Osteo Arthritis of the KneeNCT07496203
The Effectiveness of BETY in Knee Osteoarthritis With Intra-Articular Injections
A study testing BETY in people with Osteo Arthritis of the Knee and Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Osteoarthritis (OA) is the most common condition in middle-aged and elderly populations; it causes pain and physical disability and is characterized by cartilage degeneration, changes in bone tissue, inflammation of the synovial membrane, and an increased inflammatory response. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteo Arthritis of the Knee, Pain, Pain Management
- What is being tested?
- BETY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2026to Dec 2027
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
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
- having received an intra-articular injection in the knee within the past month
- 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, 1 recruiting
- Recruiting
Hacettepe University
Ankara, Samanpazarı, 06100
Edibe Ünal, 03123052525, edibeunal@yahoo.com
About this study
Official title: An Investigation of the Effectiveness of the BETY Exercise Program, Based on the Biopsychosocial Model, in Individuals With Knee Osteoarthritis Who Have Received Intra-articular Injections
Osteoarthritis (OA) is the most common condition in middle-aged and elderly populations; it causes pain and physical disability and is characterized by cartilage degeneration, changes in bone tissue, inflammation of the synovial membrane, and an increased inflammatory response. Because pain and depression often co-occur in individuals diagnosed with OA, the concepts of disability and health-related quality of life caused by the disease have become more decisive than radiological joint damage. The chronic nature of the disease, like other chronic conditions, encompasses a range of biopsychosocial impacts, including pain, fatigue, sleep disturbances, functional loss, anxiety, depression, and social isolation. This complex structure is accompanied by a pattern in which inflammatory processes are triggered. Recently, intra-articular injections (such as Platelet-Rich Plasma Therapy (PRP), Hyaluronic Acid (HA), PRP+HA combinations, Corticosteroids, Prolotherapy, and Stem Cells) have been accepted as a treatment for OA. Regarding the mechanism of these intra-articular injections, it has been reported that a combination of various anabolic and anti-inflammatory cytokines may treat inflammation associated with the early stages of OA. It has been demonstrated that, through the effects of various growth factors, these treatments have a positive impact on chondrogenesis and mesenchymal stem cell proliferation by increasing anti-inflammatory mediators and reducing pro-inflammatory mediators.
Bilişsel Egzersiz Terapi Yaklaşımı - BETY (Cognitive Exercise Therapy Approach in english) is an exercise approach based on the biopsychosocial model. BETY consists of innovations in function-oriented body stabilization exercises (FoGSE), chronic pain management (BETY-Nociplastic Pain Management (BETY-NPM)), emotion-mood information management (dance therapy-authentic movement), and sexuality information management. The aim of this study is to investigate the effectiveness of BETY, which is often initiated following intra-articular injections-a treatment frequently chosen for individuals diagnosed with knee osteoarthritis (OA).
- Conditions
- Osteo Arthritis of the Knee, Pain, Pain Management, Exercise
- Being tested
- BETY
- Medical subject headings
- Pain, Agnosia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BETYOther
Participants in this group will follow a traditional exercise program consisting of active range-of-motion exercises for the knee joint, isometric muscle strengthening, and stretching exercises targeting the lower extremity muscle groups.
| Study group | Role | What they receive |
|---|---|---|
| BETY Group | Active comparator | BETY Exercise Group Receives: Other: BETY |
| Control Group | Active comparator | Control group Receives: Other: BETY |
| Traditional Exercise Group | Active comparator | Traditional Exercise Group Receives: Other: BETY |
What is being measured
The primary outcome is the main question the study is designed to answer.
BETY-BQ
The BETY-BQ 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: 6 months
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: 6 months
Secondary outcomes (13)
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: 6 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: 6 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: 6 months
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: 6 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: 6 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: 6 months
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: 6 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: 6 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: 6 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: 6 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: 6 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: 6 mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start2 Jan 2026
- Primary completion20 Mar 2026
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis of the KneeStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysima Barlak, Hacettepe University
- Investigators
- Edibe Ünal, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496203
- Sponsor's protocol ID
- FTREK25_143
- Status last verified
- Dec 2025
- First submitted
- 23 Mar 2026
- Last updated
- 27 Mar 2026
- 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 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Effectiveness of the BETY Exercise Program, Based on the Biopsychosocial Model, in Individuals With Knee Osteoarthritis Who Have Received Intra-articular Injections
- ClinicalTrials.gov ID
- NCT07496203
- Acronym / sponsor ID
- FTREK25_143
- Conditions
- Osteo Arthritis of the Knee, Pain, Pain Management, Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Mar 2026 (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.
Osteoarthritis (OA) is the most common condition in middle-aged and elderly populations; it causes pain and physical disability and is characterized by cartilage degeneration, changes in bone tissue, inflammation of the synovial membrane, and an increased inflammatory response. Because pain and depression often co-occur in individuals diagnosed with OA, the concepts of disability and health-related quality of life caused by the disease have become more decisive than radiological joint damage. The chronic nature of the disease, like other chronic conditions, encompasses a range of biopsychosocial impacts, including pain, fatigue, sleep disturbances, functional loss, anxiety, depression, and social isolation. This complex structure is accompanied by a pattern in which inflammatory processes are triggered. Recently, intra-articular injections (such as Platelet-Rich Plasma Therapy (PRP), Hyaluronic Acid (HA), PRP+HA combinations, Corticosteroids, Prolotherapy, and Stem Cells) have been accepted as a treatment for OA. Regarding the mechanism of these intra-articular injections, it has been reported that a combination of various anabolic and anti-inflammatory cytokines may treat inflammation associated with the early stages of OA. It has been demonstrated that, through the effects of various growth factors, these treatments have a positive impact on chondrogenesis and mesenchymal stem cell proliferation by increasing anti-inflammatory mediators and reducing pro-inflammatory mediators.
Bilişsel Egzersiz Terapi Yaklaşımı - BETY (Cognitive Exercise Therapy Approach in english) is an exercise approach based on the biopsychosocial model. BETY consists of innovations in function-oriented body stabilization exercises (FoGSE), chronic pain management (BETY-Nociplastic Pain Management (BETY-NPM)), emotion-mood information management (dance therapy-authentic movement), and sexuality information management. The aim of this study is to investigate the effectiveness of BETY, which is often initiated following intra-articular injections-a treatment frequently chosen for individuals diagnosed with knee osteoarthritis (OA).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BETY Group | Active comparator | Other: BETYBETY Exercise Group |
| Control Group | Active comparator | Other: BETYControl group |
| Traditional Exercise Group | Active comparator | Other: BETYTraditional Exercise Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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
- having received an intra-articular injection in the knee within the past month
- To be 18 years of age or older
- Being a reader-writer
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 |
|---|---|---|
| BETYParticipants in this group will follow a traditional exercise program consisting of active range-of-motion exercises for the knee joint, isometric muscle strengthening, and stretching exercises targeting the lower extremity muscle groups. | Other | BETY Group, Control Group, Traditional Exercise Group |
Primary outcome
BETY-BQ
Time frame: 6 months
The BETY-BQ 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.
Muscle Strength
Time frame: 6 months
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.
13 secondary outcomes
Health Asessement Questionnaire (HAQ)
Time frame: 6 mounths
Hospital Anxiety Depression Scale (HADS)
Time frame: 6 mounths
Short Form - 36
Time frame: 6 months
WOMAC Osteoarthritis Index
Time frame: 6 mounths
Pain Catastrophizing Scale
Time frame: 6 mounths
Tampa Scale of Kinesiophobia
Time frame: 6 months
Time Up and Go Test
Time frame: 6 mounths
Stair Climb Test
Time frame: 6 mounths
30s Sit to Stand test
Time frame: 6 mounths
10 m Walk Tets
Time frame: 3 mounths
6 min Walk Test
Time frame: 6 mounths
Muscle Endurance
Time frame: 6 mounths
Proprioception
Time frame: 6 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 27 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Edibe Ünal study chair
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BETY in people with Osteo Arthritis of the Knee and Pain, run by Hacettepe University 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 6 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: looking for participants now, as of the sponsor's last update on 27 Mar 2026. 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, PT, MSc (+903123052525, fztaysimabarlak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BETY-BQ (time frame: 6 months). The study lists 2 primary outcomes in all. 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 27 Mar 2026.