Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04377373
Other study ID # P.T.REC/012/002300
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 14, 2019
Est. completion date September 5, 2019

Study information

Verified date May 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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:

A. 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 FergusonĀ“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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date September 5, 2019
Est. primary completion date August 15, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria:

1. Female with bilateral genu valgum (Q angle> 20 degrees.

2. Age ranges from 18-25 years old.

3. BMI = 30 (kg/m2)

Exclusion Criteria:

1. Previous lumbar surgery

2. lumbar spine fracture

3. Spondylolisthesis

4. Foraminal or extra foraminal lumbar disc herniation

5. spinal tumors, and bone metabolic diseases 6 - Knee surgeries

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Cairo university Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
30 minutes
Primary 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.
15 minutes
See also
  Status Clinical Trial Phase
Completed NCT05241691 - Retrospective Evaluation of GGPSP's Safety and Clinical Performance for the Treatment of Lower Limbs Deformities.