Knee OsteoarthritisNCT06281444
Effectiveness of Radial Extracorporeal Shock Wave Therapy in Patients With Knee Osteoarthritis
A study testing ESWT in people with Knee Osteoarthritis, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Osteoarthritis (OA) is a degenerative joint disease characterized by unsuccessful repair of joint damage resulting from stresses in any of the synovial joint tissues. Symptoms include pain (initially only after movement), joint stiffness, limitation of joint movement, feeling of insecurity in the joint, and difficulty… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- ESWT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Nov 2025
- Phase
- Interventional
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being over 50-85 years old.
- Diagnosis of knee osteoarthritis according to ACR clinical/radiological diagnostic criteria
- Stage 2 and above according to Kellgren Lawrence (K-L)
- Completion of Informed Signed Consent Form
Who cannot join
- Gait disorders due to orthopedic or neuromuscular disease
- Participation in a structured physical rehabilitation program in the last 12 months before the study
- Those who have had an intra-articular injection of the knee in the last 6 months
- History of lower extremity surgery
- Those with mechanical instability in the knee, a history of infection, malignancy
- Inflammatory rheumatic diseases (rheumatoid arthritis, spondyloarthritis etc.)
Show all 11Show fewer
- A medical diagnosis or self-reported cognitive impairment
- Presence of progressive cancer AND/OR other diseases that impair general condition
- Situations where ESWT application is contraindicated
- Having previously received ESWT treatment
- Patients with hip and/or ankle pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Effect of Radial Extracorporeal Shock Wave Therapy in Addition to Exercise on Pain, Functionality and Walking Distance in Patients With Knee Osteoarthritis: A Randomized Controlled Trial
Osteoarthritis (OA) is a degenerative joint disease characterized by unsuccessful repair of joint damage resulting from stresses in any of the synovial joint tissues. Symptoms include pain (initially only after movement), joint stiffness, limitation of joint movement, feeling of insecurity in the joint, and difficulty walking. The diagnosis of knee osteoarthritis can be easily made with a detailed history and a comprehensive physical examination. Radiographic examinations are used to support clinical findings and exclude other possible pathologies. The main purpose of treating knee osteoarthritis is to reduce pain and make daily life easier. Since there is no standard treatment method, the patient's treatment must be individualized by taking into account age, comorbidity, severity of the clinical picture, patient preferences and cost of treatment. Conservative treatment includes pharmacological and non-pharmacological treatment, and the optimal treatment should be applied as a combination of these two methods. Patient education, lifestyle modification, exercise, different physical therapy modalities (TENS, Interferential current, ESWT...), acupuncture are some non-pharmacological methods.
Extracorporeal shock wave therapy (ESWT), which is considered within the scope of conservative treatment, started in the seventies with the practice of breaking ureteric stones and has become one of the physical therapy modalities used in the treatment of various musculoskeletal diseases. Considering the historical development of ESWT, it has started to be used as a therapeutic modality in the treatment of knee osteoarthritis in recent years. The process, which started with animal experiments, continued with human studies, and evidence is presented that ESWT reduces knee pain and contributes to functionality. It is noteworthy that there are few studies and their short follow-up periods. In the light of these studies, it was planned to investigate the effectiveness of ESWT treatment, which will be applied together with exercise, on pain, functionality and walking distance in individuals diagnosed with knee osteoarthritis, in comparison with the control group receiving sham ESWT.
Read the detailed description
The study was planned as a randomized controlled trial. Eligible patients who meet the inclusion criteria, will be invited to the study.
Patients who accepted to participate in the study by meeting the criteria will be randomly divided into two groups as the first group treatment ESWT + exercise, the second group sham ESWT + exercise. Computer-aided software will be used to assign patients to treatment groups.
The following evaluations will be made: Visual Analog Scale (VAS), Patient Global Assessment (PGA), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and 6-minute walk test (6MWT).
VAS is widely used in the assessment of pain. In the present study, pain was assessed in three conditions: at rest, during movement, and at night.
