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Focused Extracorporeal Shockwave Therapy for Knee Arthritis
NCT05596591 · View on ClinicalTrials.gov ↗
Study Summary
Subchondral bone marrow lesions (BMLs) in knee osteoarthritis (OA) are strongly associated with presence and severity of knee pain, structural deterioration, disease progression with an increased risk of total knee arthroplasty. OA-related BMLs may regress or resolve within 30 months which could be associated with long lasting disability. It has been reported that BMLs persist in the majority of knee OA patients. Different treatment strategies have been proposed including rest and protected weight-bearing, bisphosphonates, subchondroplasty and intraosseous orthobiologic injection. However, conservative treatment response takes a long time and other interventions may be considered invasive procedures that show varying results with several side effects. Focused extracorporeal shockwave therapy (f-ESWT) has been established as a safe non-invasive treatment with positive results in different bone disorders that share the same pathological features of BMLs. This is an exploratory, randomized-controlled, pilot study to determine the efficacy and safety of f-ESWT compared to the standard-of-care (analgesics and protected weight bearing) for the treatment of BMLs in patients with knee OA. Thirty subjects with knee OA who have history of knee pain at rest and during walking with the confirmed diagnosis of subchondral BML(s) on magnetic resonance imaging (MRI) despite at least 4 weeks of conservative treatment will be enrolled into this study. Subjects will receive a total of 4 sessions (at high energy level) over 4 consecutive weeks. Participants will be evaluated for adverse events and changes in pain intensity and knee function, using an 11-point numerical rating scale (NRS; 0-10, with anchors "no pain" and "pain as bad as you can imagine") and; the Knee injury and Osteoarthritis Outcome Score, respectively. Subjects will be assessed with these outcome measures at baseline, 1 month, 2 months, 3 months, and 6 months after the treatment. MRI of the involved knee will be perf
Conditions Studied
Interventions
- DEVICE Focused extracorporeal shockwave therapy
Study Locations (2)
New Jersey
- New Jersey Regenerative Institute — Cedar Knolls
- Nathan Hogaboom — West Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-10-13 |
| Est. Completion | 2026-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05596591
The ClinicalTrials.gov registry entry for NCT05596591 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kessler Foundation, which has 363 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Knee Osteoarthritis appearing as the primary indexed condition, and to 1 intervention — of which Focused extracorporeal shockwave therapy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05596591 reports 2 study locations spanning 1 distinct geographic area — top geographies include New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05596591 about?
NCT05596591 is a clinical study titled "Focused Extracorporeal Shockwave Therapy for Knee Arthritis". Subchondral bone marrow lesions (BMLs) in knee osteoarthritis (OA) are strongly associated with presence and severity of knee pain, structural deterioration, disease progression with an increased risk of total knee arthroplasty. OA-related BMLs may regress or resolve within 30 months which could be ...
What is the current status of trial NCT05596591?
This trial is currently recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2022-10-13. Estimated completion is 2026-12.
What conditions does trial NCT05596591 study?
This clinical trial studies the following conditions: Knee Osteoarthritis, Knee Pain Chronic, Bone Marrow Edema. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05596591?
The interventions under investigation include: Focused extracorporeal shockwave therapy (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05596591?
This trial is sponsored by Kessler Foundation, which has 363 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05596591 being conducted?
This trial has 2 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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