Reliability and Validity of Turkish Version of Knee Injury and Osteoarthritis Outcome Score-12 (KOOS-12)

February 18, 2021 updated by: Leyla Ataş Balcı, Bahçeşehir University
Approximately 120 patients who have been diagnosed with knee osteoarthritis but have not previously operated due to this disease and who are in Kellgren Lawrence stage 2 and 3 will be compared with the KOOS scale and Short Form-36 (Short Form-36: SF-36) scales to investigate the validity and reliability of the Turkish version of KOOS-12.

Study Overview

Status

Completed

Detailed Description

Osteoarthritis (OA) is a chronic degenerative disease characterized by the loss of articular cartilage, causing destruction in periarticular bone tissue, leading to a decrease in daily life and quality of life due to pain despite its slow progression.

When the knee osteoarthritis Looking at the prevalence among people living in Turkey, compared to males more can be seen, 14.8% of the 50 and older population in knee OA incidence, 22.5% of the incidence in women, while men were determined to be 8%.

Risk factors that affect the development of knee OA include obesity, traumas, chondrocalcinosis, nutritional factors, genetics, smoking, estrogen replacement, muscular weakness, and professional or sports activities. The individual with knee OA especially; It is applied to the physician with the complaints of increased pain during walking, climbing and climbing stairs, stiffness in the joint, crepitation and limited range of motion.

Diagnosis is determined based on knee OA, clinical and radiological evaluations; According to the radiological changes seen, the stage of the disease is determined by Kellgren Lawrence staging (Stage 0-4). Purposes in the treatment of knee OA; patient education, pain control, increasing functionality and reducing the impact of disability on daily life. The optimal treatment approach involves the application of non-pharmacological and pharmacological treatments together.

Functional evaluation methods are of great importance in planning the right treatment approach and evaluating treatment effectiveness due to the negative impact of individuals on daily life activities. Functional evaluation of the individual; daily life activities, professional activities, leisure activities, social relationships and their skills in performing these tasks are carried out with objective, generic or disease-specific scales. Various scales have been developed in individuals with knee OA that allow an objective evaluation of functions. Among these scales, Western Ontario and McMaster Universities Osteoarthritis Index (Western Ontario and McMaster Universities Osteoarthritis Index: WOMAC), Lequesne Index, Knee-Hip Osteoarthritis Life Quality Scale (Osteoarthritis of Knee Hip Quality Of Life Questionnaire: OAKHQOL), Knee osteoarthritis and Knee Injury and Knee Injury and Osteoarthritis Outcome Score: KOOS.

These questionnaires, which are reported by the patients, are not routinely used in the clinic due to the length of the questionnaires, which are used to determine the problems caused by joint problems in daily life and quality of life. Therefore, patient-based scales that can be used in the clinic should be short, and include questions that can evaluate pain, function and quality of life. Although the short form of the KOOS questionnaire has been developed, KOOS-PS only measures the effects of knee osteoarthritis on physical function. Consisting of 12 questions considering that the KOOS scale is long in routine, clinic use; A short form of KOOS-12 was created, which included the assessment sections of pain, function and knee-specific quality of life. The application of the KOOS-12 scale takes 2 minutes. The short form of KOOS-12 was found to be a valid and reliable scale in individuals who underwent total knee arthroplasty. The purpose of our study; Turkish reliability and validity of the Knee Osteoarthritis and Knee Injury and Osteoarthritis Result Score-12 scale.

Study Type

Observational

Enrollment (Actual)

135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beşiktaş/İstanbul
      • İstanbul, Beşiktaş/İstanbul, Turkey, 34340
        • Alptekin Physical Therapy and Rehabilitation Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

In determining the individuals who will participate in the study; face to face interviews and social media groups (whatsapp, facebook, instagram etc.) will be used. Individuals diagnosed with osteoarthritis by the physician at the Alptekin Physical Therapy Clinic will be included.

Description

Inclusion Criteria:

  • The study resides in the province of Istanbul
  • 18 years and older
  • Who have been diagnosed with knee osteoarthritis
  • In Kellgren Lawrence Staging; Stage 2 and 3 detected
  • Not operated after knee osteoarthritis after diagnosis
  • Literate
  • 120 individuals who agree to participate in the study will be included. For the validity of the questionnaire, it must be applied to at least 10 times the number of questions in the questionnaire. In this context, it is planned to be included in the study with at least 120 people.

Exclusion Criteria:

  • Those diagnosed with hip and ankle OA
  • Those with neurological diseases affecting their lower extremities
  • Those with knee pain due to rheumatoid arthritis, anterior cruciate ligament injury and menisectomy
  • Those who had a total knee arthroplasty operation in the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee injury and Osteoarthritis Outcome Score-12 (KOOS-12)
Time Frame: change from baseline activities od daşly living at 2 weeks
Scale; It consists of three parts: pain (4 items), function (4 items) and knee-specific quality of life (4 items). KOOS-12; in pain sub-item; In the sub-item of walking on a flat ground, going up and down stairs, sitting-reaching, function and daily life; There are patient-specific questions in the sub-item of quality of life, sitting up, standing, getting in and out of the car, turning the affected knee. The total scores obtained from the items in the KOOS-12 scale are calculated and the average of the total score is taken from the three sub-dimensions. If any of the three sub-item scores are missing, the average score cannot be calculated.
change from baseline activities od daşly living at 2 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: change from baseline activities od daşly living at 2 weeks
It is a questionnaire designed by Roos et al. From the Likert 3.0 version of the WOMAC osteoarthritis index to evaluate the pain, functional status, daily life activity and quality of life of patients with knee osteoarthritis (Roos EM. et al. 1998). Scale; consists of five subgroups and 42 questions: pain, string-related quality of life, daily life activities, sports and leisure activities. Individuals score the questions between 0-4 according to the 5-point Likert scale, based on the symptoms felt in the knee, taking into account the past week. While 100 points indicate that there are no symptoms in the scale, 0 points indicate that there are severe symptoms. The subscale score is calculated by dividing the average scores of each sub-dimension separately into 4. The Turkish validity and reliability study of the scale was conducted. (Sabırlı F. et al. 2007). It takes 10 minutes to apply the scale (Roos EM. et al. 2003, Paker N. et al. 2007).
change from baseline activities od daşly living at 2 weeks
Short Form-36 (SF-36)
Time Frame: change from baseline activities od daşly living at 2 weeks
It is a scale that is used to evaluate the overall quality of life consisting of eight sub-scales and 36 questions and allows the individual to evaluate himself. Scale; physical function, physical role, emotional role, pain, vitality, general health and mental health sub-dimensions. Each subscale is scored between 0-100 and "0" indicates the lowest and "100" shows the best quality of life. The questionnaire has Turkish validity and reliability (Kocyigit H. et al. 1999).
change from baseline activities od daşly living at 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 20, 2020

Primary Completion (ACTUAL)

March 25, 2020

Study Completion (ACTUAL)

April 25, 2020

Study Registration Dates

First Submitted

February 6, 2020

First Submitted That Met QC Criteria

February 18, 2020

First Posted (ACTUAL)

February 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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