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Completed

NCT Number: NCT04749537

Work Productivity and Social Activities In Patients With Ankylosing Spondylitis

The aim of this study is to evaluate the relationship between decrease in work productivity and social activities in patients with Ankylosing Spondylitis (AS) with disease activity, depression and quality of life together with demographic data.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Derya Bugdayci, Assoc Prof

Istanbul, Turkey (Türkiye)

About this study

For this study, which is planned as a cross-sectional clinical study, 100 patients who were diagnosed with AS between the ages of 18-65 and who applied to the Istanbul Physical Therapy Rehabilitation SUAM Physical Medicine and Rehabilitation Outpatient Clinic between April 15, 2019, and April 15, 2020, and 100 healthy volunteers compatible with age. was included. Demographic data of the participants were recorded. Work productivity and activity reduction questionnaire: general health (WPAI: GH), social role participation questionnaire short form (SRPQ), short form-36 (SF-36), hospital anxiety, and depression scale (HADS), will be evaluated. Besides, if the patient group exists, laboratory results (CRP, erythrocyte sedimentation rate, HLA-B27), and bath ankylosing spondylitis functional index (BASFI), bath ankylosing spondylitis disease activity index (BASDAI), Bath ankylosing spondylitis metrology index (BASMI), visual analog scale (VAS) resting, night and activity values were recorded.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients with AS diagnosis between the ages of 18-65
  • Healthy volunteer individuals between the ages of 18-65 without known musculoskeletal disease

Exclusion criteria

  • Those with serious systemic diseases that may interfere with working (respiratory system, cardiovascular system, renal and metabolic diseases)
  • Those with orthopedic and psychiatric diseases
  • Those with inflammatory diseases other than known AS
  • Pregnant
  • People with disability due to the history of trauma
  • Those with injury after the operation
  • Those with diseases that cause neurological sequelae

Treatment and study plan

Primary outcomes

  1. Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI:GH)

    Time frame: One day

    WPAI: GH measures health impact and symptom severity impact on work productivity and leave time effectiveness

  2. Social Role Participation Questionnaire (SRPQ)

    Time frame: One day

    It is used to evaluate integration into society and activities in social life. It evaluates the level of participation in six social roles in two dimensions: the "experienced physical difficulties scale" and the "role performance satisfaction scale". Participants complete their satisfaction and challenges during their social roles

Secondary outcomes

  1. Short Form Health Survey 36 (SF-36)

    Time frame: One day

    used to evaluate the quality of life

  2. Hospital Anxiety and Depression Scale (HADS)

    Time frame: One day

    used to determine the risk in terms of anxiety and depression in a patient with a physical illness, and to measure the level and change of severity.

  3. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    Time frame: One day

    the assessment of disease activity in patients with ankylosing spondylitis

  4. Bath Ankylosing Spondylitis Functional Index (BASFI)

    Time frame: One day

    the assessment of functional status in patients with ankylosing spondylitis

  5. Bath Ankylosing Spondylitis Metrology Index (BASMI)

    Time frame: One day

    the assessment of the level of spinal mobility in patients with ankylosing spondylitis

  6. Ankylosing Spondylitis Quality of Life (ASQoL)

    Time frame: One day

    used to evaluate the quality of life in patients with ankylosing spondylitis

  7. Visual Analogue Scale (VAS)

    Time frame: One day

    used to evaluate the pain

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

The Relationship Between The Decreasing Activity, Depression And Quality Of Life In Work Productivity And Social Activities In Ankylosing Spondylitis Patients: A Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 11, 2021
Registry last updated
Feb 11, 2021

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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