Shock Wave Treatment in Patients With Knee Osteoarthritis

NCT07125430 | Recruiting

• 1 other identifier: Código H.U.P.H.: PI 119/25
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

Introduction: Knee osteoarthritis represents a significant health problem due to its impact on the functionality and quality of life of patients. Its treatment can be pharmacological, non-pharmacological, or surgical. Recently, the chondroprotective potential of shockwave therapy has been evidenced. 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.

Conditions

Knee Osteoarthritis

Keywords

shock waves, knee osteoarthritis, rehabilitation

Outcome Measures

Primary Outcomes (1)

• Compare the magnitude of pain reduction between patients with knee osteoarthritis treated with shockwave therapy plus strengthening exercises and those treated only with strengthening exercises

  To assess pain, the validated Visual Analog Scale (VAS) will be used. This scale represents pain intensity on a 10 cm horizontal line, where 0 corresponds to "no pain" and 10 to "the worst pain imaginable." The scores will be interpreted as follows: a score below 4 indicates mild or mild-to-moderate pain; a score between 4 and 6 suggests moderate to severe pain; and a score above 6 reflects the presence of intense or very severe pain.

  From inclusion in the study until three months after the last treatment session

Secondary Outcomes (3)

• To examine difference in knee functionality improvement between both treatment groups

  From inclusion in the study until three months after the last treatment session.

• To evaluate the difference in degree of disability

  From inclusion in the study until three months after the last treatment session.

• Analyze the level of patient satisfaction with the outcomes obtained from each therapeutic modality.

  From inclusion in the study until three months after the last treatment session

Study Arms (2)

control group

ACTIVE COMPARATOR

In the control group, a strengthening exercise program will be carried out for three weeks.

Other: strengthening exercise

intervention group

ACTIVE COMPARATOR

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).

Other: strengthening exercise; Other: shock wave

Interventions

shock wave OTHER

3 sessions of shock wave therapy, frequency of one session per week

intervention group

strengthening exercise OTHER

a strengthening exercise program will be carried out for three weeks

control group; intervention group

Eligibility Criteria

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

You may qualify if:

• Knee pain assessed according to the VAS scale, with a score equal to or greater than 4 in the last 3 months.
• Osteoarthritis grade 2 or 3 in the Kellgren-Lawrence classification.
• Informed consent signature

You may not qualify if:

• Stroke in the last 3 months, knee surgery in the last 3 months, intra-articular infiltration in the last 3 months, secondary knee osteoarthritis, chronic inflammatory disease

Sponsors & Collaborators

• Guadarrama Hospital: lead

Study Sites (2)

Guadarrama Hospital

Guadarrama, Madrid, 28440, Spain

RECRUITING

Hospital Guadarrama

Madrid, Madrid, 28440, Spain

RECRUITING

Related Publications (13)

• 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.

  PMID: 28367081 BACKGROUND

• 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.

  PMID: 35203516 BACKGROUND

• 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.

  PMID: 32798759 BACKGROUND

• 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.

  PMID: 14554209 BACKGROUND

• 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.

  PMID: 15183445 BACKGROUND

• 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.

  PMID: 19916698 BACKGROUND

• 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.

  PMID: 21372687 BACKGROUND

• 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.

  PMID: 32215674 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 29406349 BACKGROUND

• 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.

  PMID: 33074309 BACKGROUND

• 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.

  PMID: 39274389 BACKGROUND

• 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.

  PMID: 35203417 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Yunia H Labrada Rodríguez, MD, MSc

  Guadarrama Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunia H Labrada Rodríguez, MD, MSc

CONTACT

+0034918562000; yuniaherbania.labrada@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 15, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 3, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)