NCT06186674

Brief Summary

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.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

December 12, 2023

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 2, 2024

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

18 days

First QC Date

December 7, 2023

Last Update Submit

December 15, 2023

Conditions

Keywords

posture

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • back functional ability using back performance scale

    1 month

Study Arms (2)

normal

normal persons

Diagnostic Test: sorensen test for back enduranceDiagnostic Test: 6 minute walk testDiagnostic Test: c7-s1 SVA

low back pain

patients with low back pain

Diagnostic Test: sorensen test for back enduranceDiagnostic Test: 6 minute walk testDiagnostic Test: c7-s1 SVA

Interventions

• 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.

low back painnormal
6 minute walk testDIAGNOSTIC_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.

low back painnormal
c7-s1 SVADIAGNOSTIC_TEST

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 painnormal

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha University

Cairo, Benha, 13518, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Walk Test

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TestHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Aliaa M Elabd

    Benha University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer, basic science department, faculty of physical therapy, benha university

Study Record Dates

First Submitted

December 7, 2023

First Posted

January 2, 2024

Study Start

December 12, 2023

Primary Completion

December 30, 2023

Study Completion

January 15, 2024

Last Updated

January 2, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

will be available up on reasonable request

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
up on completion

Locations