NCT07206654

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2025

Completed
Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

1.7 years

First QC Date

September 26, 2025

Last Update Submit

September 26, 2025

Conditions

Keywords

GeriatricsVisual ImpairmentMusculoskeletal ComplaintsShoulder Girdle

Outcome Measures

Primary Outcomes (2)

  • Prevalence of Shoulder Girdle Pain

    Measure: Proportion of participants reporting shoulder girdle pain (Yes/No), assessed via standardized history and Visual Analog Scale (VAS).

    Singleassessmentatenrollment(Day1)

  • Prevalence of Shoulder Girdle Spasm and Stiffness

    Measure: Proportion of participants with clinically identified shoulder girdle spasm and stiffness (Yes/No).

    Singleassessmentatenrollment(Day1)

Secondary Outcomes (4)

  • Shoulder and Neck Range of Motion (ROM)

    Singleassessmentatenrollment(Day1)

  • Functional Status (ADL and IADL)

    Singleassessmentatenrollment(Day1)

  • Vision-Related Quality of Life

    Singleassessmentatenrollment(Day1)

  • Reading Performance

    Singleassessmentatenrollment(Day1)

Study Arms (2)

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)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Musculoskeletal complaints due to Parkinsonism.
  • Musculoskeletal complaints due to Osteoarthritis (OA) or Multiple Sclerosis (MS).
  • Inability to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni Suef University

Banī Suwayf, Beni Suweif Governorate, 11111, Egypt

Location

MeSH Terms

Conditions

Vision DisordersMacular DegenerationMusculoskeletal PainShoulder Pain

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsRetinal DegenerationRetinal DiseasesMuscular DiseasesMusculoskeletal DiseasesPainArthralgiaJoint Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof of Ophthalmology

Study Record Dates

First Submitted

September 26, 2025

First Posted

October 3, 2025

Study Start

September 1, 2023

Primary Completion

April 28, 2025

Study Completion

September 22, 2025

Last Updated

October 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations