Low Back PainNCT07170501
Postural Control as a Predictor of Disability, Fall-Related Fear, and Social Participation in Elderly Women With Non-Specific Low Back Pain
An observational study of Low Back Pain and FALS, run by Cairo University at 1 site in Egypt.
Trial summary
Non-specific low back pain (NSLBP) is prevalent among elderly women and is often associated with impaired postural control, increased fear of falling, and reduced community participation. Read more about this study
- Who is it for?
- Ages 55 to 65 years, women only
- Conditions the study is for
- Low Back Pain, FALS
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 25 May 2025to 3 Jul 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 55 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: A total of 70 female participants aged between 55 and 65 years diagnosed with non-specific low back pain will be recruited for this study. All participants will be community-dwelling elderly women with adequate cognitive capacity, confirmed by a Mini-Mental State Examination (MMSE) score of 24 or above, to ensure reliable completion of assessment tools.
Who may be able to join
- Inclusion criteria include independent ambulation with or without assistive devices and a clinical diagnosis of non-specific low back pain persisting for at least three months.
Who cannot join
- Participants presenting with specific low back pain due to identifiable organic or pathological causes-such as herniated discs, spinal infections, fractures, tumors, inflammatory arthropathies, or neurological disorders affecting balance or gait-will be excluded to maintain sample homogeneity. Additional exclusion criteria include recent lower limb orthopedic surgery (within the past six months), uncontrolled cardiovascular or metabolic diseases, uncorrected visual or vestibular impairments, and severe cognitive impairment (MMSE < 24).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postural Control as a Predictor of Disability, Fall-Related Fear, and Social Participation in Elderly Women With Non-Specific Low Back Pain: A Cross-Sectional Study
Non-specific low back pain (NSLBP) is prevalent among elderly women and is often associated with impaired postural control, increased fear of falling, and reduced community participation. Understanding the interplay between these factors is essential for effective rehabilitation and fall prevention strategies in this vulnerable population.
Read the detailed description
This cross-sectional study aims to investigate
- the relationship between postural control and its predictive value for fear of falling, disability as measured by the Oswestry Disability Index (ODI), and community integration in elderly women with NSLBP.
- test whether postural control is a predictor for disability, fall-related fear and social engagement or not.
- Conditions
- Low Back Pain, FALS
- Keywords
- Postural Control; Disability; Fall-Related fear; Social Participation; Elderly Women ;Non-Specific Low Back Pain
- Medical subject headings
- Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
balance assessed by BBS
Measured: three months
Secondary outcomes (3)
disabilty assessed by ODI
Measured: three months
Fall-related fear
Measured: three months
community integration
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start25 May 2025
- Primary completion30 Jun 2025
- Study completion3 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azza Mohammed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170501
- Sponsor's protocol ID
- P.T.REC/012/005928
- Other IDs
- faculty of physical therapy ca
- Status last verified
- Sep 2025
- First submitted
- 19 May 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: i did not decide
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postural Control as a Predictor of Disability, Fall-Related Fear, and Social Participation in Elderly Women With Non-Specific Low Back Pain: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07170501
- Acronym / sponsor ID
- P.T.REC/012/005928
- Conditions
- Low Back Pain, FALS
- Keywords
- Postural Control; Disability; Fall-Related fear; Social Participation; Elderly Women ;Non-Specific Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 May 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 3 Jul 2025 (actual)
- First posted
- 12 Sep 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.
Non-specific low back pain (NSLBP) is prevalent among elderly women and is often associated with impaired postural control, increased fear of falling, and reduced community participation. Understanding the interplay between these factors is essential for effective rehabilitation and fall prevention strategies in this vulnerable population.
Detailed description
This cross-sectional study aims to investigate
- the relationship between postural control and its predictive value for fear of falling, disability as measured by the Oswestry Disability Index (ODI), and community integration in elderly women with NSLBP.
- test whether postural control is a predictor for disability, fall-related fear and social engagement or not.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 55 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 70 female participants aged between 55 and 65 years diagnosed with non-specific low back pain will be recruited for this study. All participants will be community-dwelling elderly women with adequate cognitive capacity, confirmed by a Mini-Mental State Examination (MMSE) score of 24 or above, to ensure reliable completion of assessment tools.
Key inclusion criteria (1 listed)
- Inclusion criteria include independent ambulation with or without assistive devices and a clinical diagnosis of non-specific low back pain persisting for at least three months.
Key exclusion criteria (1 listed)
- Participants presenting with specific low back pain due to identifiable organic or pathological causes-such as herniated discs, spinal infections, fractures, tumors, inflammatory arthropathies, or neurological disorders affecting balance or gait-will be excluded to maintain sample homogeneity. Additional exclusion criteria include recent lower limb orthopedic surgery (within the past six months), uncontrolled cardiovascular or metabolic diseases, uncorrected visual or vestibular impairments, and severe cognitive impairment (MMSE < 24).
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
balance assessed by BBS
Time frame: three months
3 secondary outcomes
disabilty assessed by ODI
Time frame: three months
Fall-related fear
Time frame: three months
community integration
Time frame: three months
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 Sep 2025.
- Individual participant dataSharing planned: Undecided. i did not decide
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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 Low Back Pain and FALS, 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 1 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 12 Sep 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?
balance assessed by BBS (time frame: three months). 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 Sep 2025.