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.
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
- Conditions the study is for
- Core Muscles, Endurance, Saliba's Postural Classification System
- 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
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.
- Conditions
- Core Muscles, Endurance, Saliba's Postural Classification System, Low Back Pain, Mechanical
- Medical subject headings
- Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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.
- First posted28 Oct 2024
- Study start1 Nov 2023
- Primary completion1 Mar 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Core MusclesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Eltelbany, Cairo University
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Core Muscles Endurance and Saliba's Postural Classification System in Patients With Chronic Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT06660472
- Acronym / sponsor ID
- Sara-008490
- Conditions
- Core Muscles, Endurance, Saliba's Postural Classification System, Low Back Pain, Mechanical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study was a cross sectional, Observational, and correlation analysis
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants will be excluded if they did not meet the inclusion criteria mentioned above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
assessment of functional disability using cross-culturally adapted Arabic version of the Oswestry disability questionnaire
Time frame: at baseline
assessment of mechanical stress points using vertical stress test to confirm the Saliba Postural Classification System
Time frame: 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
assessment of trunk endurance using Trunk flexion test
Time frame: at baseline
assessment of back extensors (the erector spinae and the multifidus) endurance using trunk extension test
Time frame: at baseline
assessment of trunk side flexor endurance using side blank test
Time frame: at baseline
assessment of trunk endurance using Prone plank test
Time frame: at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.