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Completed

NCT Number: NCT06121154

Pseudoexfoliation Syndrome, Sarcopenia and Chronic Pain

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).

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Key information

Conditions

Sarcopenia Atrophy Chronic Pain Exfoliation Syndrome Eye Diseases Iris Diseases Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pseudoexfoliation Syndrome Signs and Symptoms Uveal Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eskişehir Osmangazi University

Eskişehir, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Gait speed

Diagnostic Test

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

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

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

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)

Primary outcomes

  1. SARC-F

    Time frame: 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 outcomes

  1. Grip strength

    Time frame: 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

  2. Visual analog scale

    Time frame: 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)

  3. The chair rise test

    Time frame: 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

  4. Gait speed

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

A Possible Association Between Pseudoexfoliation Syndrome, Sarcopenia and Chronic Pain

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 7, 2023
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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