Quality of Life Clinical Trial
Official title:
Investigation of Individuals With Osteoarthritis in Terms of ICF Components Based of ICF Comprehensive Core Set for Osteoarthritis and Quality of Life
NCT number | NCT04956510 |
Other study ID # | PAU |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2019 |
Est. completion date | April 30, 2020 |
Verified date | July 2021 |
Source | Pamukkale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | April 30, 2020 |
Est. primary completion date | February 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Pamukkale University School of Physical Therapy and Rehabilitation | Denizli |
Lead Sponsor | Collaborator |
---|---|
Pamukkale University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Western Ontario and McMaster Universities (WOMAC) OA Index: | 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. | 15 min | |
Primary | Nottingham Health Profile (NHP): | 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 | 15 min |
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