Focused shockwave therapy for knee arthritis
Focused Extracorporeal Shockwave Therapy for Subchondral Bone Marrow Lesions in People With Knee Osteoarthritis: A Pilot Study
This study is testing if focused shockwave therapy can help relieve knee pain and improve movement in people with knee arthritis who haven't found relief from other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | Kessler Foundation Academic / other |
| Locations | 2 sites (Cedar Knolls, New Jersey and 1 other locations) |
| Trial ID | NCT05596591 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 30-80 with knee osteoarthritis and confirmed subchondral BMLs who have not responded to conservative treatments.
Not a fit: Patients with traumatic BMLs or those whose pain is primarily due to conditions other than BMLs may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option for patients suffering from knee pain due to osteoarthritis, potentially reducing the need for more invasive procedures.
How similar studies have performed: Previous studies have shown positive results for shockwave therapy in treating various bone disorders, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cedar Knolls, New Jersey and 1 other locations
- 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
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.