Chronic Low-back PainNCT06296667
Effect of Core Muscles Training On Patients With Chronic Mechanical Low Back Pain According To SALIBA'S Postural Classification System
A study testing core muscles training exercises in people with Chronic Low-back Pain, run by Cairo University at 1 site in Egypt.
Trial summary
This study is designed as a pre and post experimental study. The purposes of this study are to evaluate the effect of core muscles training in patients with chronic mechanical low back pain according to SALIBA'S postural classification system (SPCS) in terms of pain intensity, function, and core muscles endurance. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- core muscles training exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 1 Apr 2024
- Phase
- Interventional
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients referred with a diagnosis of CMLBP of at least 3 months.
- Age ranging from 20 to 55 years old.
- Both genders will be included.
- BMI(18.5-24.9).
Who cannot join
- Lumbar canal stenosis.
- History of vertebral fractures.
- patients with neurological deficits such as altered sensation.
- Spinal surgery or failed back surgery.
- cardiovascular/ pulmonary disorder
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed as a pre and post experimental study. The purposes of this study are to evaluate the effect of core muscles training in patients with chronic mechanical low back pain according to SALIBA'S postural classification system (SPCS) in terms of pain intensity, function, and core muscles endurance.
Read the detailed description
Male and female patients diagnosed with chronic mechanical low back pain will be referred to physical therapy department. Patients will then be screened based on the inclusion and exclusion criteria of the current study. They will be asked to sign the informed consent form. Then, participants will be assessed for the severity of pain, functional disability, and core endurance test at baseline and at the end of the treatment by the same physiotherapist.
In addition, participants will be instructed to stand in habitual posture while looking forward and will be photographed from sagittal plane wearing shorts(males) and a thin clothes(female). The photos will be used to subjectively classify the patients into one of the 6 postural classification groups (G1, G2, G3,G4, G5, G6). The Vertical compression test and elbow flexion test will be used to objectively confirm the classification.
Later, photos will be then entered by researcher to Kinovea software for more objective confirmation of the classification.
Then, Participants will be allocated purposive randomly to one of the six groups according to evaluation criteria(saliba's postural classification system).
Then, Patients in each postural category will receive a 4-week program of core muscles training.
Two tests will be used to further confirm the classification of patients' posture.
These tests are:
- Vertical compression test (VCT): Patient position: the patient will be asked to stand in a natural position and relax everything but the knees (so as not to buckle and collapse when pressure is applied) Therapist's position and manual contact: Standing side by side or stride position, therapist may be positioned on a stool, chair, or table. Therapist positions forearms vertical then hovers and place hands on the patient's shoulders, between the acromion and the first rib insertion. Therapist must ensure that all force is directed to patient and not allow movement in his or her body unless patient buckles. Therapist's action and verbal command: After instruction, apply gentle, sustained pressure vertically through the patient's trunk or pelvis. Gradually build the pressure from a grade of (1) which is at the point. Where the therapist feels the pressure of the patient's bony surfaces through the soft tissue covering the carpal ridge, to a (2) which is double the pressure of (1), and then to a (3) which is triplethe pressure of (1), and so on until full force is applied which would be a grade of (5). An efficient response is one in which the pressure applied by the therapist translates evenly to the base of support. In standing that would be to the arch of the foot, translating into the second ray. An efficient response is a springy end feel An inefficient response (failure) is noted when the pressure applied by the therapist causes the spine to side bend, backward bend, shear or rotate. In addition, an inefficient response is a hard end feel.
2-Elbow flexion test (EFT): Purpose: to test the proper timing of core and global muscles in response to an external load through the forearms and confirm findings of the CoreFirst Patient's position: In Standing, patient's elbows will be bent to 90 degrees, forearms supinated to loose-packed position and humerus is perpendicular to the floor, not flexed or extended and no substitution of shoulder adduction allowed to assist in stabilization. Therapist's position and manual contact: Therapist stands in front of patient, may be in squat position for resistance from below and therapist may also apply resistance from above. Therapist positions forearms perpendicular to floor then hovers. Hand placement is over the distal end of the forearm. Verbal command: "Don't let me straighten your arms". Once the command is given, the therapist gradually increases the downward resistance, being cautious NOT to pull forward while pushing or pulling down. Grading is 1-5, with "1" defined as the amount of pressure requires to feel the bones of your hands on the bones of the patient's forearms, and 2 = 2x1, 3 = 3x1, 4 = 4x1, and 5 - 5x1. When applying the resistance, the therapist asks the patient to note where the effort is and how hard it feels to maintain the position. The patient should note if the effort is in the cervical, shoulder girdle, thoracic spine, lumbar spine, or forearms. An efficient state is one in which the patient can maintain the elbow position through automatic activation of the core, rotator cuff, shoulder girdle, and global shoulder and arm muscles. The spine should remain stable, and the patient should maintain his balance. In an inefficient state, the patient will attempt to maintain the position with global muscles and will often give in the arms, shoulder girdle, and spine. The patient will frequently fall forward as the force is applied or tilt the upper body back to compensate for the load.
