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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).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Aysima Barlak, PT, MSc contact

+903123052525

fztaysimabarlak@gmail.com

Edibe Ünal, PT, Prof contact

03123052525

edibeunal@yahoo.com

Turkey (Türkiye)1 site, 1 recruiting
  • Hacettepe University

    Ankara, Samanpazarı, 06100

    Edibe Ünal, 03123052525, edibeunal@yahoo.com

    Recruiting

Other trials in Turkey (Türkiye)

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).

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 groups in NCT07496203
Study groupRoleWhat they receive
BETY GroupActive comparatorBETY Exercise Group
Receives: Other: BETY
Control GroupActive comparatorControl group
Receives: Other: BETY
Traditional Exercise GroupActive comparatorTraditional Exercise Group
Receives: Other: BETY

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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)
  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.

    Measured: 6 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.

    Measured: 6 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.

    Measured: 6 months

  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

    Measured: 6 mounths

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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. 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

  11. 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

  12. 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

  13. 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.

  1. First posted27 Mar 2026
  2. Study start2 Jan 2026
  3. Primary completion20 Mar 2026
  4. Study completionDec 2027 (estimated)

Resources

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)
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

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.

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