Biochemical Lesions Lumbar RegionNCT04820816
Effect of Posterior Pelvic Tilt on Balance and Sensory Integration in Patients With Non-specific Low Back Pain
An observational study of Biochemical Lesions Lumbar Region and Orthopedic Disorder of Spine, run by MTI University at 1 site in Egypt.
Trial summary
There is a debate in the literature about the effect of NSLBP on pelvic tilt and its effect on balance, sensory integration and functional disability so we need this study to fill the aforementioned gap in literature in this field. Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Biochemical Lesions Lumbar Region, Orthopedic Disorder of Spine, Back Disorder
- What is being tested?
- pelvic tilt effect on balance, sensory integration and risk of fall
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 15 Apr 2021
- How long will I take part?
- 1 Day
- 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 20 to 35 years
- All sexes
- No healthy volunteers
- Adult
Study population: Fifty patients with chronic low back pain or repeated non-specific back pain for more than three months and referred from a physician with anterior or posterior pelvic tilt angles according to the groups.
Who may be able to join
- 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 .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Noha Abbas Abdelaziz Ali
Cairo, 1069
Noha Abbas, 01060742720, Noha.Abbas@pt.mti.edu.eg
About this study
Official title: Effect of Posterior Pelvic Tilt on Balance, Sensory Integration and Risk of Fall in Patients With Non-specific Low Back Pain
There is a debate in the literature about the effect of NSLBP on pelvic tilt and its effect on balance, sensory integration and functional disability so we need this study to fill the aforementioned gap in literature in this field. So the purpose of the study is to evaluate posterior pelvic tilt effect on overall dynamic balance, sensory integration and functional disability in patients with non-specific low back pain.
Read the 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.
- Being tested
- pelvic tilt effect on balance, sensory integration and risk of fall
- Keywords
- pelvic tilt, sensory integration, balance, back pain, biodex
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic tilt effect on balance, sensory integration and risk of fallOther
BIODEX balance system, Limits of stability test, Risk of Fall test, m-CTSIB test
| Study group | Role | What they receive |
|---|---|---|
| Posterior pelvic tilt group | 1. patients with chronic low back pain or repeated non-specific back pain for more than three months.
2. Both sex with posterior pelvic tilt (-0.7 ± 6.5°) and decreased lumbar lordosis
3. Their ages were ranged from 20-35 years
4. Body Mass Index from 18-25 Kg/m² Receives: Other: pelvic tilt effect on balance, sensory integration and risk of fall | |
| Normal anterior pelvic tilt group | 1. patients with chronic low back pain or repeated non-specific back pain for more than three months.
2. Both sex with anterior pelvic tilt (5° and 13°) and normal lumbar lordosis
3. Their ages were ranged from 20-35 years
4. Body Mass Index from 18-25 Kg/m² Receives: Other: pelvic tilt effect on balance, sensory integration and risk of fall |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodex balance system Limits of stability test
A test measures dynamic postural stability in percentage
Measured: 10 minuets
Biodex balance system m-CTSIB test
A test measures postural sway control to assess sensory integration.
Measured: 10 minuets
Biodex balance system Fall risk test (FR)
A test to assess risk of fall according to mean age
Measured: 10 minuets
Oswestry Disability Index (ODI)
An index to assess physical functioning in percentage.
Measured: 10 minuets
Secondary outcomes (2)
The Global Posture System (GPS) 600
A device to assess degree of pelvic tilt angle in degrees.
Measured: 10 minuets
Body Mass Index (weight in kilograms, height in meters)
kg/m^2
Measured: 10 minuets
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start1 Sep 2020
- Primary completion1 Apr 2021 (estimated)
- Study completion15 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biochemical Lesions Lumbar RegionStudies 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
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Abbas Abdelaziz Ali, MTI University
- Investigators
- Noha Abbas, MSc, Study chair, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820816
- Sponsor's protocol ID
- 012-003133
- Status last verified
- Mar 2021
- First submitted
- 20 Mar 2021
- Last updated
- 29 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Posterior Pelvic Tilt on Balance, Sensory Integration and Risk of Fall in Patients With Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT04820816
- Acronym / sponsor ID
- 012-003133
- Keywords
- pelvic tilt, sensory integration, balance, back pain, biodex
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 15 Apr 2021 (estimated)
- First posted
- 29 Mar 2021 (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.
There is a debate in the literature about the effect of NSLBP on pelvic tilt and its effect on balance, sensory integration and functional disability so we need this study to fill the aforementioned gap in literature in this field. So the purpose of the study is to evaluate posterior pelvic tilt effect on overall dynamic balance, sensory integration and functional disability in patients with non-specific low back pain.
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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior pelvic tilt group | – | Other: pelvic tilt effect on balance, sensory integration and risk of fall1. patients with chronic low back pain or repeated non-specific back pain for more than three months. 2. Both sex with posterior pelvic tilt (-0.7 ± 6.5°) and decreased lumbar lordosis 3. Their ages were ranged from 20-35 years 4. Body Mass Index from 18-25 Kg/m² |
| Normal anterior pelvic tilt group | – | Other: pelvic tilt effect on balance, sensory integration and risk of fall1. patients with chronic low back pain or repeated non-specific back pain for more than three months. 2. Both sex with anterior pelvic tilt (5° and 13°) and normal lumbar lordosis 3. Their ages were ranged from 20-35 years 4. Body Mass Index from 18-25 Kg/m² |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Fifty patients with chronic low back pain or repeated non-specific back pain for more than three months and referred from a physician with anterior or posterior pelvic tilt angles according to the groups.
Key inclusion criteria (4 listed)
- 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 .
Key exclusion criteria (8 listed)
- Previous back surgery.
- Signs and symptoms of gross spinal instability.
- Radiological diagnosis of spondylolysis or spondylolisthesis.
- Acute low back pain.
- Disc prolapse or herniation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pelvic tilt effect on balance, sensory integration and risk of fallBIODEX balance system, Limits of stability test, Risk of Fall test, m-CTSIB test | Other | Normal anterior pelvic tilt group, Posterior pelvic tilt group |
Primary outcome
Biodex balance system Limits of stability test
Time frame: 10 minuets
A test measures dynamic postural stability in percentage
Biodex balance system m-CTSIB test
Time frame: 10 minuets
A test measures postural sway control to assess sensory integration.
Biodex balance system Fall risk test (FR)
Time frame: 10 minuets
A test to assess risk of fall according to mean age
Oswestry Disability Index (ODI)
Time frame: 10 minuets
An index to assess physical functioning in percentage.
2 secondary outcomes
The Global Posture System (GPS) 600
Time frame: 10 minuets
Body Mass Index (weight in kilograms, height in meters)
Time frame: 10 minuets
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
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.
Noha Abbas, MSc study chair
MTI 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 Biochemical Lesions Lumbar Region and Orthopedic Disorder of Spine, run by MTI 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 4 inclusion and 8 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 29 Mar 2021. 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?
Contact Noha Abbas, Bachelor (00201060742720, Noha.Abbas@pt.mti.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodex balance system Limits of stability test (time frame: 10 minuets). The study lists 4 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 29 Mar 2021.