- Conditions
- Chronic Low-back Pain
- Being tested
- core muscles training exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
core muscles training exercisesOther
The sessions will be conducted three times per week for four weeks and each exercise will be performed two sets of 10 repetitions. For the static exercises, the final position will be held for 6 second. There will be a pause of 3 second between repetitions, and a 60 sec rest between each exercise. The exercise will be performed in three forms: abdominal bracing, dynamic stabilization, and advanced core strengthening.
| Study group | Role | What they receive |
|---|---|---|
| group1: vertical/ vertical | Experimental | participant posture: The thoracic block is vertically aligned over the pelvic block.The angle of the thoracic block is vertical in the sagittal plane allowing for the dome of the diaphragm to rest on top of the abdomen.Vertical force transfers through the musculoskeletal system through the mid-foot and into the standing surface causing no shifts in postural alignment. Receives: Other: core muscles training exercises |
| group 2: vertical/ posterior | Experimental | participant posture: The thoracic block is vertically aligned over the pelvic block but is posteriorly tipped in the sagittal plane.Vertical force leads to an accentuated extension in the thoracolumbar and lumbar regions with decreased ability to sustain vertical forces. Receives: Other: core muscles training exercises |
| group 3: posterior/ posterior | Experimental | participant posture: The thoracic block is aligned posterior to the pelvic block and is posteriorly tipped in the sagittal plane. Vertical force leads to an accentuated extension in the lower lumbar region with a forward shear of the pelvis and decreased ability to sustain vertical forces. Receives: Other: core muscles training exercises |
| group 4: posterior/ anterior | Experimental | participant posture: The thoracic block is aligned posterior to the pelvic block and is anteriorly tipped in the sagittal plane. Vertical force leads to a slight flexion in the thoracic and lumbar regions with a forward shear of the pelvis and decreased ability to sustain vertical force. Receives: Other: core muscles training exercises |
| group 5:anterior/ posterior | Experimental | participant posture: The thoracic block is aligned anterior to the pelvic block and is posteriorly tipped in the sagittal plane. Vertical force leads to extension in the mid and lower lumbar regions with a posterior shear of the pelvis and decreased ability to sustain vertical forces. Receives: Other: core muscles training exercises |
| group 6: anterior/ anterior | Experimental | participant posture: The thoracic block is aligned anterior to the pelvic block and is anteriorly tipped in the sagittal plane. Vertical force leads to an overall flexion of the trunk and decreased ability to sustain vertical forces Receives: Other: core muscles training exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity.
Pain intensity will be assessed using the visual analog scale (VAS). The VAS is a unidimensional measure of pain intensity. It is a continuous scale comprises of a horizontal line 10 cm in length. The scale is anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 10). A higher score indicates greater pain intensity
Measured: one month
function disability
Functional disability will be estimated using the cross-culturally adapted Arabic version of the Oswestry disability questionnaire.The score is calculated by the addition of the values assigned for each of the 10 individual questions and is used to categorize disability as: mild or no disability (0- 20%); moderate disability (21%-40%); severe disability (41% to 60%); incapacity (61% to 80%); restricted to bed (81% to 100%).
Measured: one month
core muscles endurance
The researcher will conduct a series of core stability tests before and after the core training program. The following core tests will be used: trunk flexion test (McGill's test) , Trunk extension (Sorenson Test, Right Side plank test,left side plank and prone plank test. We will record the time (in seconds) the patient can hold the isometric posture, with a normal range of 1-2 minutes
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 May 2023
- Primary completion15 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Saleh Elemam Yassin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296667
- Sponsor's protocol ID
- P.T.REC/012/003644
- Status last verified
- Jul 2025
- First submitted
- 27 Feb 2024
- Last updated
- 3 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdelkader NA, Soliman ES, Soliman MO, Elemam RS, Abdelmegeed MA. Impact of core strengthening on chronic mechanical low back pain: a clinical trial based on Saliba's postural classification. Eur Spine J. 2026 May;35(5):2924-2933. doi: 10.1007/s00586-025-09693-0. Epub 2026 Jan 22.
