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Not yet recruiting NCT07567365

Clinical Outcomes of Focused Shockwave Therapy Without Adjunct Rehabilitation Compared to Standard Physical Rehabilitation in Patients With Grade I-III Knee Osteoarthritis: A Single-Blind Randomized Study

No phase Interventional Knee Osteoarthristis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Physical Rehab, Focused Shockwave Therapy.
Who it may be relevant to
Registry conditions: Knee Osteoarthristis. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Clinical Outcomes of Focused Shockwave Therapy Without Adjunct Rehabilitation Compared to Standard Physical Rehabilitation in Patients with Grade I-III Knee Osteoarthritis: A Single-Blind Randomized Study

Interventions

  • Other Physical Rehab
    Physical rehab through the use of body weight exercises, resistance bands, weights, movement, repetitive movement.
  • Device Focused Shockwave Therapy
    Applying focused shockwave therapy using a focused shockwave therapy device to the treatment area.

Primary outcome measures

  • Change in WOMAC Pain Subscale score from baseline to the primary endpoint - likely 8 or 12 weeks after treatment begins. [Time frame: 8 to 12 weeks]

Eligibility criteria

Inclusion criteria

  • Patient must have diagnosed OA of the unilateral or bilateral knee(s) sufficient to qualify as grade I, II, or III O.A.

Exclusion criteria

  • Patients without diagnosable or gradable O.A. of the knee or knees.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Westminster Spine & Injury Center — Westminster

Publications

  • 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
  • Covelli I, De Giorgi S, Di Lorenzo A, Pavone A, Salvato F, Rifino F, Moretti B, Solarino G, Notarnicola A. Extracorporeal Shock Wave Therapy (ESWT) vs. Exercise in Thumb Osteoarthritis (SWEX-TO): Prospective Clinical Trial at 6 Months. Life (Basel). 2024 Nov 8;14(11):1453. doi: 10.3390/life14111453. PMID 39598251
  • Liao PC, Chou SH, Shih CL. A systematic review of the use of shockwave therapy for knee osteoarthritis. J Orthop. 2024 May 1;56:18-25. doi: 10.1016/j.jor.2024.04.020. eCollection 2024 Oct. PMID 38765896
  • 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

Identifiers

NCT: NCT07567365 · IKOABS1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