PGA is an instrument used in clinical settings to capture the patient's subjective appraisal of overall health and disease-related well-being, serving as a concise indicator of disease activity.
WOMAC is widely used to evaluate the functional status of patients with knee osteoarthritis. High WOMAC values indicate increased pain and stiffness/stiffness, and impaired physical function.
6MWT will be done by the physician in the marked corridor of 30 meters in our clinic. At the end of 6 minutes, the total distance they walked will be determined and recorded in meters.
The exercises to be applied to each group are knee range of motion and strengthening exercises for the knee. It will be checked by phone on a weekly basis.
The first group will receive ESWT and exercise therapy. ESWT application will be given to the medial part of the knee region on the side where the pain is described, on the patellofemoral and tibiofemoral joint lines and once a week in a total of four sessions.
The second group will receive sham ESWT and exercise therapy. Sham ESWT application will be given to the medial part of the knee region on the side where the pain is described, on the patellofemoral and tibiofemoral joint lines and once a week in a total of four sessions.
Before starting the 4-session treatment program, at the end of the treatment program and at the twelfth, twenty-fourth weeks from the beginning of the treatment, the scales and tests under the heading of evaluations will be administered.
The sample calculation was made on the effect size. When the effect size of the difference between the two treatment groups in terms of change in VAS is taken as 0.8, when the sample is calculated using the Mann-Whitney U test with a significance level of 0.05 and a power of 0.85, the sample study is 36 patients per group and a total of 72 patients in total was found to be sufficient.
- Conditions
- Knee Osteoarthritis
- Being tested
- ESWT, Sham-ESWT
- Keywords
- Knee osteoarthritis, Extracorporeal shock wave therapy (ESWT), Pain
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESWTDevice
All patients in both groups will be applied with a home-based exercise program around for 30-minutes per day for four weeks. The exercises that mentioned in the research content are knee range of motion and strengthening exercises for the knee. It will be checked by phone on a weekly basis. Also, each patient in group 1 will receive shockwaves of continuous frequency and intensity (1000 shocks, 2.0 to 3.0 bar,10 Hz and 0.08-0.25mJ/mm2 energy range), while the second group of patients will receive sham-ESWT.
ESWT application will be applied to the medial part of the knee area on the side where the pain is described, or at the patellofemoral and tibiofemoral borders of the affected knee, and will be given in four sessions in total once a week.
Sham-ESWTDevice
Sham ESWT application will be set to 1000 pulses, 2-3 bar pressure, 10 Hz frequency and 0 mJ/mm2 energy to be sham.
| Study group | Role | What they receive |
|---|---|---|
| ESWT group | Active comparator | The participants in this group will be applied with ESWT plus a home-based exercise program. Receives: Device: ESWT |
| Sham-ESWT group | Sham comparator | The participants in this group will be applied with sham-ESWT plus a home-based exercise program. Receives: Device: Sham-ESWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain [by using the Visual Analogue Scale(VAS)]
It was defined as the change in pain (VAS) felt after 4 sessions of ESWT treatment from baseline.
Visual Analog Scale (VAS): Vas is widely used in pain assessment. The numbers 0 and 10 are written at both ends of a 10 cm line. 0 = I have no pain 10 = means I have unbearable pain. The pain level increases from 0 to 10. The patient is asked to indicate which point on this chart is most appropriate for his/her situation. The location marked by the patient will be evaluated by measuring its distance from point 0.
Measured: Up to 24 weeks
Secondary outcomes (3)
Change from baseline in functionality and walking distance
Change from baseline in functionality (WOMAC) and walking distance (6-minute walk test)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): WOMAC is widely used to evaluate the functionality status in patients with knee osteoarthritis.
High WOMAC values indicate increased pain and stiffness and deterioration in physical function.
The form consists of three subheadings (pain, stiffness, physical function) and 24 questions.
The pain subheading is questioned with 5 questions, and the stiffness subheading is questioned with 2 questions. In the physical function evaluation, 17 activities are questioned.