PubMed 41571933
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Core Muscles Training On Patients With Chronic Mechanical Low Back Pain According To SALIBA'S Postural Classification System
- ClinicalTrials.gov ID
- NCT06296667
- Acronym / sponsor ID
- P.T.REC/012/003644
- Conditions
- Chronic Low-back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 6 Mar 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.
This study is designed as a pre and post experimental study. The purposes of this study are to evaluate the effect of core muscles training in patients with chronic mechanical low back pain according to SALIBA'S postural classification system (SPCS) in terms of pain intensity, function, and core muscles endurance.
Detailed description
Male and female patients diagnosed with chronic mechanical low back pain will be referred to physical therapy department. Patients will then be screened based on the inclusion and exclusion criteria of the current study. They will be asked to sign the informed consent form. Then, participants will be assessed for the severity of pain, functional disability, and core endurance test at baseline and at the end of the treatment by the same physiotherapist.
In addition, participants will be instructed to stand in habitual posture while looking forward and will be photographed from sagittal plane wearing shorts(males) and a thin clothes(female). The photos will be used to subjectively classify the patients into one of the 6 postural classification groups (G1, G2, G3,G4, G5, G6). The Vertical compression test and elbow flexion test will be used to objectively confirm the classification.
Later, photos will be then entered by researcher to Kinovea software for more objective confirmation of the classification.
Then, Participants will be allocated purposive randomly to one of the six groups according to evaluation criteria(saliba's postural classification system).
Then, Patients in each postural category will receive a 4-week program of core muscles training.
Two tests will be used to further confirm the classification of patients' posture.
These tests are:
- Vertical compression test (VCT): Patient position: the patient will be asked to stand in a natural position and relax everything but the knees (so as not to buckle and collapse when pressure is applied) Therapist's position and manual contact: Standing side by side or stride position, therapist may be positioned on a stool, chair, or table. Therapist positions forearms vertical then hovers and place hands on the patient's shoulders, between the acromion and the first rib insertion. Therapist must ensure that all force is directed to patient and not allow movement in his or her body unless patient buckles. Therapist's action and verbal command: After instruction, apply gentle, sustained pressure vertically through the patient's trunk or pelvis. Gradually build the pressure from a grade of (1) which is at the point. Where the therapist feels the pressure of the patient's bony surfaces through the soft tissue covering the carpal ridge, to a (2) which is double the pressure of (1), and then to a (3) which is triplethe pressure of (1), and so on until full force is applied which would be a grade of (5). An efficient response is one in which the pressure applied by the therapist translates evenly to the base of support. In standing that would be to the arch of the foot, translating into the second ray. An efficient response is a springy end feel An inefficient response (failure) is noted when the pressure applied by the therapist causes the spine to side bend, backward bend, shear or rotate. In addition, an inefficient response is a hard end feel.
2-Elbow flexion test (EFT): Purpose: to test the proper timing of core and global muscles in response to an external load through the forearms and confirm findings of the CoreFirst Patient's position: In Standing, patient's elbows will be bent to 90 degrees, forearms supinated to loose-packed position and humerus is perpendicular to the floor, not flexed or extended and no substitution of shoulder adduction allowed to assist in stabilization. Therapist's position and manual contact: Therapist stands in front of patient, may be in squat position for resistance from below and therapist may also apply resistance from above. Therapist positions forearms perpendicular to floor then hovers. Hand placement is over the distal end of the forearm. Verbal command: "Don't let me straighten your arms". Once the command is given, the therapist gradually increases the downward resistance, being cautious NOT to pull forward while pushing or pulling down. Grading is 1-5, with "1" defined as the amount of pressure requires to feel the bones of your hands on the bones of the patient's forearms, and 2 = 2x1, 3 = 3x1, 4 = 4x1, and 5 - 5x1. When applying the resistance, the therapist asks the patient to note where the effort is and how hard it feels to maintain the position. The patient should note if the effort is in the cervical, shoulder girdle, thoracic spine, lumbar spine, or forearms. An efficient state is one in which the patient can maintain the elbow position through automatic activation of the core, rotator cuff, shoulder girdle, and global shoulder and arm muscles. The spine should remain stable, and the patient should maintain his balance. In an inefficient state, the patient will attempt to maintain the position with global muscles and will often give in the arms, shoulder girdle, and spine. The patient will frequently fall forward as the force is applied or tilt the upper body back to compensate for the load.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| group1: vertical/ vertical | Experimental | Other: core muscles training exercisesparticipant posture: The thoracic block is vertically aligned over the pelvic block.The angle of the thoracic block is vertical in the sagittal plane allowing for the dome of the diaphragm to rest on top of the abdomen.Vertical force transfers through the musculoskeletal system through the mid-foot and into the standing surface causing no shifts in postural alignment. |
