Gender DifferencesNCT07018154
Gender Differences in Musculoskeletal Assessment Methods in Patients With Chronic Mechanical Low Back Pain
An observational study of Gender Differences and Musculoskeletal Assessment, run by Cairo University at 1 site in Egypt.
Trial summary
This study is an observational test-retest study designed to investigate the effect of gender on core strength, balance, spinal mobility, and hamstring flexibility in patients with chronic non-specific low back pain (NS-LBP). Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Gender Differences, Musculoskeletal Assessment, Chronic
- What is being tested?
- Musculoskeletal Assessment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 31 May 2025
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: The current study is an observational test-retest study designed to investigate the effect of gender on core strength, balance, spinal mobility, and hamstring flexibility in patients with chronic nonspecific low back pain (NS-LBP).
Who may be able to join
- Both sexes will be involved.
- Patients suffer from chronic NS-LBP for more than 3 months.
- Patients' age ranges from 18 to 40 years, and body mass index ranges from 18 to 25 kg/m2.
- Patients with sufficient cognitive abilities that enable them to understand and follow instructions.
Who cannot join
- History of spinal trauma or fractures.
- Osteoporotic patients.
- Patients using analgesics during the last 3 months.
- Pregnant or lactating females.
- Neurological musculoskeletal diseases that affect the lower back (eg, spondylosis, spondylolisthesis, disc injuries).
- Previous spinal surgery.
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- Posture deformities.
- Cauda equina symptoms related to the spine, including changes in bowel and bladder control.
- Signs of severe pathology (eg, malignancy, inflammatory disorders).
- Patients with severe psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
This study is an observational test-retest study designed to investigate the effect of gender on core strength, balance, spinal mobility, and hamstring flexibility in patients with chronic non-specific low back pain (NS-LBP).
Read the detailed description
Low back pain (LBP) is the primary contributor to years of disability. Individual features (age, physical fitness), psychosocial factors (stress, anxiety, and depression), and occupational factors (hard physical work, bending and twisting motions, and vibration) have all been linked to the development of LBP, which is thought to have a complex etiology.
- Conditions
- Gender Differences, Musculoskeletal Assessment, Chronic, Low Back Pain
- Being tested
- Musculoskeletal Assessment
- Medical subject headings
- Bronchiolitis Obliterans Syndrome, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musculoskeletal AssessmentOther
Patients underwent a musculoskeletal Assessment.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Female patients with chronic nonspecific low back pain (NS-LBP). Receives: Other: Musculoskeletal Assessment | |
| Group B | Male patients with chronic nonspecific low back pain (NS-LBP). Receives: Other: Musculoskeletal Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core strength
Measurement of core strength was done with the patient in the crooked lying position. Then, the cuff of the device was held under the lower back of the patient, and the patient was instructed to press against this cuff, tuck his abdomen, and hold the contraction.
Measured: 6 months post-procedure
Secondary outcomes (3)
Balance control
Romberg's test was used to assess static balance control. Each patient was tested in a single-leg stance with their eyes open on both a stable surface and then on an unstable surface. For the starting position, each patient stands on their dominant leg (determined by the football kicking test), with the unsupported leg in a neutral hip and 90-degree knee flexion position, and their arms crossed at chest level; the examiner observes this position for 60 seconds. In each test condition (SS and SUS), each patient was asked to maintain the position, and the duration for which they held the position was recorded.
Measured: 6 months post-procedure
Spinal mobility
The Mini-Mental State Examination (MMSE) was used to measure lumbar flexion and extension range of motion. The measurements were taken in a neutral standing position. A line connecting the two posterior superior iliac spines was drawn. Then, two points in the middle of the line and 15 cm above were marked. With lumbar flexion or extension, the distance between the two points was measured and subtracted from the 15 cm distance
Measured: 6 months post-procedure
Hamstring flexibility
To begin the hamstring flexibility test, the patient sits on the floor with both feet straight forward against a box. Both knees were pressed down to the floor. With the palms facing downwards, and the hands side by side, the subject stretched forward four times and held the position of maximum reach on the fourth count. The patient was asked to maintain the position for two counts. The most distant line touched by the fingertips of both hands was noted, and the distance was measured in cm.
Measured: 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start1 Sep 2024
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender DifferencesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boles Hanna Boles Melk, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018154
- Sponsor's protocol ID
- P.T.REC/012/004982
- Status last verified
- Jun 2025
- First submitted
- 31 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Differences in Musculoskeletal Assessment Methods in Patients With Chronic Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT07018154
- Acronym / sponsor ID
- P.T.REC/012/004982
- Conditions
- Gender Differences, Musculoskeletal Assessment, Chronic, Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 12 Jun 2025 (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 an observational test-retest study designed to investigate the effect of gender on core strength, balance, spinal mobility, and hamstring flexibility in patients with chronic non-specific low back pain (NS-LBP).
Detailed description
Low back pain (LBP) is the primary contributor to years of disability. Individual features (age, physical fitness), psychosocial factors (stress, anxiety, and depression), and occupational factors (hard physical work, bending and twisting motions, and vibration) have all been linked to the development of LBP, which is thought to have a complex etiology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Musculoskeletal AssessmentFemale patients with chronic nonspecific low back pain (NS-LBP). |
| Group B | – | Other: Musculoskeletal AssessmentMale patients with chronic nonspecific low back pain (NS-LBP). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The current study is an observational test-retest study designed to investigate the effect of gender on core strength, balance, spinal mobility, and hamstring flexibility in patients with chronic nonspecific low back pain (NS-LBP).
Key inclusion criteria (4 listed)
- Both sexes will be involved.
- Patients suffer from chronic NS-LBP for more than 3 months.
- Patients' age ranges from 18 to 40 years, and body mass index ranges from 18 to 25 kg/m2.
- Patients with sufficient cognitive abilities that enable them to understand and follow instructions.
Key exclusion criteria (10 listed)
- History of spinal trauma or fractures.
- Osteoporotic patients.
- Patients using analgesics during the last 3 months.
- Pregnant or lactating females.
- Neurological musculoskeletal diseases that affect the lower back (eg, spondylosis, spondylolisthesis, disc injuries).
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 |
|---|---|---|
| Musculoskeletal AssessmentPatients underwent a musculoskeletal Assessment. | Other | Group A, Group B |
Primary outcome
Core strength
Time frame: 6 months post-procedure
Measurement of core strength was done with the patient in the crooked lying position. Then, the cuff of the device was held under the lower back of the patient, and the patient was instructed to press against this cuff, tuck his abdomen, and hold the contraction.
3 secondary outcomes
Balance control
Time frame: 6 months post-procedure
Spinal mobility
Time frame: 6 months post-procedure
Hamstring flexibility
Time frame: 6 months post-procedure
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 12 Jun 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Gender Differences and Musculoskeletal Assessment, 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 10 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 12 Jun 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?
Core strength (time frame: 6 months post-procedure). 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 12 Jun 2025.