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Clinical Trials/NCT04956510
NCT04956510
Completed
Not Applicable

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

Pamukkale University1 site in 1 country100 target enrollmentNovember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
Pamukkale University
Enrollment
100
Locations
1
Primary Endpoint
Nottingham Health Profile (NHP):
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2019
End Date
April 30, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elif Gur Kabul

MSc, PT, Research Assistant

Pamukkale University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

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.

Study Sites (1)

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