| group 2: vertical/ posterior | Experimental | Other: core muscles training exercisesparticipant posture: The thoracic block is vertically aligned over the pelvic block but is posteriorly tipped in the sagittal plane.Vertical force leads to an accentuated extension in the thoracolumbar and lumbar regions with decreased ability to sustain vertical forces. |
| group 3: posterior/ posterior | Experimental | Other: core muscles training exercisesparticipant posture: The thoracic block is aligned posterior to the pelvic block and is posteriorly tipped in the sagittal plane. Vertical force leads to an accentuated extension in the lower lumbar region with a forward shear of the pelvis and decreased ability to sustain vertical forces. |
| group 4: posterior/ anterior | Experimental | Other: core muscles training exercisesparticipant posture: The thoracic block is aligned posterior to the pelvic block and is anteriorly tipped in the sagittal plane. Vertical force leads to a slight flexion in the thoracic and lumbar regions with a forward shear of the pelvis and decreased ability to sustain vertical force. |
| group 5:anterior/ posterior | Experimental | Other: core muscles training exercisesparticipant posture: The thoracic block is aligned anterior to the pelvic block and is posteriorly tipped in the sagittal plane. Vertical force leads to extension in the mid and lower lumbar regions with a posterior shear of the pelvis and decreased ability to sustain vertical forces. |
| group 6: anterior/ anterior | Experimental | Other: core muscles training exercisesparticipant posture: The thoracic block is aligned anterior to the pelvic block and is anteriorly tipped in the sagittal plane. Vertical force leads to an overall flexion of the trunk and decreased ability to sustain vertical forces |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients referred with a diagnosis of CMLBP of at least 3 months.
Key exclusion criteria (5 listed)
- Lumbar canal stenosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| core muscles training exercisesThe sessions will be conducted three times per week for four weeks and each exercise will be performed two sets of 10 repetitions. For the static exercises, the final position will be held for 6 second. There will be a pause of 3 second between repetitions, and a 60 sec rest between each exercise. The exercise will be performed in three forms: abdominal bracing, dynamic stabilization, and advanced core strengthening. | Other | group 2: vertical/ posterior, group 3: posterior/ posterior, group 4: posterior/ anterior, group 5:anterior/ posterior, group 6: anterior/ anterior, group1: vertical/ vertical |
Primary outcome
pain intensity.
Time frame: one month
Pain intensity will be assessed using the visual analog scale (VAS). The VAS is a unidimensional measure of pain intensity. It is a continuous scale comprises of a horizontal line 10 cm in length. The scale is anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 10). A higher score indicates greater pain intensity
function disability
Time frame: one month
Functional disability will be estimated using the cross-culturally adapted Arabic version of the Oswestry disability questionnaire.The score is calculated by the addition of the values assigned for each of the 10 individual questions and is used to categorize disability as: mild or no disability (0- 20%); moderate disability (21%-40%); severe disability (41% to 60%); incapacity (61% to 80%); restricted to bed (81% to 100%).
core muscles endurance
Time frame: one month
The researcher will conduct a series of core stability tests before and after the core training program. The following core tests will be used: trunk flexion test (McGill's test) , Trunk extension (Sorenson Test, Right Side plank test,left side plank and prone plank test. We will record the time (in seconds) the patient can hold the isometric posture, with a normal range of 1-2 minutes
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 3 Aug 2025.
- Derived from this study: PubMed 41571933Abdelkader NA, Soliman ES, Soliman MO, Elemam RS, Abdelmegeed MA. Impact of core strengthening on chronic mechanical low back pain: a clinical trial based on Saliba's postural classification. Eur Spine J. 2026 May;35(5):2924-2933. doi: 10.1007/s00586-025-09693-0. Epub 2026 Jan 22.
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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?
A study testing core muscles training exercises in people with Chronic Low-back Pain, 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 4 inclusion and 5 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 3 Aug 2025. 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?
pain intensity. (time frame: one month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06296667, which also lists 1 linked publication.
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 3 Aug 2025.