Shock Wave Treatment in Patients With Knee Osteoarthritis
NCT ID: NCT07125430
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2025-09-01
2026-12-01
Brief Summary
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Objective: To determine whether shockwave treatment combined with knee strengthening exercises is superior to knee strengthening exercises alone in reducing pain and improving function in patients with knee osteoarthritis.
Method: A randomized controlled trial with allocation concealment is proposed. Patients with knee pain secondary to knee osteoarthritis will participate during their hospital admission. Two groups will be formed: both will follow an exercise program for three weeks, and the intervention group will add a weekly shockwave session during that same period.
The main variable will be pain intensity; other variables include stiffness, functional capacity, degree of satisfaction, and data related to the application of therapy (frequency, intensity, number of pulses, side effects). Clinical data will also be collected such as reason for admission, age, sex, comorbidities, degree of dependency, walking ability, analgesia, use of assistive devices, and progress during treatment.
Applicability: The results could lead to a change in clinical practice, serving as a basis for modifying treatment protocols for knee osteoarthritis in medium-stay hospitals. Furthermore, they would provide additional scientific evidence on the efficacy of shock wave therapy for this condition.
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Detailed Description
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The Data Collection Notebook will be completed, which has been prepared by the research team. In order to ensure the confidentiality of clinical data, these will be coded by dissociating the identifying and personal data from those necessary for the configuration of variables. For this, the principal investigator will carry out a coding process of the units of analysis.
All study participants will be evaluated at four points in time: before starting rehabilitative treatment, at the end of the three weeks of treatment, one month after the last treatment session, and three months after the last treatment session. At these four points, pain will be assessed using the VAS scale and functionality will be assessed using the WOMAC questionnaire.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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control group
In the control group, a strengthening exercise program will be carried out for three weeks.
strengthening exercise
a strengthening exercise program will be carried out for three weeks
intervention group
In the intervention group, in addition to the strengthening exercise program, 3 sessions of shock wave therapy (PiezoWave 2 Control Unit, classification 93/42/EEC class IIb) will be conducted, at a frequency of one session per week.
The parameters for shock wave therapy will be: frequency 4-6 Hz, intensity 0.11-0.35 mJ/mm2, and number of pulses 2000 (applied to the femoral condyle and tibial plateau).
strengthening exercise
a strengthening exercise program will be carried out for three weeks
shock wave
3 sessions of shock wave therapy, frequency of one session per week
Interventions
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strengthening exercise
a strengthening exercise program will be carried out for three weeks
shock wave
3 sessions of shock wave therapy, frequency of one session per week
Eligibility Criteria
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Inclusion Criteria
* Osteoarthritis grade 2 or 3 in the Kellgren-Lawrence classification.
* Informed consent signature
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Guadarrama Hospital
OTHER
Responsible Party
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Principal Investigators
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Yunia H Labrada Rodríguez, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Guadarrama Hospital
Locations
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Guadarrama Hospital
Guadarrama, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Wang CJ, Cheng JH, Chou WY, Hsu SL, Chen JH, Huang CY. Changes of articular cartilage and subchondral bone after extracorporeal shockwave therapy in osteoarthritis of the knee. Int J Med Sci. 2017 Feb 23;14(3):213-223. doi: 10.7150/ijms.17469. eCollection 2017.
Liao CD, Huang YY, Chen HC, Liou TH, Lin CL, Huang SW. Relative Effect of Extracorporeal Shockwave Therapy Alone or in Combination with Noninjective Treatments on Pain and Physical Function in Knee Osteoarthritis: A Network Meta-Analysis of Randomized Controlled Trials. Biomedicines. 2022 Jan 28;10(2):306. doi: 10.3390/biomedicines10020306.
Avendano-Coy J, Comino-Suarez N, Grande-Munoz J, Avendano-Lopez C, Gomez-Soriano J. Extracorporeal shockwave therapy improves pain and function in subjects with knee osteoarthritis: A systematic review and meta-analysis of randomized clinical trials. Int J Surg. 2020 Oct;82:64-75. doi: 10.1016/j.ijsu.2020.07.055. Epub 2020 Aug 13.
