NCT05596591 Focused Extracorporeal Shockwave Therapy for Knee Arthritis
| NCT ID | NCT05596591 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kessler Foundation |
| Condition | Bone Marrow Edema |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2022-10-13 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2022-10-13 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 performed prior to treatment (baseline) and 3 months and 6 months after treatment.
Eligibility Criteria
Inclusion Criteria: 1. Males and females 30-80 years old, inclusive. 2. Kellgren-Lawrence (KL) score grade 2-4 as diagnosed on X-Ray. 3. Presence of BML(s) on MRI in a weight-bearing region of the knee (medial/lateral femoral condyle or tibial plateau). 4. Knee pain for more than 2 months. 5. Knee pain intensity during the week leading up to the screening visit is at least 4 out of 10 on an 11-point numerical rating scale (NRS; 0, no pain; 10, maximum pain imaginable). 6. Patient pain confined to the same compartment as the BML(s). 7. Subjects would have failed a minimum of 4 weeks of conservative treatment including rest, analgesics, limited weight-bearing with or without an assistive device. Exclusion Criteria: 1. Traumatic BMLs. 2. Primary cause of patient pain and loss of function is due to pathology other than BML(s), according to patient history and clinical evaluation. 3. Presence of bilateral BML(s). 4. Systemic autoimmune diseases, such as systemic lupus erythematosus and rheumatoid arthritis. 5. Participants receiving glucocorticoids due to any other underlying disease. 6. Prior treatment for BMLs including: 1. Subchondroplasty in the involved knee. 2. Intraosseous and/or intra-articular injection of orthobiologics in the past 6 months, such as platelet rich plasma (PRP), bone marrow aspirate concentrates, micro-fragmented adipose tissue (MFAT) or stromal vascular fraction. 7. Prior use of bisphosphonates, except according to the washout schedule: 1. 2 years (if use \> 48 weeks). 2. 1 year (if used \> 8 weeks but \< 48 weeks) 3. 6 months (if used \> 2 weeks but \< 8 weeks) 4. 2 months (if used \< 2 weeks) 5. Any intravenous bisphosphonate within the prior 2 years. 8. Intra-articular steroid injection in the prior 3 months. 9. Previous knee surgery in the past 6 months. 10. Tumors 11. Infection or fracture on ipsilateral lower limb. 12. Pregnancy. 13. Contraindications to f-ESWT, such as severe coagulopathy, malignant tumor in the treatment area. 14. Contraindications to MRI scanning including: * Presence of metal implants such as implanted pacemaker, metal sutures, metallic protheses (including metal pins and rods, heart valves), presence of shrapnel or iron filings in the eye, magnetic dental implants, cochlear implants, cerebral aneurysm clip, and deep brain stimulator. * Claustrophobia. * The patient has been informed by his/her doctor that it is medically unsafe to receive regular MRI as part of his/her medical care.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05596591 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 80 Years, studying Bone Marrow Edema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05596591 currently recruiting?
Yes, NCT05596591 is actively recruiting participants. Contact the research team at nhogaboom@kesslerfoundation.org for enrollment information.
Where is the NCT05596591 trial being conducted?
This trial is being conducted at Cedar Knolls, United States, West Orange, United States.
Who is sponsoring the NCT05596591 clinical trial?
NCT05596591 is sponsored by Kessler Foundation. The trial plans to enroll 15 participants.