Genu ValgumNCT04377373
Correlation Between Sacral Angle and Lumbar Range of Motion in Women With Genu Valgum
An observational study of Genu Valgum, run by Cairo University at 1 site in Egypt.
Trial summary
Many patients with genu valgum present with postural changes, such as: internal rotation of the tibial and femoral axes, anteversion of the iliac bones, increased lumbar lordosis, thoracic hyperkyphosis and cervical hyperlordosis. Such pathomechanical changes may interfere with lumbar range of motion. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Genu Valgum
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Apr 2019to 5 Sep 2019
- 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 25 years
- Women only
- No healthy volunteers
- Adult
Study population: Female with bilateral genu valgum with age range 18-25 and BMI≥ 30 (kg/m2)
Who may be able to join
- Female with bilateral genu valgum (Q angle> 20 degrees.
- Age ranges from 18-25 years old.
- BMI ≥ 30 (kg/m2)
Who cannot join
- Previous lumbar surgery
- lumbar spine fracture
- Spondylolisthesis
- Foraminal or extra foraminal lumbar disc herniation
- spinal tumors, and bone metabolic diseases 6 - Knee surgeries
Trial locations and contacts
1 site in 1 country.
About this study
Many patients with genu valgum present with postural changes, such as: internal rotation of the tibial and femoral axes, anteversion of the iliac bones, increased lumbar lordosis, thoracic hyperkyphosis and cervical hyperlordosis. Such pathomechanical changes may interfere with lumbar range of motion. Investigators of this study try to answer the following question: is there a relationship between sacral angle and lumbar range of motion in women with bilateral genu valgum. the results of this study will help professionals to plan a proper treatment program for patients with genu valgum.
Read the detailed description
Sixty four female participants were under the following procedures:
- Screening for genu valgum via postural assessment from frontal view, then measuring the Q angle bilaterally.
- Patients with Q-angle >20 degress were under the following procedures:
- Full-Length AP standing X-ray,then the investigators measured the hip-knee angle (the angle between the mechanical axis of the femur and the tibia). It will be obtained by connecting the center of the femoral head to the midpoint of the tibial eminential spine in a line tangential to the femoral condyles, and another line from here to the centre of the trochlea tali.
B-Lumbo-sacral X-ray lateral view was done at the time and the sacral angle was the measured by Ferguson´s technique in degrees using a protractor and this was the sacral angle.
C- During the same session, trunk range of motion was measured by Modified schober test D- Collected data were taken for statistical analysis.
- Conditions
- Genu Valgum
- Medical subject headings
- Genu Valgum
What is being measured
The primary outcome is the main question the study is designed to answer.
Sacral angle
After X-ray lateral view for lumbo-sacral spine, the investigators used a 30 cm long transparent ruler to measure the sacral angle on the X-ray film.
Two lines were drawn, the first line along the superior margin of the sacrum, and the second line was the horizontal line.
The acute angle between 2 lines(sacral angle) was measured in degrees using a protractor.
Measured: 30 minutes
Lumbar range of motion measured by Modified Shobber test
- Patient was directed to stand with the back exposed.
- Dimples of Venus (posterior superior iliac spine) was determined and was marked by pertinent marker.
- Using tape measurement, the researcher marked a point 5 cm below and 10 cm above marked dimples (total marked area was 15 cm).
- Then the subject was asked to lean forward without bending the knees.
- The distance between 2 points was measured (D), then the ROM was determined by the following equation; ROM = D -15.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start14 Apr 2019
- Primary completion15 Aug 2019
- Study completion5 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genu ValgumStudies 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karima Abdelaty Hassan, Cairo University
- Investigators
- Nasr A. Abdelkader, PhD, Principal investigator, Lecturer,Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377373
- Sponsor's protocol ID
- P.T.REC/012/002300
- Status last verified
- May 2020
- First submitted
- 6 Sep 2019
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Sacral Angle and Lumbar Range of Motion in Women With Genu Valgum
- ClinicalTrials.gov ID
- NCT04377373
- Acronym / sponsor ID
- P.T.REC/012/002300
- Conditions
- Genu Valgum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 14 Apr 2019 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 6 May 2020 (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.
Many patients with genu valgum present with postural changes, such as: internal rotation of the tibial and femoral axes, anteversion of the iliac bones, increased lumbar lordosis, thoracic hyperkyphosis and cervical hyperlordosis. Such pathomechanical changes may interfere with lumbar range of motion. Investigators of this study try to answer the following question: is there a relationship between sacral angle and lumbar range of motion in women with bilateral genu valgum. the results of this study will help professionals to plan a proper treatment program for patients with genu valgum.
Detailed description
Sixty four female participants were under the following procedures:
- Screening for genu valgum via postural assessment from frontal view, then measuring the Q angle bilaterally.
- Patients with Q-angle >20 degress were under the following procedures:
- Full-Length AP standing X-ray,then the investigators measured the hip-knee angle (the angle between the mechanical axis of the femur and the tibia). It will be obtained by connecting the center of the femoral head to the midpoint of the tibial eminential spine in a line tangential to the femoral condyles, and another line from here to the centre of the trochlea tali.
B-Lumbo-sacral X-ray lateral view was done at the time and the sacral angle was the measured by Ferguson´s technique in degrees using a protractor and this was the sacral angle.
C- During the same session, trunk range of motion was measured by Modified schober test D- Collected data were taken for statistical analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female with bilateral genu valgum with age range 18-25 and BMI≥ 30 (kg/m2)
Key inclusion criteria (3 listed)
- Female with bilateral genu valgum (Q angle> 20 degrees.
- Age ranges from 18-25 years old.
- BMI ≥ 30 (kg/m2)
Key exclusion criteria (5 listed)
- Previous lumbar surgery
- lumbar spine fracture
- Spondylolisthesis
- Foraminal or extra foraminal lumbar disc herniation
- spinal tumors, and bone metabolic diseases 6 - Knee surgeries
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
Sacral angle
Time frame: 30 minutes
After X-ray lateral view for lumbo-sacral spine, the investigators used a 30 cm long transparent ruler to measure the sacral angle on the X-ray film. Two lines were drawn, the first line along the superior margin of the sacrum, and the second line was the horizontal line. The acute angle between 2 lines(sacral angle) was measured in degrees using a protractor.
Lumbar range of motion measured by Modified Shobber test
Time frame: 15 minutes
* Patient was directed to stand with the back exposed. * Dimples of Venus (posterior superior iliac spine) was determined and was marked by pertinent marker. * Using tape measurement, the researcher marked a point 5 cm below and 10 cm above marked dimples (total marked area was 15 cm). * Then the subject was asked to lean forward without bending the knees. * The distance between 2 points was measured (D), then the ROM was determined by the following equation; ROM = D -15.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
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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.
Nasr A. Abdelkader, PhD principal investigator
Lecturer,Cairo University
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 Genu Valgum, run by Cairo 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: finished, as of the sponsor's last update on 6 May 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sacral angle (time frame: 30 minutes). The study lists 2 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 6 May 2020.