Shockwave therapy plus strengthening exercises for knee osteoarthritis
Efficacy of Shock Wave Treatment to Reduce Pain and Improve Functionality in Patients With Knee Osteoarthritis: Randomized Clinical Trial.
This will see if adding one weekly shockwave session to a three-week knee strengthening program reduces pain and improves function for people with grade 2–3 knee osteoarthritis who have had VAS pain ≥4.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Guadarrama Hospital Academic / other |
| Locations | 2 sites (Guadarrama, Madrid and 1 other locations) |
| Trial ID | NCT07125430 on ClinicalTrials.gov |
What this trial studies
This is a randomized, controlled trial with allocation concealment comparing two groups: a three-week knee strengthening exercise program alone versus the same exercise program plus one weekly shockwave therapy session. Participants are recruited from the functional recovery unit at Guadarrama Hospital and randomized before starting rehabilitation. Pain (VAS) is the primary outcome and function is measured with the WOMAC questionnaire; assessments occur at baseline, end of the three-week treatment, one month, and three months after treatment. Clinical data are coded for confidentiality and analyzed to compare pain, stiffness, function, and patient satisfaction between groups.
Who should consider this trial
Good fit: Adults with symptomatic knee osteoarthritis (Kellgren‑Lawrence grade 2–3) who have had moderate-to-severe pain (VAS ≥4) in the past three months and can participate in a three-week rehabilitation program.
Not a fit: People with a recent stroke, knee surgery or intra-articular injection in the last three months, secondary knee osteoarthritis, or chronic inflammatory joint disease (and those with milder or end‑stage OA) are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, adding shockwave therapy could provide greater pain relief and improved knee function lasting up to three months compared with exercises alone.
How similar studies have performed: Smaller trials and preclinical work have suggested beneficial and chondroprotective effects of shockwave therapy in knee OA, but larger randomized trials are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Guadarrama, Madrid and 1 other locations
- Guadarrama Hospital — Guadarrama, Madrid, Spain (Recruiting)
- Hospital Guadarrama — Madrid, Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Yunia H Labrada Rodríguez, MD, MSc — Guadarrama Hospital
- Study coordinator: Yunia H Labrada Rodríguez, MD, MSc
- Email: yuniaherbania.labrada@salud.madrid.org
- Phone: +0034918562000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.