Scoring of the items is done according to the Likert scale. The degree of pain and strain is indicated by giving points from 0 to 4 on the Likert scale.
Measured: Up to 24 weeks
Change from baseline in walking distance
Change from baseline in walking distance (6-minute walk test)
6-minute walk test: It will be performed by the physician in the 30-meter marked corridor in our clinic. Patients will be asked to rest for at least 10 minutes before starting the test.
Patients will be asked to walk as far as they can in the corridor for 6 minutes at their own pace.
At the end of 6 minutes, the total distance walked will be determined and recorded in meters.
Measured: Up to 24 weeks
Patient Global Assesment (PGA) [by using the VAS]
It was defined as the change in PGA felt after 4 sessions of ESWT treatment from baseline.
The Patient Global Assessment (PGA) is a measure used in clinical research and routine practice to capture the patient's subjective evaluation of their overall health status and disease-related well-being, serving as an integrative indicator of disease activity.
The numbers 0 and 10 are written at both ends of a 10 cm line. 0 = very much worse 10 = much better The PGA level increases from 0 to 10. The patient is asked to indicate which point on this chart is most appropriate for his/her situation. The location marked by the patient will be evaluated by measuring its distance from point 0.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Jan 2024
- Primary completion15 Sep 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients who accepted to participate in the study by meeting the criteria will be randomly divided into two groups as the first group treatment ESWT + exercise, the second group sham ESWT + exercise.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birkan Sonel Tur, Ankara University
- Investigators
- Birkan Sonel Tur, Prof, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281444
- Sponsor's protocol ID
- i01-30-24
- Status last verified
- Nov 2025
- First submitted
- 7 Feb 2024
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Corti MC, Rigon C. Epidemiology of osteoarthritis: prevalence, risk factors and functional impact. Aging Clin Exp Res. 2003 Oct;15(5):359-63. doi: 10.1007/BF03327356.
PubMed 14703001Driban JB, Harkey MS, Barbe MF, Ward RJ, MacKay JW, Davis JE, Lu B, Price LL, Eaton CB, Lo GH, McAlindon TE. Risk factors and the natural history of accelerated knee osteoarthritis: a narrative review. BMC Musculoskelet Disord. 2020 May 29;21(1):332. doi: 10.1186/s12891-020-03367-2.
PubMed 32471412Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.
PubMed 3741515Nelson AE, Allen KD, Golightly YM, Goode AP, Jordan JM. A systematic review of recommendations and guidelines for the management of osteoarthritis: The chronic osteoarthritis management initiative of the U.S. bone and joint initiative. Semin Arthritis Rheum. 2014 Jun;43(6):701-12. doi: 10.1016/j.semarthrit.2013.11.012. Epub 2013 Dec 4.
PubMed 24387819Haupt G. Use of extracorporeal shock waves in the treatment of pseudarthrosis, tendinopathy and other orthopedic diseases. J Urol. 1997 Jul;158(1):4-11. doi: 10.1097/00005392-199707000-00003.
PubMed 9186313Sems A, Dimeff R, Iannotti JP. Extracorporeal shock wave therapy in the treatment of chronic tendinopathies. J Am Acad Orthop Surg. 2006 Apr;14(4):195-204. doi: 10.5435/00124635-200604000-00001.
PubMed 16585361Wang CJ. Extracorporeal shockwave therapy in musculoskeletal disorders. J Orthop Surg Res. 2012 Mar 20;7:11. doi: 10.1186/1749-799X-7-11.
PubMed 22433113Wang CJ, Sun YC, Siu KK, Wu CT. Extracorporeal shockwave therapy shows site-specific effects in osteoarthritis of the knee in rats. J Surg Res. 2013 Aug;183(2):612-9. doi: 10.1016/j.jss.2013.02.006. Epub 2013 Feb 26.
