Investigation of Biopsychosocial Characteristics of Individuals with Knee Osteoarthritis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAysima Barlak

About this trial

Since pain and depression are observed together in rheumatic diseases, the concept of limitation caused by the disease and health-related quality of life becomes more determinant than radiological joint damage. Sleep problems observed in OA also increase the level of depression findings and difficulty in movement. The chronic nature of the disease includes issues such as pain, fatigue, sleep problems, loss of function, anxiety, depression, and social isolation, together as in other chronic diseases. This complex structure accompanies a picture in which inflammatory processes are triggered.

When the literature is examined, the necessity of evaluation and methods including all these biopsychosocial characteristics of chronic diseases with multifaceted symptoms is emphasized. On the other hand, although it is stated that the common goal of non-pharmacological treatments is to contribute to biopsychosocial improvement in the patient, it is emphasized that evaluations with biopsychosocial content are insufficient. This situation causes the need for scales that provide a holistic assessment of chronic diseases. When the literature, including individuals diagnosed with osteoarthritis, is analyzed, the inadequacy of the studies providing biopsychosocial evaluation draws attention.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of knee osteoarthritis according to ACR knee osteoarthritis diagnostic criteria

Being in stage 2 or 3 according to Kellgren-Lawrence radiological staging criteria

To be 18 years of age or older

Being a reader-writer

Disqualifiers

History of major psychiatric illness

Having malignant disease

Having chronic infectious or other rheumatologic diseases

Serious knee trauma or surgical operation in the last 6 months

Trial population

The study population will consist of individuals who come to the university hospital for routine controls.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Home exercise program

    Other intervention

    The home exercise program routinely given to individuals with knee OA in addition to their medical treatment will consist of exercises routinely used in the BETY innovation.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Cognitive Exercise Therapy Approach (BETY)- Biopsychosocial Questionnaire

The BETY Questionnaire was developed on rheumatic patients and was introduced to the literature as a standardized biopsychosocial measurement tool as a result of improving the definitions of recovery from patients with expert opinions and statistical analysis. Scoring of the scale is done using a 5-point Likert system, each item is scored between 0 and 4 points, and a high total score in the scale consisting of a total of 30 items indicates a high biopsychosocial impact.

Time frame
3 mounths

Secondary outcomes

1

Health Asessement Questionnaire (HAQ)

It is a questionnaire developed in individuals with rheumatoid arthritis and can be used widely and extensively in all rheumatic disease groups and in a wide range of populations including OA. It has 8 subheadings and consists of a total of 20 questions. The sub-headings include dressing, sitting and staying, eating, walking, hygiene, reaching, grasping and activities of daily living. Each answer is scored between 0 and 3 points and the higher the score, the more difficult the activity is.

Time frame
3 mounths
2

Hospital Anxiety Depression Scale (HADS)

Although the HADS was developed 20 years ago for the clinical measurement of anxiety and depression levels and was originally developed for hospitalized individuals, it now has a wide spectrum of use and can be used in many situations, including healthy people. Seven of the 14 items provide insight into the level of anxiety, while seven include questions about the level of depression. Each question is scored between 0 and 3, with a higher score indicating higher affect. Anxiety and depression sub-parameters are scored separately and a score of 11 and above is considered abnormal.

Time frame
3 mounths
3

Short Form - 36

SF-36 scale will be used to determine the level of health status and quality of life of individuals.SF-36 is a patient-oriented assessment scale created in the United States of America that allows for general health screening.Each sub-parameter is scored between 0 and 100 points and a high score indicates good health status.The SF-36 scale has 8 sub-parameters including general health perception, physical function, social function, pain, mental health, role difficulties due to physical causes, role difficulties due to emotional causes and vitality and includes 11 questions with a total of 36 items.

Time frame
3 mounths
4

WOMAC Osteoarthritis Index

The most commonly used disease-specific questionnaire for the assessment of disease severity in hip or knee OA is the WOMAC questionnaire recommended by the Outcome Measures in Rheumatology Clinical Trials. WOMAC assesses pain, endurance and physical functioning, functional status and stiffness. This scale has gained increasing acceptance in the assessment of OA since its introduction in 1986. The pain subscale includes five items asking about pain with activity, at rest and at night. The stiffness heading includes two questions. The functional status heading includes an assessment of difficulty in 17 different activities. The items are scored from 0 to 4 according to difficulty and the degree of pain and stiffness felt, with a higher total score indicating greater severity of the disease.

Time frame
3 mounths

Other outcomes

Sponsors and contacts

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Aysima Barlak

Lead sponsor

Hacettepe University

Sponsor institution

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