Knee OsteoarthritisPhase 3NCT06717633
Comparison of Short-term Effects of Extracorporeal Shock Wave Therapy, Low-level Laser Therapy and Pulsed Electromagnetic Field Therapy in Knee Osteoarthritis
A Phase 3 study testing extracorporeal shock wave therapy, low-level laser therapy and pulsed electromagnetic field therapy in people with Knee Osteoarthritis, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- extracorporeal shock wave therapy, low-level laser therapy and pulsed electromagnetic field therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 30 Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University Goztepe Prof Dr Suleyman Yalcin City Hospital
Istanbul, None Selected, 34722
About this study
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
- Being tested
- extracorporeal shock wave therapy, low-level laser therapy, pulsed electromagnetic field therapy
- Keywords
- knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extracorporeal shock wave therapyDevice
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
low-level laser therapyDevice
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.
pulsed electromagnetic field therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control group only receives a daily exercise program, including knee joint range of motion, stretching, and strengthening exercises. |
| ESWT | Experimental | 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 Receives: Device: extracorporeal shock wave therapy |
| LLLT | Experimental | 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. Receives: Device: low-level laser therapy |
| PEMF | Experimental | 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. Receives: Device: pulsed electromagnetic field therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: baseline after treatment and at 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Jan 2024
- Primary completion27 Jan 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilinç Doğruöz Karatekin, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717633
- Sponsor's protocol ID
- modalities
- Status last verified
- Jan 2024
- First submitted
- 30 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Short-term Effects of Extracorporeal Shock Wave Therapy, Low-level Laser Therapy and Pulsed Electromagnetic Field Therapy in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06717633
- Acronym / sponsor ID
- modalities
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 27 Jan 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control group only receives a daily exercise program, including knee joint range of motion, stretching, and strengthening exercises. |
| ESWT | Experimental | Device: extracorporeal shock wave therapyThe 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 | Experimental | Device: low-level laser therapyThe 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 | Experimental | Device: pulsed electromagnetic field therapyFor 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extracorporeal shock wave therapyThe 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 | Device | ESWT |
| low-level laser therapyThe 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. | Device | LLLT |
| pulsed electromagnetic field therapyFor 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. | Device | PEMF |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing extracorporeal shock wave therapy, low-level laser therapy and pulsed electromagnetic field therapy in people with Knee Osteoarthritis, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: baseline after treatment and at 3rd month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.