Taking people in United StatesNo phase

Shockwave therapy for bone marrow lesions in knee osteoarthritis

Tests shockwave therapy for painful knee osteoarthritis with bone marrow lesions.

Key facts

Who runs it: Kessler Foundation
Where: Cedar Knolls and West Orange, United StatesSee the 2 sites
Trial code: NCT05596591
Registry title: Focused Extracorporeal Shockwave Therapy for Knee Arthritis
Status: Recruiting
People taking part: 15 people, planned
Started: 13 Oct 2022
Expected to end: Dec 2027
Type of study: Interventional
Treatments tested: Focused extracorporeal shockwave therapy
Record updated: 27 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with knee osteoarthritis and bone marrow lesions seen on MRI. They must still have knee pain after at least 4 weeks of conservative treatment.

Age: 30 to 80 years
Sex: Men and women
Disease stage: Knee osteoarthritis with Kellgren-Lawrence grade 2-4 on X-ray. Bone marrow lesions in a weight-bearing part of the knee. Knee pain for more than 2 months, at least 4 out of 10 in the week before screening. The pain must be in the same part of the knee as the lesions.
Earlier treatment: Must have had at least 4 weeks of conservative treatment without enough help, such as rest, pain medicine and limited weight-bearing. Cannot join after subchondroplasty in that knee. Cannot join after orthobiologic injections (such as PRP) in the past 6 months, a steroid injection in the knee in the past 3 months, or knee surgery in the past 6 months. Bisphosphonates must have been stopped for a set time, and no intravenous bisphosphonate in the past 2 years.
Biomarker or test result: Bone marrow lesion(s) seen on MRI.

Main reasons for not taking part

Bone marrow lesions caused by injury, or lesions in both knees
Autoimmune diseases such as lupus or rheumatoid arthritis, or taking glucocorticoids
Tumors, or infection or fracture in the same leg
Pregnancy
Cannot have MRI, for example metal implants, pacemaker or fear of closed spaces

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

Males and females 30-80 years old, inclusive
Kellgren-Lawrence (KL) score grade 2-4 as diagnosed on X-Ray
Presence of BML(s) on MRI in a weight-bearing region of the knee (medial/lateral femoral condyle or tibial plateau)
Knee pain for more than 2 months
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)
Patient pain confined to the same compartment as the BML(s)
Subjects would have failed a minimum of 4 weeks of conservative treatment including rest, analgesics, limited weight-bearing with or without an assistive device

Who cannot take part

Participants receiving glucocorticoids due to any other underlying disease
Prior use of bisphosphonates, except according to the washout schedule:; 2 years (if use > 48 weeks); 1 year (if used > 8 weeks but < 48 weeks); 6 months (if used > 2 weeks but < 8 weeks); 2 months (if used < 2 weeks); Any intravenous bisphosphonate within the prior 2 years
Intra-articular steroid injection in the prior 3 months
Previous knee surgery in the past 6 months
Systemic autoimmune diseases, such as systemic lupus erythematosus and rheumatoid arthritis
Infection or fracture on ipsilateral lower limb
Contraindications to f-ESWT, such as severe coagulopathy, malignant tumor in the treatment area
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
Prior treatment for BMLs including:; Subchondroplasty in the involved knee; 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
Traumatic BMLs
Primary cause of patient pain and loss of function is due to pathology other than BML(s), according to patient history and clinical evaluation
Presence of bilateral BML(s)
Tumors
Pregnancy

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 30 and 80 years old?

Where in United States

New Jersey Regenerative InstituteCedar Knolls, United StatesContact: Jay Bowen, DOTaking people
Nathan HogaboomWest Orange, United StatesContact: Nathan Hogaboom, PhDTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

InterventionTreatment being tested
Participants will receive four sessions over four consecutive weeks (one per week) of focused extracorporeal shockwave therapy.
Treatment: Focused extracorporeal shockwave therapy