Clinical Trial Radar

VAS (Visual Analog Scale)

The visual analog scale (VAS) is a widely accepted measurement tool in the scientific literature used to quantify subjective variables that cannot be directly measured numerically. It consists of a 100-mm horizontal line, with each end representing the extreme limits of the parameter being assessed, ranging from no pain to very severe pain. Patients are asked to mark the point on the line that best reflects their current pain intensity. The distance measured from the no-pain endpoint to the patient's mark indicates the level of pain. The VAS is a safe, easy-to-use, and valid instrument for assessing pain intensity.

Pain measurements using the VAS will be obtained at baseline (week 0), 1 week after completion of treatment (week 3), and 3 months after completion of treatment (week 14).

WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a valid and reliable disease-specific instrument widely used to assess disability in patients with osteoarthritis. It consists of three subscales: pain (5 items), stiffness (2 items), and physical function (17 items). Each item is scored on a Likert scale ranging from 0 to 4, reflecting the level of impairment. Subscale scores are calculated separately and combined to yield a total score ranging from 0 to 100, with higher scores indicating increased pain and stiffness and greater impairment in physical function. The Turkish validity and reliability of the WOMAC were established by Tüzün and colleagues.

The WOMAC will be assessed at baseline (week 0), 1 week after completion of treatment (week 3), and 3 months after completion of treatment (week 14).

SF-36 (Short Form 36 Health Survey)

The Short Form-36 (SF-36) is a widely used instrument for assessing patients' overall health status and quality of life, with established validity and reliability in Turkish populations. The scale consists of 36 items across 8 subscales: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional health, and mental health. Each item is scored individually, and scores are calculated to produce a total score ranging from 0 to 100, with higher scores indicating better quality of life and lower scores indicating poorer quality of life.

Quality of life will be assessed using the SF-36 at baseline (week 0), 1 week after completion of treatment (week 3), and 3 months after completion of treatment (week 14).

Distal femoral cartilage thickness

The distal femoral cartilage thickness of all participants will be assessed by the same researcher experienced in musculoskeletal ultrasonography using an ultrasound device (Logiq P5, GE Medical Systems, USA) equipped with a linear probe operating at a frequency of 5-12 megahertz (MHz). Measurements will be performed with participants in the supine position and knees in maximum flexion. The ultrasound probe will be positioned perpendicular to the articular surface of the femur by placing it transversely on the upper edge of the patella. Cartilage will be identified as a hypoechoic structure located between the suprapatellar fat pad and the bone cortex. Thickness measurements will be taken at three sites: the midpoint of the medial condyle, the intercondylar notch, and the lateral condyle. Measurements will be based on the distance between the bone-cartilage interface and the cartilage-fat pad interface.

Distal femoral cartilage thickness will be measured at baseline (week 0), 1 week after completion of treatment (week 3), and 3 months after completion of treatment (week 14) for each participant.

Medial Collateral Ligament thickness

The medial collateral ligament (MCL) of all participants will be assessed by the same researcher experienced in musculoskeletal ultrasonography using a linear probe ultrasound device (Logiq P5, GE Medical Systems, USA) operating at a frequency of 5-12 megahertz (MHz). During assessment, participants will be positioned supine with their knees fully extended. After visualizing the joint space, the MCL will be imaged in the vertical plane along the medial side of the knee. Thickness measurements will be taken at two points: approximately 1 cm proximal to the joint line on the femoral side and 1 cm distal to the joint line on the tibial side.

Medial collateral ligament (MCL) thickness will be measured at baseline (week 0), 1 week after completion of treatment (week 3), and 3 months after completion of treatment (week 14) for each participant.