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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06281444
• Other study ID #: i07-453-23
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: February 2024
• Source: Ankara University
• Contact: Sonel Tur
• Phone: +903125956331
• Email: sonelb[@]medicine.ankara.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and 6-minute walking test.

VAS is widely used in the assessment of pain. 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.

6 minutes walking test 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 third, sixth and twelfth months 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 0.90, the sample study is 36 patients per group and a total of 72 patients in total was found to be sufficient.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: July 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Patients with hip and/or ankle pathology

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Turkey	Ankara University	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to 24 weeks
Secondary	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.	Up to 24 weeks