Focused shockwave therapy for knee arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This exploratory pilot study aims to evaluate the efficacy and safety of focused extracorporeal shockwave therapy (f-ESWT) for treating subchondral bone marrow lesions (BMLs) in individuals with knee osteoarthritis (OA). The study will enroll 15 participants aged 30-80 who have experienced knee pain for over two months and have not responded to at least four weeks of conservative treatment. Participants will receive four sessions of high-energy f-ESWT targeting the affected areas of the knee. The goal is to determine whether this non-invasive treatment can alleviate pain and improve function in patients with BMLs associated with knee OA.

Why it matters

Who can join: the full rules

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.

Where it's running

• New Jersey Regenerative Institute
  Cedar Knolls, New Jersey, United States Recruiting
• Nathan Hogaboom
  West Orange, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Nathan Hogaboom, PhD
• Email: nhogaboom@kesslerfoundation.org
• Phone: 9733243584

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.