Hacettepe University
Ankara, Samanpazarı, 06100, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07496203
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Ankara, Samanpazarı, 06100, Turkey (Türkiye)
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 6 mounths
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: 6 mounths
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: 6 months
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: 6 mounths
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: 6 mounths
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: 6 months
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: 6 mounths
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: 6 mounths
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: 6 mounths
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
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: 6 mounths
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: 6 mounths
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: 6 mounths
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.
Contact information is provided by the study sponsor or research team.
Aysima Barlak, PT, MSc
CONTACT
Edibe Ünal, PT, Prof
CONTACT
Hacettepe University
Other
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
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