Visual ImpairmentNCT07206654
Prevalence and Determinants of Shoulder Girdle Musculoskeletal Complaints in Geriatric Patients With Diminished Vision
An observational study of Visual Impairment and Age-Related Macular Degeneration (AMD), run by Beni-Suef University at 1 site in Egypt.
Trial summary
This case-control study aims to investigate the prevalence and determinants of shoulder girdle musculoskeletal complaints (pain, spasm, stiffness, range of motion impairments) in geriatric patients (aged 60+) with diminished vision (visual acuity <6/60) due to Age-related Macular Degeneration (AMD), compared to a… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Visual Impairment, Age-Related Macular Degeneration (AMD), Musculoskeletal Pain
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 22 Sep 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study enrolled a total of 100 Egyptian geriatric participants, recruited from the ophthalmology and geriatrics clinics of Helwan University Hospitals and Beni-Suef University Hospitals.
Who may be able to join
- Patients aged 60 years or older.
- For Case Group: Documented diagnosis of Age-Related Macular Degeneration (AMD) with visual impairment (visual acuity < 6/60).
- For Control Group: Normal vision, free from AMD as diagnosed by fundus examination and Snellen test.
Who cannot join
- Musculoskeletal complaints due to Parkinsonism.
- Musculoskeletal complaints due to Osteoarthritis (OA) or Multiple Sclerosis (MS).
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Case-Control Study on the Presence, Causes, and Frequencies of Shoulder Girdle Musculoskeletal Complaints in Geriatrics With Diminished Vision
This case-control study aims to investigate the prevalence and determinants of shoulder girdle musculoskeletal complaints (pain, spasm, stiffness, range of motion impairments) in geriatric patients (aged 60+) with diminished vision (visual acuity <6/60) due to Age-related Macular Degeneration (AMD), compared to a control group of age-matched elderly individuals with normal vision. The study will also assess the impact of these complaints on functional ability (Activities of Daily Living - ADL, Instrumental Activities of Daily Living - IADL) and quality of life using standardized questionnaires.
Read the detailed description
This is an observational, case-control study conducted at the ophthalmology and geriatrics departments of Helwan University Hospitals and Beni-Suef University Hospitals. A total of 100 participants will be enrolled: 50 cases with visually significant AMD and visual acuity <6/60, and 50 controls with normal vision. All participants will undergo a comprehensive assessment including: detailed history taking, full ophthalmic examination (visual acuity, slit-lamp, fundus examination), geriatric assessment (ADL, IADL), and a structured musculoskeletal evaluation of the shoulder girdle and neck. The musculoskeletal evaluation will include assessment of pain (Visual Analog Scale), spasm, stiffness, and active/passive range of motion measured by an orthopedic surgeon using standardized tools like a digital inclinometer. Health-related quality of life will be measured using the Arabic Version of the National Eye Institute Visual Function Questionnaire (ARB-VFQ-25). Statistical analysis will be performed to compare the two groups and identify correlating factors.
- Conditions
- Visual Impairment, Age-Related Macular Degeneration (AMD), Musculoskeletal Pain, Shoulder Pain, Geriatric Syndrome
- Keywords
- Geriatrics, Visual Impairment, Musculoskeletal Complaints, Shoulder Girdle
- Medical subject headings
- Vision Disorders, Macular Degeneration, Musculoskeletal Pain, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group/Cohort 1: Cases (Elderly with visual impairment <6/60 due to AMD) | Cases (Elderly with visual impairment <6/60 due to AMD) | |
| Group/Cohort 2: Controls (Elderly with normal vision, AMD-free) | Controls (Elderly with normal vision, AMD-free) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Shoulder Girdle Pain
Measure: Proportion of participants reporting shoulder girdle pain (Yes/No), assessed via standardized history and Visual Analog Scale (VAS).
Measured: Singleassessmentatenrollment(Day1)
Prevalence of Shoulder Girdle Spasm and Stiffness
Measure: Proportion of participants with clinically identified shoulder girdle spasm and stiffness (Yes/No).
Measured: Singleassessmentatenrollment(Day1)
Secondary outcomes (4)
Shoulder and Neck Range of Motion (ROM)
Measure: Degrees of active and passive ROM (Flexion, Abduction, Internal/External Rotation) measured with a digital inclinometer. Impairment is defined as a positive difference between unaffected and affected shoulder.
Measured: Singleassessmentatenrollment(Day1)
Functional Status (ADL and IADL)
Scores on the Groningen Activity Restriction Scale (GARS) for ADL and a standardized IADL questionnaire. Higher scores indicate more restrictions.
Measured: Singleassessmentatenrollment(Day1)
Vision-Related Quality of Life
Composite score from the Arabic Version of the National Eye Institute Visual Function Questionnaire (ARB-VFQ-25). Higher scores indicate better quality of life
Measured: Singleassessmentatenrollment(Day1)
Reading Performance
Reading distance (in cm) and required magnification power (X) for near tasks.
