Focused Extracorporeal Shockwave Therapy for Knee Arthritis

Launched by KESSLER FOUNDATION · Oct 24, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called focused extracorporeal shockwave therapy (f-ESWT) for patients with knee osteoarthritis (OA) who also have subchondral bone marrow lesions (BMLs), which can cause significant pain and limit movement. The goal is to see if f-ESWT is more effective and safer than the standard treatment, which typically involves pain medications and limiting activity. The study will include 30 participants aged 30 to 80 who have experienced knee pain for at least two months and have not found relief from other treatments for at least four weeks.

Participants in the trial will be randomly assigned to either receive f-ESWT, which involves four sessions over four weeks, or to continue with standard care. Throughout the study, participants will be asked about their pain levels and knee function at different times, and they will also undergo MRI scans to monitor changes in their condition. This trial is currently recruiting participants, and it’s important to note that certain health conditions or prior treatments may disqualify some individuals from participating. If you or someone you know is interested, it might be a good idea to talk to a healthcare provider to see if they qualify.

Gender

ALL

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.