An observational study in Osteoarthritis (OA) of the Knee, sponsored by Aysima Barlak. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Aysima Barlak · Observational
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.
4,445 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 803 observational studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Aysima Barlak is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of individuals who come to the university hospital for routine controls.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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
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
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
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
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
Pain Catastrophizing Scale
This scale, developed by Sullivan et al. (1995), measures the exaggerated negative mental reaction of individuals to current or anticipated painful experiences and the extent to which they catastrophize pain.The reliability and validity of the Turkish version of the scale was demonstrated by Uğurlu et al. (2017) and consists of 13 items.Each item is scored as never=0, slightly=1, moderately=2, greatly=3 and always=4.A high total score indicates a high degree of catastrophizing of pain.
Time frame: 3 mounths
Tampa Scale of Kinesiophobia
This scale is a 17-question scale developed to measure fear of movement/reinjury.The scale includes parameters of injury/re-injury and fear-avoidance in work-related activities
Time frame: 3 mounths
Time Up and Go Test
The balance status of the individual is evaluated by getting up from a chair with back support, walking 3 meters at a normal walking speed and returning back to the chair and the time he/she sits on the chair is measured and recorded in seconds.The test is repeated 3 times.
Time frame: 3 mounths
Stair Climb Test
In measuring the lower extremity strength and dynamic balance of the individual, the time to ascend and descend 10 steps of 16-20 cm stairs with a handrail as fast as possible is recorded in seconds. The test will be repeated 3 times and the times will be recorded.
Time frame: 3 mounths
30s Sit to Stand test
To assess lower limb strength, the subject is asked to stand upright in a chair with arms crossed over the chest and then sit down again. The subject is asked to repeat as quickly as possible for a period of 30 seconds. The score for this assessment test is the number of times the individual stands up fully from a sitting position with arms crossed within 30 seconds.
Time frame: 3 mounths
10 m Walk Tets
The individual is asked to walk quickly but without running on a 10-meter path. Three repetitions of the assessment are recorded in seconds.
Time frame: 3 mounths
6 min Walk Test
It will be used to assess the functional capacity of the patients. Patients will be asked to walk as long as possible in a 20-meter hospital corridor for 6 minutes in their own rhythm and with standard commands and the distance walked will be recorded in meters.
Time frame: 3 mounths
Muscle Strength
Muscle strength will be assessed using the Biodex System 3 Pro® isokinetic device (Biodex Medical Systems Inc., Shirley, NY, USA). Before the first assessment, participants will be recruited to a familiarization session. Each assessment will be preceded by a 10-minute warm-up walk and participants will perform knee flexor and extensor maximal concentric isokinetic muscle strength tests at angular velocities of 180°/s (10 repetitions) and 60°/s (5 repetitions) with a 30-second rest interval. Peak torque (PT) and average power (AP) will be recorded in Newtons (Nm) and watts (W) per meter.
Time frame: 3 mounths
Muscle Endurance
In order to evaluate muscular endurance, it will be applied with 20 repetitions at 180°/s angular velocity. A rest period of 30 seconds will be given between the tests. Peak torque measurement will be recorded in Newton meters (Nm). Total work during all repetitions will be recorded in Joules (J).
Time frame: 3 mounths
Proprioception
To assess knee proprioception, "active position sense" will be measured at 30°, 45° and 60° by the "Biodex System Pro3 Isokinetic System (Biodex Corp. Shirley NY, USA) as recommended in the literature. Deviation from the target angle will be recorded as absolute angular error, regardless of whether the error is negative or positive. The test will be repeated three times. The mean of the patients\' absolute angular errors at each test angle over 3 repetitions will be processed as data
Time frame: 3 mounths
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Mar 2025; primary completion for Sep 2027, 30 months later.
Of 235 non-industry observational studies under Osteoarthritis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 64. This study's planned 30 months is close to that.
Counting every sponsor, half of 324 studies reached it within 38 months; a quarter within 15 and three quarters within 103.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Aysima Barlak