Clinical trial NCT06121154: Pseudoexfoliation Syndrome, Sarcopenia and Chronic Pain
Official title: A Possible Association Between Pseudoexfoliation Syndrome, Sarcopenia and Chronic Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Pseudoexfoliation Syndrome
Keywords: sarcopenia
pseudoexfoliation syndrome
chronic pain
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 96
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: SARC-F
timeFrame: Baseline
Secondary outcomes:
measure: Grip strength
timeFrame: Baseline
measure: Visual analog scale
timeFrame: Baseline
measure: The chair rise test
timeFrame: Baseline
measure: Gait speed
timeFrame: Baseline
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Eskişehir Osmangazi University
Study officials:
affiliation: Eskişehir Osmangazi University
name: Fulya Bakılan, Assoc Prof
role: STUDY_DIRECTOR
References: