- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04820816
Effect of Posterior Pelvic Tilt on Balance and Sensory Integration in Patients With Non-specific Low Back Pain
Effect of Posterior Pelvic Tilt on Balance, Sensory Integration and Risk of Fall in Patients With Non-specific Low Back Pain
Study Overview
Status
Intervention / Treatment
Detailed Description
The LBP became one of the biggest problems for public health systems in the world during the second half of the 20th century. The lifetime prevalence of LBP is reported to be as high as 84%, and the prevalence of chronic LBP is about 23%, with 11-12% of the population being disabled by LBP. Prevalence of LBP was 53.2%. It was more among female patients (62.8%) than among male patients (38.3%) among attendants to a Family Health Center in Egypt.
Additionally, studies have observed relationships between chronic non-specific LBP and a posteriorly shifted center of gravity, impaired proprioception, and decreased muscular strength, activation and endurance of the trunk and hips. Balance is impaired in individuals with chronic low back pain when compared to healthy individuals.
Most of these studies supposed that postural mal-alignment involves deviations in only one direction which is toward lordosis and anterior pelvic tilt. However, clinical experience suggests that some patients with back pain have the opposite problem which is a much reduced lordotic curve and a posterior pelvic tilt. If the true relationship between posture and low back pain disability is curvilinear instead, this could explain why the studies so far have shown weak or no relationships.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Noha Abbas, Bachelor
- Phone Number: 00201060742720
- Email: Noha.Abbas@pt.mti.edu.eg
Study Contact Backup
- Name: Rania Reda, PhD
- Phone Number: 00201273325285
- Email: raniareda22@hotmail.com
Study Locations
-
-
-
Cairo, Egypt, 1069
- Recruiting
- Noha Abbas Abdelaziz Ali
-
Contact:
- Noha Abbas
- Phone Number: 01060742720
- Email: Noha.Abbas@pt.mti.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Fifty patients with chronic low back pain or repeated non-specific back pain for more than three months.
- Both sex with posterior pelvic tilt (-0.7 ± 6.5°)and decreased lumbar lordosis, for (Group A) and normal anterior pelvic tilt angle between 5° and 13° for (Group B)
- Their ages were ranged from 20-35 years.
- Body Mass Index from 18-25 Kg/m² .
Exclusion Criteria:
- Previous back surgery.
- Signs and symptoms of gross spinal instability.
- Radiological diagnosis of spondylolysis or spondylolisthesis.
- Acute low back pain.
- Disc prolapse or herniation.
- Any neurological, orthopedic, and vestibular disorders affecting the balance system.
- Flexion and extension restriction of the lumbar region.
- Other conditions that affected the normal functioning of the central and peripheral nervous system such as alcohol abuse, addiction, dementia, and cognitive disorders.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Posterior pelvic tilt group
|
BIODEX balance system, Limits of stability test, Risk of Fall test, m-CTSIB test
|
Normal anterior pelvic tilt group
|
BIODEX balance system, Limits of stability test, Risk of Fall test, m-CTSIB test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biodex balance system Limits of stability test
Time Frame: 10 minuets
|
A test measures dynamic postural stability in percentage
|
10 minuets
|
Biodex balance system m-CTSIB test
Time Frame: 10 minuets
|
A test measures postural sway control to assess sensory integration.
|
10 minuets
|
Biodex balance system Fall risk test (FR)
Time Frame: 10 minuets
|
A test to assess risk of fall according to mean age
|
10 minuets
|
Oswestry Disability Index (ODI)
Time Frame: 10 minuets
|
An index to assess physical functioning in percentage.
|
10 minuets
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Global Posture System (GPS) 600
Time Frame: 10 minuets
|
A device to assess degree of pelvic tilt angle in degrees.
|
10 minuets
|
Body Mass Index (weight in kilograms, height in meters)
Time Frame: 10 minuets
|
kg/m^2
|
10 minuets
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Noha Abbas, MSc, MTI University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 012-003133
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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