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Knee OsteoarthritisSWKONCT07125430

Shock Wave Treatment in Patients With Knee Osteoarthritis

A study testing strengthening exercise and shock wave in people with Knee Osteoarthritis, run by Guadarrama Hospital at 2 sites in Spain.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Knee Osteoarthritis
What is being tested?
strengthening exercise and shock wave
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesSpain
Study dates
30 Jul 2026to 30 Dec 2027
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Spain2 sites
  • Guadarrama Hospital

    Guadarrama, Madrid, 28440

  • Hospital Guadarrama

    Madrid, Madrid, 28440

Other trials in Spain

About this study

Official title: Efficacy of Shock Wave Treatment to Reduce Pain and Improve Functionality in Patients With Knee Osteoarthritis: Randomized Clinical Trial.

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.

Read more

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.

Read the detailed description

The research team will recruit participants who meet inclusion criteria and do not present exclusion criteria during their admission to the functional recovery unit. A team member will inform and invite the subject to participate in the study. The Patient Information Sheet will be provided to them. Patients who decide to participate will need to sign the Informed Consent. At that moment, they will be scheduled to begin rehabilitation according to the protocol proposed for the study. Before starting treatment, patients will be randomized into treatment groups: shockwave treatment combined with knee strengthening exercises (intervention group) and treatment with knee strengthening exercises (control group).

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.

Being tested
strengthening exercise, shock wave
Keywords
shock waves, knee osteoarthritis, rehabilitation
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • strengthening exerciseOther

    a strengthening exercise program will be carried out for three weeks

  • shock waveOther

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

Study groups in NCT07125430
Study groupRoleWhat they receive
control groupActive comparatorIn the control group, a strengthening exercise program will be carried out for three weeks.
Receives: Other: strengthening exercise
intervention groupActive comparatorIn 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).
Receives: Other: strengthening exercise; Other: shock wave

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)
  1. To examine difference in knee functionality improvement between both treatment groups

    To assess functionality, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire will be used.

    WOMAC is a specific tool for assessing patients with hip and knee osteoarthritis. It consists of 24 items divided into three domains: pain, stiffness, and physical function. Higher scores indicate greater impairment. The scale will be used under license during the study.

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

  2. To evaluate the difference in degree of disability

    Lequesne Index includes aspects related to pain, walking ability, and daily activities, providing a total score from 0 to 24 points, with higher scores indicating greater impairment. The scale will be used under license during the study.

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

  3. Overall assessment of the treatment outcome by the patient.

    Roles and Maudsley score: it will be used to carry out an overall assessment of the treatment outcome by the patient, using a four-level categorical scale: excellent, good, fair, and poor. The scale will be used under license during the study

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2025
  2. Study start30 Jul 2026 (estimated)
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Why it stopped: The study was withdrawn before recruitment due to organizational changes.

Resources

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
Randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07125430
Sponsor's protocol ID
Código H.U.P.H.: PI 119/25
Acronym
SWKO
Status last verified
Sep 2026
First submitted
8 Aug 2025
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Roles NC, Maudsley RH. Radial tunnel syndrome: resistant tennis elbow as a nerve entrapment. J Bone Joint Surg Br. 1972 Aug;54(3):499-508. No abstract available.

    PubMed 4340924
  • Lequesne MG, Mery C, Samson M, Gerard P. Indexes of severity for osteoarthritis of the hip and knee. Validation--value in comparison with other assessment tests. Scand J Rheumatol Suppl. 1987;65:85-9. doi: 10.3109/03009748709102182.

    PubMed 3479839
  • Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.

    PubMed 3068365
  • 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.

    PubMed 35203516
  • 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.

    PubMed 32798759
  • 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.

    PubMed 14554209
  • 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.

    PubMed 15183445
  • 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.

    PubMed 19916698
  • 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.

    PubMed 21372687
  • 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.

    PubMed 32215674
  • 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.

    PubMed 29406349
  • 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.

    PubMed 33074309
  • 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.

    PubMed 39274389
  • 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.

    PubMed 35203417

Questions about this trial

What is this clinical trial studying?

A study testing strengthening exercise and shock wave in people with Knee Osteoarthritis, run by Guadarrama Hospital at 2 sites in Spain.

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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. 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. 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 was withdrawn before enrolling participants, so there are no results.

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?

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 (time frame: From inclusion in the study until three months after the last treatment session). 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 NCT07125430, which also lists 15 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 14 Sep 2026.

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