120 patients with Kellgren-Lawrence grade 2-3 knee osteoarthritis will be randomized into four groups: Control group, Extracorporeal shock wave therapy (ESWT) (once a week for 3 sessions), Low-level laser therapy (LLLT) (twice a week for 8 sessions), and Pulsed electromagnetic field therapy (PEMF) (twice a week for 8 sessions), with 30 patients in each group. All participants will be instructed in a daily exercise program, including knee joint range of motion, stretching, and strengthening exercises (3×10 repetitions). Outcome measures, including the Visual Analogue Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Short Form-36 (SF-36), and Timed Up \& Go (TUG) test, will be assessed at baseline after treatment and at 3rd month.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
The ESWT will be administered using an ESWT device (Modus ESWT Compact Model-Portable) once weekly over three consecutive weeks, resulting in a total of three sessions. A radial shockwave mode was chosen for the therapy. During each session, participants will receive 3000 pulses at an 12-Hz frequency and pneumatic pressure of 2.5 bars
The MLS (Multiwave Locked System) laser is a specific type of low-level laser therapy (LLLT) that combines two different wavelengths of light-typically 808 nm (near-infrared) and 905 nm (mid-infrared)-to produce therapeutic effects. These wavelengths are delivered simultaneously in a synchronized manner, which is intended to enhance the overall effectiveness of the treatment. LLLT will be conducted with the laser device (MLS Laser M6 Robotic Multiwave Lock System, Asalaser, Italy) with the use of protective goggles, and the treatment parameters were set as follows: 100% power, 3 Joules per treatment spot with 904 nm wavelength, and a treatment area of 20 cm². The LLLT will be applied to five points on the anterior part of the joint space, with each point treated for 3 minutes, totaling 15 minutes. A total of 8 sessions were applied for 4 weeks, 2 days a week.
For PEMF, the applicator of the device (Easy QS Magnetotherapy Portable Magnetotherapy Medical Device, Asalaser, Italy) will be positioned to target the medial and lateral aspects of the knee. The treatment parameters were defined as follows: rectangular field shape, 30 Hz frequency, 10 mT intensity, and a duration of 20 minutes. A total of 8 sessions were applied for 4 weeks, 2 days a week.
Istanbul Medeniyet University Goztepe Prof Dr Suleyman Yalcin City Hospital
Istanbul, None Selected, Turkey (Türkiye)
Visual Analogue Scale (VAS)
Pain assessment in the study was conducted using the VAS, which ranges from 0 to 10. Patients were instructed to evaluate the pain they experienced. A score of "0" signified the absence of pain, whereas a score of "10" denoted the most intense pain they had ever encountered in their lifetime.
Time frame: baseline after treatment and at 3rd month
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The WOMAC OA Index is a questionnaire completed by the patient to assess pain, stiffness, and physical function related to knee and hip osteoarthritis. It consists of 24 questions addressing pain, stiffness, and physical function. The index provides both a total score and separate subscores for each category. Higher scores indicate poorer outcomes in that category.
Time frame: baseline after treatment and at 3rd month
Short Form-36 (SF-36)
Among quality of life scales, the SF-36 is a generic scale that provides a broad assessment. It comprises 36 items that assess eight dimensions: physical functioning (PF), social functioning (SF), role limitations due to physical health (RLPH), role limitations due to emotional problems (RLEP), emotional well-being (EW), energy/fatigue (E), pain (P), general health (GH) and health change (HC).
Time frame: baseline after treatment and at 3rd month
Timed Up & Go Test (TUG)
This test is designed to assess dynamic balance and functional mobility. The test requires a chair, a stopwatch, and a 3-meter walking space. It begins with the individual seated in a chair. Upon receiving the instruction, the individual stands up, walks 3 meters at a regular speed, turns around, walks back to the starting point, and then sits down again. The time taken to complete the test is recorded in seconds for scoring purposes.
Time frame: baseline after treatment and at 3rd month
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