Clinical trial NCT06591715: Investigation of Biopsychosocial Characteristics of Individuals with Knee Osteoarthritis
Official title: Investigation of Biopsychosocial Characteristics of Individuals Diagnosed with Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Osteoarthritis (OA) of the Knee
Keywords: osteoarthritis
biopsychosocial
depression
social isolation
pain
sleep
functionality
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of individuals who come to the university hospital for routine controls.

Brief summary: 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: Inclusion Criteria:

* 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
* Having read and signed the informed consent

Exclusion Criteria:

* 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
* Having collagen tissue disease
* History of peripheral vascular disease or neuropathy
* Being in stage 4 according to Kellgren Lawrence radiologic staging criteria
* To have received a physiotherapy program for the relevant knee in the last 3 months

Primary outcomes:
measure: Cognitive Exercise Therapy Approach (BETY)- Biopsychosocial Questionnaire
timeFrame: 3 mounths
Secondary outcomes:
measure: Health Asessement Questionnaire (HAQ)
timeFrame: 3 mounths
measure: Hospital Anxiety Depression Scale (HADS)
timeFrame: 3 mounths
measure: Short Form - 36
timeFrame: 3 mounths
measure: WOMAC Osteoarthritis Index
timeFrame: 3 mounths
measure: Pain Catastrophizing Scale
timeFrame: 3 mounths
measure: Tampa Scale of Kinesiophobia
timeFrame: 3 mounths
measure: Time Up and Go Test
timeFrame: 3 mounths
measure: Stair Climb Test
timeFrame: 3 mounths
measure: 30s Sit to Stand test
timeFrame: 3 mounths
measure: 10 m Walk Tets
timeFrame: 3 mounths
measure: 6 min Walk Test
timeFrame: 3 mounths
measure: Muscle Strength
timeFrame: 3 mounths
measure: Muscle Endurance
timeFrame: 3 mounths
measure: Proprioception
timeFrame: 3 mounths
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Altındağ
Study officials:
References: