NCT04956510

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 9, 2021

Completed
Last Updated

July 9, 2021

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

July 2, 2021

Last Update Submit

July 2, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Interventions

health status and quality of life were evaluated

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Eighty-seven patients with OA were included in this study, who met inclusion criteria and were diagnosed with OA by the same rheumatologist according to the American College of Rheumatology Clinical Classification Criteria for OA.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University School of Physical Therapy and Rehabilitation

Denizli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, PT, Research Assistant

Study Record Dates

First Submitted

July 2, 2021

First Posted

July 9, 2021

Study Start

November 1, 2019

Primary Completion

February 10, 2020

Study Completion

April 30, 2020

Last Updated

July 9, 2021

Record last verified: 2021-07

Locations