PubMed 23472862Zhao Z, Jing R, Shi Z, Zhao B, Ai Q, Xing G. Efficacy of extracorporeal shockwave therapy for knee osteoarthritis: a randomized controlled trial. J Surg Res. 2013 Dec;185(2):661-6. doi: 10.1016/j.jss.2013.07.004. Epub 2013 Jul 30.
PubMed 23953895Lee JK, Lee BY, Shin WY, An MJ, Jung KI, Yoon SR. Effect of Extracorporeal Shockwave Therapy Versus Intra-articular Injections of Hyaluronic Acid for the Treatment of Knee Osteoarthritis. Ann Rehabil Med. 2017 Oct;41(5):828-835. doi: 10.5535/arm.2017.41.5.828. Epub 2017 Oct 31.
PubMed 29201822Zhong Z, Liu B, Liu G, Chen J, Li Y, Chen J, Liu X, Hu Y. A Randomized Controlled Trial on the Effects of Low-Dose Extracorporeal Shockwave Therapy in Patients With Knee Osteoarthritis. Arch Phys Med Rehabil. 2019 Sep;100(9):1695-1702. doi: 10.1016/j.apmr.2019.04.020. Epub 2019 Jun 10.
PubMed 31194946
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Effect of Radial Extracorporeal Shock Wave Therapy in Addition to Exercise on Pain, Functionality and Walking Distance in Patients With Knee Osteoarthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06281444
- Acronym / sponsor ID
- i01-30-24
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee osteoarthritis, Extracorporeal shock wave therapy (ESWT), Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 28 Feb 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.
Osteoarthritis (OA) is a degenerative joint disease characterized by unsuccessful repair of joint damage resulting from stresses in any of the synovial joint tissues. Symptoms include pain (initially only after movement), joint stiffness, limitation of joint movement, feeling of insecurity in the joint, and difficulty walking. The diagnosis of knee osteoarthritis can be easily made with a detailed history and a comprehensive physical examination. Radiographic examinations are used to support clinical findings and exclude other possible pathologies. The main purpose of treating knee osteoarthritis is to reduce pain and make daily life easier. Since there is no standard treatment method, the patient's treatment must be individualized by taking into account age, comorbidity, severity of the clinical picture, patient preferences and cost of treatment. Conservative treatment includes pharmacological and non-pharmacological treatment, and the optimal treatment should be applied as a combination of these two methods. Patient education, lifestyle modification, exercise, different physical therapy modalities (TENS, Interferential current, ESWT...), acupuncture are some non-pharmacological methods.
Extracorporeal shock wave therapy (ESWT), which is considered within the scope of conservative treatment, started in the seventies with the practice of breaking ureteric stones and has become one of the physical therapy modalities used in the treatment of various musculoskeletal diseases. Considering the historical development of ESWT, it has started to be used as a therapeutic modality in the treatment of knee osteoarthritis in recent years. The process, which started with animal experiments, continued with human studies, and evidence is presented that ESWT reduces knee pain and contributes to functionality. It is noteworthy that there are few studies and their short follow-up periods. In the light of these studies, it was planned to investigate the effectiveness of ESWT treatment, which will be applied together with exercise, on pain, functionality and walking distance in individuals diagnosed with knee osteoarthritis, in comparison with the control group receiving sham ESWT.
Detailed description
The study was planned as a randomized controlled trial. Eligible patients who meet the inclusion criteria, will be invited to the study.
Patients who accepted to participate in the study by meeting the criteria will be randomly divided into two groups as the first group treatment ESWT + exercise, the second group sham ESWT + exercise. Computer-aided software will be used to assign patients to treatment groups.
The following evaluations will be made: Visual Analog Scale (VAS), Patient Global Assessment (PGA), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and 6-minute walk test (6MWT).
VAS is widely used in the assessment of pain. In the present study, pain was assessed in three conditions: at rest, during movement, and at night.
PGA is an instrument used in clinical settings to capture the patient's subjective appraisal of overall health and disease-related well-being, serving as a concise indicator of disease activity.
