea.
One handred healthy girls with regular menstrual cycle and are not have any pelvic or gynecological disorders will be participated in this study. All subjects will be recruited from student of faculty of physical therapy, Cairo University.
- Personal data: All data will be recorded in a recording data sheet.
- Formetric Raster stereography: It will be used to assess spinal configuration (kyphotic angle, lordotic angle, pelvic inclination, trunk inclination and pelvic tilting) during menstruation.
- Leg length discrepancy Tape measure can be used to measure the true leg length from the anterior superior iliac spine to the medial malleolus. The functional leg length is measured from the umbilicus to medial malleolus.
- Inclinometer can be used to measure range of motion of lumbar spines.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –girls with primary dysmenorrhea subject to three-dimensional analysis of the back will conducted with the 4D formetric device and inclinometer to measure range of motion of spine |
| Group B | – | –girls with normal painless menstruation without primary dysmenorrhea subject to three-dimensional analysis of the back will conducted with the 4D formetric device and inclinometer to measure range of motion of spine |
Who may qualify
- Ages
- 17 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy girls with regular menstrual cycle and are not have any pelvic or gynecological disorders will be participated in this study. All subjects will be recruited from student of faculty of physical therapy, Cairo University.
Key inclusion criteria (3 listed)
- Healthy girls with regular menstrual cycles with an average of 28:35 days.
- Their age will be ranged from 17to 24 years.
- Their body mass index will be ranged from 20 to 25kg/m2.
Key exclusion criteria (6 listed)
- Girls who have musculoskeletal disorders as low back pain.
- Girls who have any pelvic or gynecological disorders.
- History of lower limb injury.
- Over-weight and obese girls.
- Thin and underweight girls.
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
Trunk inclination
Time frame: 1month
the trunk inclination refer to the difference in height between VP and DM based on a vertical plane (sagital section). an angle >2.8 referred to as " Inclination" (I), an angle <2.8 as "reclination" (R).
Kyphotic angle
Time frame: 1 month
this is the maximum kyphotic angle measured between the surface tangents of the upper inflection point ICT in the vicinity of the VP and the thoracic lumbar inflection point ITL.
lateral deviation
Time frame: 1 month
the total deviation of the spinal midline from the VP-DM line in the frontal plane , i.e the maximum deflection on the right plus the maximum deflection on the left
lordotic angle
Time frame: 1 month
this is the maximum lordotic angle measured between the surface tangents of the thoracic-lumbar inflection point ITL and the lower lumbar-sacral inflection point ILS
pelvic inclination
Time frame: 1 month
this is calculated as the mean torsion of the DLand DR surface normals
pelvic tilt
Time frame: 1 month
the difference in height of the lumbar dimples, based on a horizontal plane (transverse section ). DR is higher than DL if the angle is positive
pelvic torsion
Time frame: 1 month
pelvic torsion is calculated from the reciprocal torsion of the surface normals on the two lumbar dimples (vertical components). If the difference angle is positive, then the normal on the right dimple (DR) is up more than on the left dimple.
1 secondary outcome
leg lenght discripancy
Time frame: 1 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Dysmenorrhea, run by Cairo University.
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 6 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 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Trunk inclination (time frame: 1month). The study lists 7 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 Jan 2019.