Focused Shockwave Therapy for Knee Osteoarthritis

At a Glance

Age: 30 – 80
Sex: Any
Study type: Interventional
Purpose: Treatment
Participants needed: 15 (estimated)
Sponsor: Kessler Foundation · Other

Who this trial is looking for

This trial is looking for adults with knee osteoarthritis experiencing pain. Participants will receive focused shockwave therapy after not responding to other treatments for at least 4 weeks.

Are You a Good Fit for This Trial?

You may be able to join if

I am between 30 and 80 years old.
I have been diagnosed with knee osteoarthritis.
I have been experiencing knee pain for more than 2 months.
I have a score of 2-4 on the Kellgren-Lawrence scale as diagnosed on X-ray.
I have bone marrow lesions confirmed by MRI.
My knee pain is at least a 4 out of 10 during the week before joining.
My pain is only in the area of the bone marrow lesions.
I have not responded to at least 4 weeks of conservative treatment.

You may not be able to join if

I have traumatic bone marrow lesions.
My pain is caused by something other than bone marrow lesions.
I have bone marrow lesions in both knees.
I have a systemic autoimmune disease.
I am taking glucocorticoids for another condition.
I have had prior treatments for bone marrow lesions in the last 6 months.
I have had knee surgery in the past 6 months.
I am pregnant.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

About This Trial

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 k…

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.

Trial Locations

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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 …

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.

Contacts

Nathan Hogaboom, PhD

9733243584

nhogaboom@kesslerfoundation.org

CONTACT

Shalaka Paranjpe, MS

9733246643

sparanjpe@kesslerfoundation.org

CONTACT

Focused Shockwave Therapy for Knee Osteoarthritis

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