NCT04820816

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2021

Completed
Last Updated

March 29, 2021

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

March 20, 2021

Last Update Submit

March 26, 2021

Conditions

Keywords

pelvic tiltsensory integrationbalanceback painbiodex

Outcome Measures

Primary Outcomes (4)

  • Biodex balance system Limits of stability test

    A test measures dynamic postural stability in percentage

    10 minuets

  • Biodex balance system m-CTSIB test

    A test measures postural sway control to assess sensory integration.

    10 minuets

  • Biodex balance system Fall risk test (FR)

    A test to assess risk of fall according to mean age

    10 minuets

  • Oswestry Disability Index (ODI)

    An index to assess physical functioning in percentage.

    10 minuets

Secondary Outcomes (2)

  • The Global Posture System (GPS) 600

    10 minuets

  • Body Mass Index (weight in kilograms, height in meters)

    10 minuets

Study Arms (2)

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

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

Other: pelvic tilt effect on balance, sensory integration and risk of fall

Interventions

BIODEX balance system, Limits of stability test, Risk of Fall test, m-CTSIB test

Normal anterior pelvic tilt groupPosterior pelvic tilt group

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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 .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Noha Abbas Abdelaziz Ali

Cairo, 1069, Egypt

RECRUITING

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Noha Abbas, MSc

    MTI University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 20, 2021

First Posted

March 29, 2021

Study Start

September 1, 2020

Primary Completion

April 1, 2021

Study Completion

April 15, 2021

Last Updated

March 29, 2021

Record last verified: 2021-03

Locations