Relationship Between Core Muscles Endurance and Saliba's Postural Classification System in Patients With Chronic Mechanical Low Back Pain

October 24, 2024 updated by: Sara Eltelbany, Cairo University
The aim of the study is to investigate the relationship between core muscles endurance and Saliba Postural Classification System in patients with chronic mechanical low back pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

chronic mechanical low back pain (CMLBP) is a significant health issue affecting 85-90% of the general and athletic population, causing a significant socioeconomic burden. This study aims to address functional deficits in patients with CMLBP, reducing the burden and improving care delivery and work performance. Core muscle dysfunction, particularly multifidus and transversus abdominus muscles, is found in patients with CMLBP. However, the relationship between posture, function, and pain is not established due to the absence of a standardized postural classification system. The proposed tests can help infer the stability and function of core muscles in patients with CMLBP, enabling researchers to develop effective treatment programs. This study may also benefit physical therapists by providing an evidence-based approach in assessment using a valid and reliable postural classification system. Future research may address the relationship between core muscle endurance and Saliba Postural Classification System in patients with CMLBP.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • out-patient clinic, faculty of physical therapy, Cairo university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study was a cross sectional, Observational, and correlation analysis

Description

Inclusion Criteria:

  1. Sixty male and female patients with CMLBP of more than 3 months duration
  2. Patients with body mass between 18-25
  3. Patients aged between 20-50 years old
  4. Moderate level of pain (4-6 on visual analogue scale)
  5. Minimal level of disability (0% to 20%) on Oswestry disability index as defined as "the patient can cope with most living activities. Usually, no treatment is indicated apart from advice on lifting, sitting, and exercise.

Exclusion Criteria:

Participants will be excluded if they did not meet the inclusion criteria mentioned above.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
assessment of pain intensity using visual analogue scale
Time Frame: at baseline
The visual analog scale (VAS) is a unidimensional measure of pain intensity, consisting of a horizontal line 10 cm long. It is anchored by "no pain" (score 0) and "worst imaginable pain" (score 10), with higher scores indicating greater pain intensity.
at baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
assessment of functional disability using cross-culturally adapted Arabic version of the Oswestry disability questionnaire
Time Frame: at baseline
For each item of the ODI, the participants will be asked to choose one answer that best defines his/her back function. Scores for each item will be tallied and the total score will be recorded. A total score from 0-20 to indicate "minimal disability", 20-40 to indicate "moderate disability," 40-60 to indicate "severe disability", 60-80 to indicate "housebound", and 80-100 to indicate "bedbound".
at baseline
assessment of mechanical stress points using vertical stress test to confirm the Saliba Postural Classification System
Time Frame: at baseline
The patient is positioned on a stool, chair, or table, with their forearms vertically and hovering. Force is directed towards the patient, ensuring they cannot move unless they buckle. The therapist's hands are placed on the patient's shoulders between the acromion and the first rib insertion. The test is graded 1-5, with 1-4 indicating dysfunction and 5 being efficient force translation to the support base. Inefficient responses cause spine side bends, backward bends, shears, or rotates.
at baseline
assessment of proper timing of core and global muscles in response to an external load using Elbow flexion test
Time Frame: at baseline
The patient's position is described as a 90-degree bend in elbows, with forearms supinated to a loose pack position, humerus perpendicular to the floor, and no shoulder adduction allowed. The therapist's position involves standing in front, applying resistance, positioning forearms perpendicular to the floor, and hovering with hand placement over the distal end of the forearm. The patient's stability response is observed, with efficient states activating core, rotator cuff, shoulder girdle, and global shoulder and arm muscles. Inefficient states involve giving in arms, shoulder girdle, and spine.
at baseline
assessment of trunk endurance using Trunk flexion test
Time Frame: at baseline
The patient is positioned in a sit-up position with their back against a 60-degree jig, knees and hips flexed 90 degrees, arms folded, and feet secured. The therapist pulls the jig back 10 cm and the patient holds an isometric posture for as long as possible. Failure is determined when any part of the back touches the jig. The patient's time holding the isometric posture is recorded, with a normal range of 1-2 minutes.
at baseline
assessment of back extensors (the erector spinae and the multifidus) endurance using trunk extension test
Time Frame: at baseline
The back extensors, erector spinae and multifidus, are tested with the upper body off the bench and secured, with the pelvis, knees, and hips secured. Participants hold the upper limbs across the chest, and failure occurs when the upper body drops below the horizontal position. The researcher records the time participants can hold the body straight.
at baseline
assessment of trunk side flexor endurance using side blank test
Time Frame: at baseline
The test start with patient lying on the side then the therapist will ask him to lift the body on the elbow, forearm, and feet stacked creating a straight line from head to toe. Same as prone plank time recorded as long as he could hold his body and hip off the floor. The researcher will record the time with a normal range of 1-2 minute
at baseline
assessment of trunk endurance using Prone plank test
Time Frame: at baseline
The test start with the patient in prone position and the therapist will ask the patient to support the upper body off the ground by the elbows and forearms, and to take the weight by the toes with the legs straight. The hip is lifted off the floor creating a straight line from head to toe. As soon as the patient is in the correct position, the therapist starts the stopwatch. The head should be facing towards the ground and not looking forwards. The test is over when the patient is unable to hold the back straight and the hip is lowered. The researcher will record the time of holding the body up, normal range is 1-2 minutes
at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Sara-008490

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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