Prevalence and Determinants of Shoulder Girdle Musculoskeletal Complaints in Geriatric Patients With Diminished Vision

Completed

• Conditions: Visual Impairment; Age-Related Macular Degeneration (AMD); Musculoskeletal Pain; Shoulder Pain; Geriatric Syndrome

• Registration Number: NCT07206654
• Lead Sponsor: Beni-Suef University

Brief 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 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 Timeline

• Study Start: 2023-09-01
• Primary Completion: 2025-04-28
• Status Verified: 2025-09
• Study Completion: 2025-09-22
• Study First Submitted: 2025-09-26
• Study First Submitted QC: 2025-09-26
• Last Update Submitted: 2025-09-26
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of Shoulder Girdle Pain	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	Singleassessmentatenrollment(Day1)	Measure: Proportion of participants with clinically identified shoulder girdle spasm and stiffness (Yes/No).

Secondary Outcome Measures

Name	Time	Method
Shoulder and Neck Range of Motion (ROM)	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.
Functional Status (ADL and IADL)	Singleassessmentatenrollment(Day1)	Scores on the Groningen Activity Restriction Scale (GARS) for ADL and a standardized IADL questionnaire. Higher scores indicate more restrictions.
Vision-Related Quality of Life	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
Reading Performance	Singleassessmentatenrollment(Day1)	Reading distance (in cm) and required magnification power (X) for near tasks.

Trial Locations

Locations (1)

Beni Suef University; 🇪🇬 Banī Suwayf, Beni Suweif Governorate, Egypt