Pseudoexfoliation Syndrome, Sarcopenia and Chronic Pain

A Possible Association Between 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).

Study Overview

• Status: Completed
• Conditions: Sarcopenia; Pseudoexfoliation Syndrome
• Intervention / Treatment: 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.

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).

• Study Type: Observational
• Enrollment (Actual): 96

Contacts and Locations

Study Locations

• Turkey
  • Eskişehir, Turkey
    • Eskisehir Osmangazi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline
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)	Baseline
The chair rise test	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	Baseline
Gait speed	Low gait speed was defined as walking below than 0.8 meters per second.	Baseline

Collaborators and Investigators

• Sponsor: Eskisehir Osmangazi University
• Investigators: Study Director: Fulya Bakılan, Assoc Prof, Eskisehir Osmangazi University

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2023
• Primary Completion (Actual): August 15, 2023
• Study Completion (Actual): October 25, 2023

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: chronic pain; sarcopenia; pseudoexfoliation syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Eye Diseases; Pain; Neurologic Manifestations; Disease; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Uveal Diseases; Muscular Atrophy; Atrophy; Iris Diseases; Syndrome; Chronic Pain; Sarcopenia; Exfoliation Syndrome
• Other Study ID Numbers: SarcoPEX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No