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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Guadarrama Hospital
RECRUITING
Guadarrama
Hospital Guadarrama
RECRUITING
Madrid
Contact Information
Primary
Yunia H Labrada Rodríguez, MD, MSc
yuniaherbania.labrada@salud.madrid.org
+0034918562000
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 40
Treatments
Active_comparator: control group
In the control group, a strengthening exercise program will be carried out for three weeks.
Active_comparator: 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).
Related Therapeutic Areas
Sponsors
Leads: Guadarrama Hospital

This content was sourced from clinicaltrials.gov