Pseudoexfoliation Syndrome, Sarcopenia and Chronic Pain

Sponsor

Eskisehir Osmangazi University (Other)

Overall Status

Completed

CT.gov ID

NCT06121154

Collaborator

(none)

Enrollment

Location

6.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

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

Methods: A total of 96-patients were enrolled in this study and divided into two groups:

PEX-positive (n=48) and PEX-negative (n=48) patients. The variables: the demographic data, sarcopenia parameters (SARC-F-questionnaire, hand-grip strength, chair-rise test, gait speed) and pain parameters (having any chronic musculoskeletal pain, pain regions and visual analogue scale-pain).

Condition or Disease	Intervention/Treatment	Phase
Sarcopenia Pseudoexfoliation Syndrome	Diagnostic Test: SARC-F questionnaire Diagnostic Test: Gait speed Diagnostic Test: The chair rise test Diagnostic Test: Grip strength Diagnostic Test: Visual analog scale

Detailed Description

Sarcopenia is defined as a decreased muscle mass, muscle strength and muscle function, which leads to lower physical performance, disability and quality of life. Pseudoexfoliation syndrome (PEX) is an age-related, genetic and systemic disease characterized by the accumulation of abnormal extracellular fibrillar material in many ocular and extraocular tissues Aim: Pseudoexfoliation syndrome (PEX) is a systemic disease of connective tissue, it can also contribute to sarcopenia and chronic musculoskeletal pain with common pathways.

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

Methods: A total of 96-patients were enrolled in this study and divided into two groups according to having pseudoexfoliation material in ocular tissues: PEX-positive (n=48) and PEX-negative (n=48) patients. The variables: the demographic data, sarcopenia parameters (SARC-F-questionnaire, hand-grip strength, chair-rise test, gait speed) and pain parameters (having any chronic musculoskeletal pain, pain regions and visual analogue scale-pain).

Study Design

Study Type:

Observational

Actual Enrollment :

96 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

A Possible Association Between Pseudoexfoliation Syndrome, Sarcopenia and Chronic Pain

Actual Study Start Date :

Mar 30, 2023

Actual Primary Completion Date :

Aug 15, 2023

Actual Study Completion Date :

Oct 25, 2023

Arms and Interventions

Arm	Intervention/Treatment
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 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. Diagnostic Test: Gait speed Low gait speed was defined as walking below than 0.8 meters per second. Diagnostic Test: The chair rise 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 Diagnostic Test: Grip strength 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 Diagnostic Test: Visual analog scale 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 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 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. Diagnostic Test: Gait speed Low gait speed was defined as walking below than 0.8 meters per second. Diagnostic Test: The chair rise 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 Diagnostic Test: Grip strength 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 Diagnostic Test: Visual analog scale 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)

Arm

Intervention/Treatment

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

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.

Diagnostic Test: Gait speed

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

Diagnostic Test: The chair rise 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

Diagnostic Test: Grip strength

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

Diagnostic Test: Visual analog scale

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

Diagnostic Test: SARC-F questionnaire

Diagnostic Test: Gait speed

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

Diagnostic Test: The chair rise test

Diagnostic Test: Grip strength

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

Diagnostic Test: Visual analog scale

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)

Outcome Measures

Primary Outcome Measures

SARC-F [Baseline]
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.

Secondary Outcome Measures

Grip strength [Baseline]
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
Visual analog scale [Baseline]
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)
The chair rise test [Baseline]
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
Gait speed [Baseline]
Low gait speed was defined as walking below than 0.8 meters per second.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.