The Effectiveness of BETY in Knee Osteoarthritis With Intra-Articular Injections
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHacettepe University
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
BETY
Other interventionParticipants 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.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: BETY GroupActive comparator 1 intervention
Group B: Control GroupActive comparator 1 intervention
Group C: Traditional Exercise GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
6 months2
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
6 monthsSecondary outcomes
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.
Time frame
6 mounths2
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
6 mounths3
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
6 months4
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
6 mounthsSponsors and contacts
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Source ClinicalTrials.gov