Comparison of Short-term Effects of Extracorporeal Shock Wave Therapy, Low-level Laser Therapy and Pulsed Electromagnetic Field Therapy in Knee Osteoarthritis

Phase 3

Active, not recruiting

• Conditions: Knee Osteoarthritis

• Registration Number: NCT06717633
• Lead Sponsor: Istanbul Medeniyet University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01-01
• Study First Submitted: 2024-11-30
• Study First Submitted QC: 2024-11-30
• Last Update Submitted: 2024-11-30
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-01-27
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• experiencing knee pain persisting for more than 6 months, radiological assessment confirming grade 2 and grade 3 knee osteoarthritis based on the Kellgren-Lawrence system
• no history of physical therapy or regular use of non-steroidal anti-inflammatory drugs (NSAIDs) within the last 6 months,
• absence of any pathology other than osteoarthritis that could cause knee pain,
• no lumbar spine or hip pathology that could refer pain to the knee,
• free from any conditions that would prevent participation in exercise or physical therapy
• willing to regularly participate the treatment programs were included in the study.

Exclusion Criteria

• presence of a condition that impairs ambulation,
• a documented history of spinal stenosis,
• evidence of a neurological disorder based on medical history or physical examination,
• the existence of an inflammatory or metabolic disorder that could lead to secondary osteoarthritis,
• administration of intra-articular knee injections within the past year,
• use of NSAIDs, paracetamol or topical agents within the preceding week,
• a prior history of surgical intervention involving the knee joint.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	baseline after treatment and at 3rd month	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.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	baseline after treatment and at 3rd month	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.
Short Form-36 (SF-36)	baseline after treatment and at 3rd month	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).
Timed Up & Go Test (TUG)	baseline after treatment and at 3rd month	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.

Trial Locations

Locations (1)

Istanbul Medeniyet University Goztepe Prof Dr Suleyman Yalcin City Hospital; 🇹🇷 Istanbul, None Selected, Turkey