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OpenTrials
Completed

NCT Number: NCT04956510

Osteoarthritis in Terms of ICF Components

Osteoarthritis (OA) is a common degenerative disease associated with functional impairments, activity limitations, participation restrictions, as well as poor quality life. Therefore, the comprehensive assessment is important to determine how complex problems affect patients with OA. The first aim of this study was to link and allocate items of The Western Ontario and McMaster Universities (WOMAC) OA index with ICF Comprehensive Core Set for osteoarthritis. The second aim was to examine the relationship between the quality of life and each ICF component's scores determined based on clinical data of WOMAC in OA.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases OUTCOME MEASURES Quality of Life Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pamukkale University School of Physical Therapy and Rehabilitation

Denizli, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosed with OA according to American College of Rheumatology clinical criteria for OA of the knee or hip;[14,15]
  • being in the age range 18-65; and
  • absence of other diseases affecting functions and daily life (orthopedic, neurological, cardiovascular, metabolic disease and lung pathology).

Exclusion criteria

  • comorbidity affecting lower extremity and functions (patellofemoral pain syndrome, rheumatoid arthritis, ligament tear, meniscus);
  • previous lower extremity surgery;
  • Intra-articular steroid or hyaluronic acid injection in the last three months
  • cognitive impairments;
  • pregnancy; and
  • illiteracy.

Treatment and study plan

Evaluation

Other

health status and quality of life were evaluated

Primary outcomes

  1. The Western Ontario and McMaster Universities (WOMAC) OA Index:

    Time frame: 15 min

    The WOMAC Index is a self-administered, disease-specific questionnaire consisting of 24 items which are widely used in the evaluation of hip and knee OA. It consists of 24 items: pain (5 items), stiffness (2 items), and physical function (17 items). High score indicates worse pain, stiffness, and functional limitations.

  2. Nottingham Health Profile (NHP):

    Time frame: 15 min

    NHP is a widely used measure of perceived distress of patients in physical, emotional and social domains. It consists of 38 items which are physical mobility (8 items), pain (8 items), sleep (5 items), emotional reactions (9 items), social isolation (5 items) and energy level (3 items). Questions have "yes" or "no" answers. Higher score indicates greater distress

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

Investigation of Individuals With Osteoarthritis in Terms of ICF Components Based of ICF Comprehensive Core Set for Osteoarthritis and Quality of Life

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 9, 2021
Registry last updated
Jul 9, 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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