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Core MusclesNCT06660472

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

An observational study of Core Muscles and Endurance, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 50 years
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Nov 2023to 1 Jul 2024
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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: This study was a cross sectional, Observational, and correlation analysis

Who may be able to join

  • Sixty male and female patients with CMLBP of more than 3 months duration
  • Patients with body mass between 18-25
  • Patients aged between 20-50 years old
  • Moderate level of pain (4-6 on visual analogue scale)
  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • out-patient clinic, faculty of physical therapy, Cairo university

    Giza

Other trials in Egypt

About this study

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.

Read the 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.

Medical subject headings
Low Back Pain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. assessment of pain intensity using visual analogue scale

    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.

    Measured: at baseline

Secondary outcomes (7)
  1. assessment of functional disability using cross-culturally adapted Arabic version of the Oswestry disability questionnaire

    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".

    Measured: at baseline

  2. assessment of mechanical stress points using vertical stress test to confirm the Saliba Postural Classification System

    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.

    Measured: at baseline

  3. assessment of proper timing of core and global muscles in response to an external load using Elbow flexion test

    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.

    Measured: at baseline

  4. assessment of trunk endurance using Trunk flexion test

    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.

    Measured: at baseline

  5. assessment of back extensors (the erector spinae and the multifidus) endurance using trunk extension test

    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.

    Measured: at baseline

  6. assessment of trunk side flexor endurance using side blank test

    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

    Measured: at baseline

  7. assessment of trunk endurance using Prone plank test

    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

    Measured: at baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2024
  2. Study start1 Nov 2023
  3. Primary completion1 Mar 2024
  4. Study completion1 Jul 2024

Resources

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
Other
Time perspective
Cross-sectional
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06660472
Sponsor's protocol ID
Sara-008490
Status last verified
Oct 2024
First submitted
24 Oct 2024
Last updated
28 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Core Muscles and Endurance, run by Cairo 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 28 Oct 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

assessment of pain intensity using visual analogue scale (time frame: at baseline). 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 28 Oct 2024.

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