Prediction of Back Disability in Adults With Low Back Pain

Prediction of Back Disability Using Clinical, Functional, and Bio-mechanical Variables in Adults With Low Back Pain

Low back pain (LBP) is one of the most enormous and challenging disorders. LBP represents a leading cause of disability worldwide. A number of variables (clinical, functional and mechanical) may predispose to back disability. Clinical variables such as pain may affect the patient ability to move and also may result in muscle spasm that led to more pain and movement restriction. Further, functional capabilities may affect the patient and when reduced may lead to disability. Moreover, biomechanical factors such as abnormal posture creates abnormal stress and strain in many spinal structures which are considered predisposing factors for pain and disability.

There is a gab of evidence to examine the relationships between those variables and to predict disability in patients with chronic nonspecific low back pain using various variables.

Study Overview

• Status: Enrolling by invitation
• Conditions: Low Back Pain
• Intervention / Treatment: Diagnostic test: sorensen test for back endurance; Diagnostic test: 6 minute walk test; Diagnostic test: c7-s1 SVA

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Egypt
  • Benha
    • Cairo, Benha, Egypt, 13518
      • Benha University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

100 subjects will be recruited from the university A local advertisement sent via e-mail to the university's postgraduate students and administrative staff

Description

Inclusion Criteria:

- age between 20 and 40 years, either sex, and symptoms lasting longer than three months, which imply chronicity

Exclusion Criteria:

• Pregnancy, Spinal pathologies or surgery, or any other deformities or visual or auditory issues, as well as ongoing physical or medical treatment for LBP

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
normal; normal persons	Diagnostic test: sorensen test for back endurance; • Biering-Sorensen test will be utilized to gauge the trunk extensor muscles' isometric endurance. The patient will be lying on a treatment couch, prone. The top half of the body will be permitted to rest on a chair prior to the test starting. The patient will be told to elevate their upper trunks off of the chair at the start of the test. the examiner determined how long the individual could hold this position.; Diagnostic test: 6 minute walk test; It gauges how far a person can go while walking for a total of six minutes on a level, hard surface. Cones will be used to mark turns at the start and end of the 30-meter border and every three meters throughout the corridor or walkway that was utilized for the test. The patient's objective is to cover the most distance in six minutes at a reasonable pace. It gauges how far a person can go while walking for a total of six minutes on a level, hard surface. Cones will be used to mark turns at the start and end of the 30-meter border and every three meters throughout the corridor or walkway that was utilized for the test. The patient's objective is to cover the most distance in six minutes at a reasonable pace.; Diagnostic test: c7-s1 SVA; Subjects will obtain standardized lateral views radiographs in a neutral standing position for the whole spine. The C7- S1 SVA will be measured as the distance from the plumb line dropped from the center of the C7 vertebral body to the most posterior edge of the upper sacral endplate surface.
low back pain; patients with low back pain	Diagnostic test: sorensen test for back endurance; • Biering-Sorensen test will be utilized to gauge the trunk extensor muscles' isometric endurance. The patient will be lying on a treatment couch, prone. The top half of the body will be permitted to rest on a chair prior to the test starting. The patient will be told to elevate their upper trunks off of the chair at the start of the test. the examiner determined how long the individual could hold this position.; Diagnostic test: 6 minute walk test; It gauges how far a person can go while walking for a total of six minutes on a level, hard surface. Cones will be used to mark turns at the start and end of the 30-meter border and every three meters throughout the corridor or walkway that was utilized for the test. The patient's objective is to cover the most distance in six minutes at a reasonable pace. It gauges how far a person can go while walking for a total of six minutes on a level, hard surface. Cones will be used to mark turns at the start and end of the 30-meter border and every three meters throughout the corridor or walkway that was utilized for the test. The patient's objective is to cover the most distance in six minutes at a reasonable pace.; Diagnostic test: c7-s1 SVA; Subjects will obtain standardized lateral views radiographs in a neutral standing position for the whole spine. The C7- S1 SVA will be measured as the distance from the plumb line dropped from the center of the C7 vertebral body to the most posterior edge of the upper sacral endplate surface.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
back disability using oswestry disability index	oswestry disability index has been designed to give us information as to how your back pain has affected your ability to manage everyday life. For each question, there is a possible 5 points; 0 for the first answer, 1 for the second answer, etc. Add up the total for the 10 questions and rate them on the scale at right.. 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50 Completely disabled	1 month
back pain intensity using visual analogue scale	visual analogue scale (VAS) is one of the pain rating scales used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
back functional ability using back performance scale	Back performance scale (BPS) has been found to reflect important aspects of physical functioning. It consists of Sock Test, the Pick-up Test, the Roll-up Test, the Fingertip-to-Floor Test, and the Lift Test. For each test a score of 0 was considered a good performance with no signs of activity limitation, a score of 1 was considered a somewhat limited performance, a score of 2 was considered a rather distinct limitation of performance, and a score of 3 was considered a substantially limited performance, if performed at all. The BPS sum score is calculated by adding the individual scores of the 5 tests ranging from 0 to 15.	1 month

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Principal Investigator: Aliaa M Elabd, Benha University

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2023
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): January 15, 2024

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 15, 2023
• First Posted (Actual): January 2, 2024

Study Record Updates

• Last Update Posted (Actual): January 2, 2024
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: posture
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: PT.BU.EC.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: will be available up on reasonable request
• IPD Sharing Time Frame: up on completion
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No