Measured: Singleassessmentatenrollment(Day1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Sep 2023
- Primary completion28 Apr 2025
- Study completion22 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual ImpairmentStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Collaborators
- Helwan University
- Responsible party
- Principal investigator, Mohamed Yasser Sayed Saif, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206654
- Sponsor's protocol ID
- FMBSUREC/11022024/El Fayoumi
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-Control Study on the Presence, Causes, and Frequencies of Shoulder Girdle Musculoskeletal Complaints in Geriatrics With Diminished Vision
- ClinicalTrials.gov ID
- NCT07206654
- Acronym / sponsor ID
- FMBSUREC/11022024/El Fayoumi
- Conditions
- Visual Impairment, Age-Related Macular Degeneration (AMD), Musculoskeletal Pain, Shoulder Pain, Geriatric Syndrome
- Keywords
- Geriatrics, Visual Impairment, Musculoskeletal Complaints, Shoulder Girdle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Collaborators
- Helwan University
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 22 Sep 2025 (actual)
- First posted
- 3 Oct 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 case-control study aims to investigate the prevalence and determinants of shoulder girdle musculoskeletal complaints (pain, spasm, stiffness, range of motion impairments) in geriatric patients (aged 60+) with diminished vision (visual acuity <6/60) due to Age-related Macular Degeneration (AMD), compared to a control group of age-matched elderly individuals with normal vision. The study will also assess the impact of these complaints on functional ability (Activities of Daily Living - ADL, Instrumental Activities of Daily Living - IADL) and quality of life using standardized questionnaires.
Detailed description
This is an observational, case-control study conducted at the ophthalmology and geriatrics departments of Helwan University Hospitals and Beni-Suef University Hospitals. A total of 100 participants will be enrolled: 50 cases with visually significant AMD and visual acuity <6/60, and 50 controls with normal vision. All participants will undergo a comprehensive assessment including: detailed history taking, full ophthalmic examination (visual acuity, slit-lamp, fundus examination), geriatric assessment (ADL, IADL), and a structured musculoskeletal evaluation of the shoulder girdle and neck. The musculoskeletal evaluation will include assessment of pain (Visual Analog Scale), spasm, stiffness, and active/passive range of motion measured by an orthopedic surgeon using standardized tools like a digital inclinometer. Health-related quality of life will be measured using the Arabic Version of the National Eye Institute Visual Function Questionnaire (ARB-VFQ-25). Statistical analysis will be performed to compare the two groups and identify correlating factors.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group/Cohort 1: Cases (Elderly with visual impairment <6/60 due to AMD) | – | –Cases (Elderly with visual impairment <6/60 due to AMD) |
| Group/Cohort 2: Controls (Elderly with normal vision, AMD-free) | – | –Controls (Elderly with normal vision, AMD-free) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study enrolled a total of 100 Egyptian geriatric participants, recruited from the ophthalmology and geriatrics clinics of Helwan University Hospitals and Beni-Suef University Hospitals.
Key inclusion criteria (3 listed)
- Patients aged 60 years or older.
- For Case Group: Documented diagnosis of Age-Related Macular Degeneration (AMD) with visual impairment (visual acuity < 6/60).
- For Control Group: Normal vision, free from AMD as diagnosed by fundus examination and Snellen test.
Key exclusion criteria (3 listed)
- Musculoskeletal complaints due to Parkinsonism.
- Musculoskeletal complaints due to Osteoarthritis (OA) or Multiple Sclerosis (MS).
- Inability to provide informed consent.
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
Prevalence of Shoulder Girdle Pain
Time frame: Singleassessmentatenrollment(Day1)
Measure: Proportion of participants reporting shoulder girdle pain (Yes/No), assessed via standardized history and Visual Analog Scale (VAS).
Prevalence of Shoulder Girdle Spasm and Stiffness
Time frame: Singleassessmentatenrollment(Day1)
Measure: Proportion of participants with clinically identified shoulder girdle spasm and stiffness (Yes/No).
4 secondary outcomes
Shoulder and Neck Range of Motion (ROM)
Time frame: Singleassessmentatenrollment(Day1)
Functional Status (ADL and IADL)
Time frame: Singleassessmentatenrollment(Day1)
Vision-Related Quality of Life
Time frame: Singleassessmentatenrollment(Day1)
Reading Performance
Time frame: Singleassessmentatenrollment(Day1)
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 Oct 2025.
- Individual participant dataSharing planned: No
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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 Visual Impairment and Age-Related Macular Degeneration (AMD), run by Beni-Suef 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 3 inclusion and 3 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 Oct 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?
Prevalence of Shoulder Girdle Pain (time frame: Singleassessmentatenrollment(Day1)). The study lists 2 primary outcomes in all. 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 3 Oct 2025.