Osteoarthritis (OA) of the KneeNCT06591715
Investigation of Biopsychosocial Characteristics of Individuals with Knee Osteoarthritis
An observational study of Osteoarthritis (OA) of the Knee, run by Aysima Barlak at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis (OA) of the Knee
- What is being tested?
- Home exercise program
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 9 Sep 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of individuals who come to the university hospital for routine controls.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Hacettepe University
Ankara, Altındağ, 06100
Aysima Barlak, License, 0-312-305 25 25
About this study
Official title: Investigation of Biopsychosocial Characteristics of Individuals Diagnosed with Knee Osteoarthritis
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.
- Conditions
- Osteoarthritis (OA) of the Knee
- Being tested
- Home exercise program
- Keywords
- osteoarthritis, biopsychosocial, depression, social isolation, pain, sleep, functionality
- Medical subject headings
- Osteoarthritis, Depression, Social Isolation, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home exercise programOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 mounths
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 3 mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Mar 2025 (estimated)
- Primary completion9 Sep 2027 (estimated)
- Study completion9 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA) of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Aysima Barlak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aysima Barlak, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591715
- Sponsor's protocol ID
- SBA 24/862
- Status last verified
- Aug 2024
- First submitted
- 8 Sep 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Biopsychosocial Characteristics of Individuals Diagnosed with Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06591715
- Acronym / sponsor ID
- SBA 24/862
- Conditions
- Osteoarthritis (OA) of the Knee
- Keywords
- osteoarthritis, biopsychosocial, depression, social isolation, pain, sleep, functionality
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aysima BarlakUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 9 Sep 2027 (estimated)
- Study completion
- 9 Sep 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of individuals who come to the university hospital for routine controls.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home exercise programThe 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. | Other | – |
Primary outcome
Cognitive Exercise Therapy Approach (BETY)- Biopsychosocial Questionnaire
Time frame: 3 mounths
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.
14 secondary outcomes
Health Asessement Questionnaire (HAQ)
Time frame: 3 mounths
Hospital Anxiety Depression Scale (HADS)
Time frame: 3 mounths
Short Form - 36
Time frame: 3 mounths
WOMAC Osteoarthritis Index
Time frame: 3 mounths
Pain Catastrophizing Scale
Time frame: 3 mounths
Tampa Scale of Kinesiophobia
Time frame: 3 mounths
Time Up and Go Test
Time frame: 3 mounths
Stair Climb Test
Time frame: 3 mounths
30s Sit to Stand test
Time frame: 3 mounths
10 m Walk Tets
Time frame: 3 mounths
6 min Walk Test
Time frame: 3 mounths
Muscle Strength
Time frame: 3 mounths
Muscle Endurance
Time frame: 3 mounths
Proprioception
Time frame: 3 mounths
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis (OA) of the Knee
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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RecruitingPhase 3
A Study to Learn About Study Medicine Called Berobenatide in Adults With Knee Pain and Overweight or Obesity (VESPER-OA 1)
Obesity, Overweight
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A Study to Learn About Berobenatide Given Once Weekly in Adults With Knee Osteoarthritis and Overweight or Obesity With or Without Type 2 Diabetes (VESPER-OA 2)
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Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
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RecruitingPhase 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis (OA) of the Knee, run by Aysima Barlak at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aysima Barlak, Licence (5412311754, fztasyimabarlak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Exercise Therapy Approach (BETY)- Biopsychosocial Questionnaire (time frame: 3 mounths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.