Effectiveness of Radial Extracorporeal Shock Wave Therapy in Patients With Knee Osteoarthritis

NCT06281444 | Completed

• 1 other identifier: i01-30-24
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritis; Extracorporeal shock wave therapy (ESWT); Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 24 weeks

Secondary Outcomes (3)

• Change from baseline in functionality and walking distance

  Up to 24 weeks

• Change from baseline in walking distance

  Up to 24 weeks

• Patient Global Assesment (PGA) [by using the VAS]

  Up to 24 weeks

Study Arms (2)

ESWT group

ACTIVE COMPARATOR

The participants in this group will be applied with ESWT plus a home-based exercise program.

Device: ESWT

Sham-ESWT group

SHAM COMPARATOR

The participants in this group will be applied with sham-ESWT plus a home-based exercise program.

Device: Sham-ESWT

Interventions

ESWT DEVICE

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.

ESWT group

Sham-ESWT DEVICE

Sham ESWT application will be set to 1000 pulses, 2-3 bar pressure, 10 Hz frequency and 0 mJ/mm2 energy to be sham.

Sham-ESWT group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)
• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University

Ankara, Altındağ, 06230, Turkey (Türkiye)

Location

Related Publications (11)

• 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.

  PMID: 14703001 BACKGROUND

• Driban 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.

  PMID: 32471412 BACKGROUND

• Altman 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.

  PMID: 3741515 BACKGROUND

• Nelson 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.

  PMID: 24387819 BACKGROUND

• Haupt 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.

  PMID: 9186313 BACKGROUND

• Sems 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.

  PMID: 16585361 BACKGROUND

• Wang CJ. Extracorporeal shockwave therapy in musculoskeletal disorders. J Orthop Surg Res. 2012 Mar 20;7:11. doi: 10.1186/1749-799X-7-11.

  PMID: 22433113 BACKGROUND

• Wang 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.

  PMID: 23472862 BACKGROUND

• Zhao 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.

  PMID: 23953895 BACKGROUND

• Lee 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.

  PMID: 29201822 BACKGROUND

• Zhong 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.

  PMID: 31194946 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Birkan Sonel Tur, Prof

  Ankara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients who meet the study conditions and agree to participate in this study will not know whether they are in the first group or the second group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor (Physical Medicine and Rehabilitation)

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 28, 2024
• Study Start: January 1, 2024
• Primary Completion: September 15, 2025
• Study Completion: November 1, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)