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

NCT ID: NCT06717633

Last Updated: 2024-12-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-03-30

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.

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control

Control group only receives a daily exercise program, including knee joint range of motion, stretching, and strengthening exercises.

Group Type: NO_INTERVENTION

No interventions assigned to this group

ESWT

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

Group Type: EXPERIMENTAL

extracorporeal shock wave therapy

Intervention Type: DEVICE

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

LLLT

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.

Group Type: EXPERIMENTAL

low-level laser therapy

Intervention Type: DEVICE

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.

PEMF

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.

Group Type: EXPERIMENTAL

pulsed electromagnetic field therapy

Intervention Type: DEVICE

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.

Interventions

extracorporeal shock wave therapy

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

Intervention Type: DEVICE

low-level laser therapy

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.

Intervention Type: DEVICE

pulsed electromagnetic field therapy

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medeniyet University

OTHER

Sponsor Role: lead

Responsible Party

Bilinç Doğruöz Karatekin

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul Medeniyet University Goztepe Prof Dr Suleyman Yalcin City Hospital

Istanbul, None Selected, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

modalities

Identifier Type: -

Identifier Source: org_study_id