WOMAC is widely used to evaluate the functional status of patients with knee osteoarthritis. High WOMAC values indicate increased pain and stiffness/stiffness, and impaired physical function.
6MWT will be done by the physician in the marked corridor of 30 meters in our clinic. At the end of 6 minutes, the total distance they walked will be determined and recorded in meters.
The exercises to be applied to each group are knee range of motion and strengthening exercises for the knee. It will be checked by phone on a weekly basis.
The first group will receive ESWT and exercise therapy. ESWT application will be given to the medial part of the knee region on the side where the pain is described, on the patellofemoral and tibiofemoral joint lines and once a week in a total of four sessions.
The second group will receive sham ESWT and exercise therapy. Sham ESWT application will be given to the medial part of the knee region on the side where the pain is described, on the patellofemoral and tibiofemoral joint lines and once a week in a total of four sessions.
Before starting the 4-session treatment program, at the end of the treatment program and at the twelfth, twenty-fourth weeks from the beginning of the treatment, the scales and tests under the heading of evaluations will be administered.
The sample calculation was made on the effect size. When the effect size of the difference between the two treatment groups in terms of change in VAS is taken as 0.8, when the sample is calculated using the Mann-Whitney U test with a significance level of 0.05 and a power of 0.85, the sample study is 36 patients per group and a total of 72 patients in total was found to be sufficient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients who accepted to participate in the study by meeting the criteria will be randomly divided into two groups as the first group treatment ESWT + exercise, the second group sham ESWT + exercise.
| Arm | Type | Receives |
|---|---|---|
| ESWT group | Active comparator | Device: ESWTThe participants in this group will be applied with ESWT plus a home-based exercise program. |
| Sham-ESWT group | Sham comparator | Device: Sham-ESWTThe participants in this group will be applied with sham-ESWT plus a home-based exercise program. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being over 50-85 years old.
- Diagnosis of knee osteoarthritis according to ACR clinical/radiological diagnostic criteria
- Stage 2 and above according to Kellgren Lawrence (K-L)
- Completion of Informed Signed Consent Form
Key exclusion criteria (11 listed)
- Gait disorders due to orthopedic or neuromuscular disease
- Participation in a structured physical rehabilitation program in the last 12 months before the study
- Those who have had an intra-articular injection of the knee in the last 6 months
- History of lower extremity surgery
- Those with mechanical instability in the knee, a history of infection, malignancy
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 |
|---|---|---|
| ESWTAll patients in both groups will be applied with a home-based exercise program around for 30-minutes per day for four weeks. The exercises that mentioned in the research content are knee range of motion and strengthening exercises for the knee. It will be checked by phone on a weekly basis. Also, each patient in group 1 will receive shockwaves of continuous frequency and intensity (1000 shocks, 2.0 to 3.0 bar,10 Hz and 0.08-0.25mJ/mm2 energy range), while the second group of patients will receive sham-ESWT. ESWT application will be applied to the medial part of the knee area on the side where the pain is described, or at the patellofemoral and tibiofemoral borders of the affected knee, and will be given in four sessions in total once a week. | Device | ESWT group |
| Sham-ESWTSham ESWT application will be set to 1000 pulses, 2-3 bar pressure, 10 Hz frequency and 0 mJ/mm2 energy to be sham. | Device | Sham-ESWT group |
Primary outcome
Change in pain [by using the Visual Analogue Scale(VAS)]
Time frame: Up to 24 weeks
It was defined as the change in pain (VAS) felt after 4 sessions of ESWT treatment from baseline. Visual Analog Scale (VAS): Vas is widely used in pain assessment. The numbers 0 and 10 are written at both ends of a 10 cm line. 0 = I have no pain 10 = means I have unbearable pain. The pain level increases from 0 to 10. The patient is asked to indicate which point on this chart is most appropriate for his/her situation. The location marked by the patient will be evaluated by measuring its distance from point 0.
