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Pseudoexfoliation Syndrome, Sarcopenia and Chronic Pain

A Possible Association Between Pseudoexfoliation Syndrome, Sarcopenia and Chronic Pain

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06121154
Enrollment
96
Registered
2023-11-07
Start date
2023-03-30
Completion date
2023-10-25
Last updated
2023-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia, Pseudoexfoliation Syndrome

Keywords

sarcopenia, pseudoexfoliation syndrome, chronic pain

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. First aim of this study was to investigate whether the rate of sarcopenia is higher in patients with PEX 2. 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).

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. 1. First aim of this study was to investigate whether the rate of sarcopenia is higher in patients with PEX 2. 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).

Interventions

DIAGNOSTIC_TESTGait speed

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

DIAGNOSTIC_TESTThe 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_TESTSARC-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_TESTGrip 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_TESTVisual 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)

Sponsors

Eskisehir Osmangazi University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
SARC-FBaselineThe 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

MeasureTime frameDescription
Grip strengthBaselineGrip 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 scaleBaselineThe 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 testBaselineIt 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 speedBaselineLow gait speed was defined as walking below than 0.8 meters per second.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026