Wang CJ, Wang FS, Yang KD, Weng LH, Hsu CC, Huang CS, Yang LC. Shock wave therapy induces neovascularization at the tendon-bone junction. A study in rabbits. J Orthop Res. 2003 Nov;21(6):984-9. doi: 10.1016/S0736-0266(03)00104-9.
Chen YJ, Wang CJ, Yang KD, Kuo YR, Huang HC, Huang YT, Sun YC, Wang FS. Extracorporeal shock waves promote healing of collagenase-induced Achilles tendinitis and increase TGF-beta1 and IGF-I expression. J Orthop Res. 2004 Jul;22(4):854-61. doi: 10.1016/j.orthres.2003.10.013.
Berta L, Fazzari A, Ficco AM, Enrica PM, Catalano MG, Frairia R. Extracorporeal shock waves enhance normal fibroblast proliferation in vitro and activate mRNA expression for TGF-beta1 and for collagen types I and III. Acta Orthop. 2009 Oct;80(5):612-7. doi: 10.3109/17453670903316793.
Mittermayr R, Hartinger J, Antonic V, Meinl A, Pfeifer S, Stojadinovic A, Schaden W, Redl H. Extracorporeal shock wave therapy (ESWT) minimizes ischemic tissue necrosis irrespective of application time and promotes tissue revascularization by stimulating angiogenesis. Ann Surg. 2011 May;253(5):1024-32. doi: 10.1097/SLA.0b013e3182121d6e.
Uysal A, Yildizgoren MT, Guler H, Turhanoglu AD. Effects of radial extracorporeal shock wave therapy on clinical variables and isokinetic performance in patients with knee osteoarthritis: a prospective, randomized, single-blind and controlled trial. Int Orthop. 2020 Jul;44(7):1311-1319. doi: 10.1007/s00264-020-04541-w. Epub 2020 Mar 26.
ESWT Guidelines English version Updated and agreed from the ISMST Managing Board, in close cooperation with the Germanspeaking Society for Extracorporeal Shockwave Therapy (DIGEST) Daegu, South Korea July 20th, 2023 .ISMST-Guidelines-for-ESWT-_-engl-20240103.pdf
Moya D, Ramon S, Schaden W, Wang CJ, Guiloff L, Cheng JH. The Role of Extracorporeal Shockwave Treatment in Musculoskeletal Disorders. J Bone Joint Surg Am. 2018 Feb 7;100(3):251-263. doi: 10.2106/JBJS.17.00661. No abstract available.
An S, Li J, Xie W, Yin N, Li Y, Hu Y. Extracorporeal shockwave treatment in knee osteoarthritis: therapeutic effects and possible mechanism. Biosci Rep. 2020 Nov 27;40(11):BSR20200926. doi: 10.1042/BSR20200926.
Giaretta S, Magni A, Migliore A, Natoli S, Puntillo F, Ronconi G, Santoiemma L, Sconza C, Viapiana O, Zanoli G. A Review of Current Approaches to Pain Management in Knee Osteoarthritis with a Focus on Italian Clinical Landscape. J Clin Med. 2024 Aug 31;13(17):5176. doi: 10.3390/jcm13175176.
Jhan SW, Wang CJ, Wu KT, Siu KK, Ko JY, Huang WC, Chou WY, Cheng JH. Comparison of Extracorporeal Shockwave Therapy with Non-Steroid Anti-Inflammatory Drugs and Intra-Articular Hyaluronic Acid Injection for Early Osteoarthritis of the Knees. Biomedicines. 2022 Jan 18;10(2):202. doi: 10.3390/biomedicines10020202.
Other Identifiers
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Código H.U.P.H.: PI 119/25
Identifier Type: -
Identifier Source: org_study_id
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