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NCT Number: NCT07206654

Prevalence and Determinants of Shoulder Girdle Musculoskeletal Complaints in Geriatric Patients 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.

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Key information

Conditions

Visual Impairment Age-related Macular Degeneration (AMD) Arthralgia Eye Diseases Geriatric Syndrome Joint Diseases Macular Degeneration Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Sensation Disorders Shoulder Pain Signs and Symptoms Vision Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beni Suef University

Banī Suwayf, Beni Suweif Governorate, 11111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Musculoskeletal complaints due to Parkinsonism.

Musculoskeletal complaints due to Osteoarthritis (OA) or Multiple Sclerosis (MS).

Inability to provide informed consent.

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. Shoulder and Neck Range of Motion (ROM)

    Time frame: Singleassessmentatenrollment(Day1)

    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.

  2. Functional Status (ADL and IADL)

    Time frame: Singleassessmentatenrollment(Day1)

    Scores on the Groningen Activity Restriction Scale (GARS) for ADL and a standardized IADL questionnaire. Higher scores indicate more restrictions.

  3. Vision-Related Quality of Life

    Time frame: Singleassessmentatenrollment(Day1)

    Composite score from the Arabic Version of the National Eye Institute Visual Function Questionnaire (ARB-VFQ-25). Higher scores indicate better quality of life

  4. Reading Performance

    Time frame: Singleassessmentatenrollment(Day1)

    Reading distance (in cm) and required magnification power (X) for near tasks.

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Collaborators

  • Helwan University

Registry information

Official study title

A Case-Control Study on the Presence, Causes, and Frequencies of Shoulder Girdle Musculoskeletal Complaints in Geriatrics With Diminished Vision

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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