3 secondary outcomes
Change from baseline in functionality and walking distance
Time frame: Up to 24 weeks
Change from baseline in walking distance
Time frame: Up to 24 weeks
Patient Global Assesment (PGA) [by using the VAS]
Time frame: Up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Background: PubMed 14703001Corti MC, Rigon C. Epidemiology of osteoarthritis: prevalence, risk factors and functional impact. Aging Clin Exp Res. 2003 Oct;15(5):359-63. doi: 10.1007/BF03327356.
- Background: PubMed 32471412Driban JB, Harkey MS, Barbe MF, Ward RJ, MacKay JW, Davis JE, Lu B, Price LL, Eaton CB, Lo GH, McAlindon TE. Risk factors and the natural history of accelerated knee osteoarthritis: a narrative review. BMC Musculoskelet Disord. 2020 May 29;21(1):332. doi: 10.1186/s12891-020-03367-2.
- Background: PubMed 3741515Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.
- Background: PubMed 24387819Nelson AE, Allen KD, Golightly YM, Goode AP, Jordan JM. A systematic review of recommendations and guidelines for the management of osteoarthritis: The chronic osteoarthritis management initiative of the U.S. bone and joint initiative. Semin Arthritis Rheum. 2014 Jun;43(6):701-12. doi: 10.1016/j.semarthrit.2013.11.012. Epub 2013 Dec 4.
- Background: PubMed 9186313Haupt G. Use of extracorporeal shock waves in the treatment of pseudarthrosis, tendinopathy and other orthopedic diseases. J Urol. 1997 Jul;158(1):4-11. doi: 10.1097/00005392-199707000-00003.
- Background: PubMed 16585361Sems A, Dimeff R, Iannotti JP. Extracorporeal shock wave therapy in the treatment of chronic tendinopathies. J Am Acad Orthop Surg. 2006 Apr;14(4):195-204. doi: 10.5435/00124635-200604000-00001.
- Background: PubMed 22433113Wang CJ. Extracorporeal shockwave therapy in musculoskeletal disorders. J Orthop Surg Res. 2012 Mar 20;7:11. doi: 10.1186/1749-799X-7-11.
- Background: PubMed 23472862Wang CJ, Sun YC, Siu KK, Wu CT. Extracorporeal shockwave therapy shows site-specific effects in osteoarthritis of the knee in rats. J Surg Res. 2013 Aug;183(2):612-9. doi: 10.1016/j.jss.2013.02.006. Epub 2013 Feb 26.
- Background: PubMed 23953895Zhao Z, Jing R, Shi Z, Zhao B, Ai Q, Xing G. Efficacy of extracorporeal shockwave therapy for knee osteoarthritis: a randomized controlled trial. J Surg Res. 2013 Dec;185(2):661-6. doi: 10.1016/j.jss.2013.07.004. Epub 2013 Jul 30.
- Background: PubMed 29201822Lee JK, Lee BY, Shin WY, An MJ, Jung KI, Yoon SR. Effect of Extracorporeal Shockwave Therapy Versus Intra-articular Injections of Hyaluronic Acid for the Treatment of Knee Osteoarthritis. Ann Rehabil Med. 2017 Oct;41(5):828-835. doi: 10.5535/arm.2017.41.5.828. Epub 2017 Oct 31.
- Background: PubMed 31194946Zhong Z, Liu B, Liu G, Chen J, Li Y, Chen J, Liu X, Hu Y. A Randomized Controlled Trial on the Effects of Low-Dose Extracorporeal Shockwave Therapy in Patients With Knee Osteoarthritis. Arch Phys Med Rehabil. 2019 Sep;100(9):1695-1702. doi: 10.1016/j.apmr.2019.04.020. Epub 2019 Jun 10.
- 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.
Birkan Sonel Tur, Prof principal investigator
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESWT in people with Knee Osteoarthritis, run by Ankara 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 4 inclusion and 11 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: finished, as of the sponsor's last update on 1 Dec 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in pain [by using the Visual Analogue Scale(VAS)] (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06281444, which also lists 11 linked publications.
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 1 Dec 2025.