Pseudoexfoliation Syndrome, Sarcopenia and Chronic Pain

NCT06121154 | Completed

• 1 other identifier: SarcoPEX
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: Pseudoexfoliation syndrome (PEX) is a systemic disease of connective tissue, it can also contribute to sarcopenia and chronic musculoskeletal pain with common pathways.

1. 1.First aim of this study was to investigate whether the rate of sarcopenia is higher in patients with PEX
2. 2.Second aim was to investigate the association between PEX, sarcopenia parameters and chronic musculoskeletal pain.

Conditions

Sarcopenia; Pseudoexfoliation Syndrome

Keywords

sarcopenia; pseudoexfoliation syndrome; chronic pain

Outcome Measures

Primary Outcomes (1)

• SARC-F

  The SARC-F scale has 5 questions which evaluate strength, assistance in ambulation, rising from a chair, stair climbing, and falls. The cut off point for predicting sarcopenia is score 4; "4 and more" means risk of sarcopenia.

  Baseline

Secondary Outcomes (4)

• Grip strength

  Baseline

• Visual analog scale

  Baseline

• The chair rise test

  Baseline

• Gait speed

  Baseline

Study Arms (2)

PEX-positive patients

The criteria to diagnose Pseudoexfoliation syndrome (PEX) were, after pupillary dilatation, the presence of white fluffy dandruff-like material on one or more anterior segment structures, including the pupillary margin, the anterior lens capsule, or the angle in biomicroscopic examination. The patients were divided into two groups: solely based on PEX-positive (n=48) and PEX-negative (n=48) status

Diagnostic Test: SARC-F questionnaire; Diagnostic Test: Gait speed; Diagnostic Test: The chair rise test; Diagnostic Test: Grip strength; Diagnostic Test: Visual analog scale

PEX-negative patients

The criteria to diagnose Pseudoexfoliation syndrome (PEX) were, after pupillary dilatation, the presence of white fluffy dandruff-like material on one or more anterior segment structures, including the pupillary margin, the anterior lens capsule, or the angle in biomicroscopic examination. The patients were divided into two groups: solely based on PEX-positive (n=48) and PEX-negative (n=48) status

Diagnostic Test: SARC-F questionnaire; Diagnostic Test: Gait speed; Diagnostic Test: The chair rise test; Diagnostic Test: Grip strength; Diagnostic Test: Visual analog scale

Interventions

SARC-F questionnaire DIAGNOSTIC_TEST

The SARC-F scale has 5 questions which evaluate strength, assistance in ambulation, rising from a chair, stair climbing, and falls. The cut off point for predicting sarcopenia is score 4; "4 and more" means risk of sarcopenia.

PEX-negative patients; PEX-positive patients

Gait speed DIAGNOSTIC_TEST

Low gait speed was defined as walking below than 0.8 meters per second.

PEX-negative patients; PEX-positive patients

The chair rise test DIAGNOSTIC_TEST

the chair rise test (measures the strength of leg muscles), it measures the time taken for 5 times of rising from the sitting position without using arms, and was defined as low when the time taken was more than 15 seconds

PEX-negative patients; PEX-positive patients

Grip strength DIAGNOSTIC_TEST

Grip strength was measured with a hand-held dynamometer (Baseline, White Plains, New York, USA), and the cut-off thresholds were 32 kg for males and 22 kg for females

PEX-negative patients; PEX-positive patients

Visual analog scale DIAGNOSTIC_TEST

The visual analogue scale (VAS) was used for measuring general body pain severity, which was assessed from 0 (no pain) to 10 (worst possible pain)

PEX-negative patients; PEX-positive patients

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This case-control study was conducted with 98 patients who admitted to Department of Physical Medicine and Rehabilitation Outpatient Clinic, Eskişehir Osmangazi University Hospital between March-August 2023.

You may qualify if:

• Being over 60 years
• Undergoing a detailed complete ophtalmic examination by an experienced physician within 1 month at the Department of Ophtalmology in the same university hospital.

You may not qualify if:

• having ophtalmic diseases that cause vision loss and reduce quality of life and mobility smoking, acute/subacute pain, amputation, infection, active arthritis, active cancer, having any protesis or surgery in lower extremities and low back, neurological disorders, malabsorption, weight loss, uncontrolled major systemic diseases, impaired cognitive function and being immobilised.

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskişehir Osmangazi University

Eskişehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sarcopenia; Exfoliation Syndrome; Chronic Pain

Interventions

Walking Speed; Hand Strength; Visual Analog Scale

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Iris Diseases; Uveal Diseases; Eye Diseases; Pain

Intervention Hierarchy (Ancestors)

Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Muscle Strength

Study Officials

• Fulya Bakılan, Assoc Prof

  Eskişehir Osmangazi University

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 7, 2023
• Study Start: March 30, 2023
• Primary Completion: August 15, 2023
• Study Completion: October 25, 2023
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)