Actively Recruiting
Focused Extracorporeal Shockwave Therapy for Subchondral Bone Marrow Lesions in People With Knee Osteoarthritis: A Pilot Study
Led by Kessler Foundation · Updated on 2026-03-27
15
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
K
Kessler Foundation
Lead Sponsor
N
New Jersey Regenerative Institute, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research investigates the use of focused extracorporeal shockwave therapy (f-ESWT) as a treatment for subchondral bone marrow lesions (BMLs) in people with knee osteoarthritis (OA). BMLs are closely linked to knee pain, structural damage, and disease progression in knee OA, often leading to long-term disability and increased risk of knee replacement surgery. The study aims to explore the efficacy and safety of f-ESWT compared to standard care such as analgesics and protected weight bearing in patients with persistent BMLs despite conservative treatment. Participants will receive four sessions of high-energy f-ESWT over four consecutive weeks, targeting the subchondral bone area with BMLs identified by MRI. The therapy involves focused shockwaves delivered by a device at energy levels between 0.28-0.60 mJ/mm². The study will monitor changes in pain and knee function, with MRI scans performed before treatment, and at 3 and 6 months post-treatment. This pilot, randomized-controlled study includes 30 subjects who have confirmed BMLs and knee pain lasting more than 2 months. During the study, participants will be assessed at baseline, 1, 2, 3, and 6 months after treatment using an 11-point numerical rating scale for knee pain and the Knee injury and Osteoarthritis Outcome Score (KOOS) to measure knee function and quality of life. MRI imaging will evaluate the area and condition of BMLs at specified intervals. Researchers will also monitor for any adverse events throughout the trial. The total participation duration spans at least 6 months with multiple follow-up assessments to evaluate treatment outcomes and safety.
CONDITIONS
Brief Title
Focused Extracorporeal Shockwave Therapy for Knee Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 30 to 80 years old
- Kellgren-Lawrence score grade 2 to 4 on X-Ray
- Presence of bone marrow lesions on MRI in a weight-bearing region of the knee
- Knee pain lasting more than 2 months
- Knee pain intensity at least 4 out of 10 on an 11-point pain scale during the week before screening
- Pain limited to the same compartment as the bone marrow lesions
- Failure to improve after at least 4 weeks of conservative treatment including rest, analgesics, and limited weight-bearing
You will not qualify if you...
- Traumatic bone marrow lesions
- Pain or loss of function mainly caused by conditions other than bone marrow lesions
- Presence of bone marrow lesions in both knees
- Systemic autoimmune diseases such as lupus or rheumatoid arthritis
- Current use of glucocorticoids for other diseases
- Prior treatment for bone marrow lesions including subchondroplasty or orthobiologic injections within the past 6 months
- Prior use of bisphosphonates without completing required washout periods depending on duration of use
- Intra-articular steroid injection in the past 3 months
- Knee surgery within the past 6 months
- Tumors
- Infection or fracture in the same leg
- Pregnancy
- Contraindications to focused extracorporeal shockwave therapy such as severe bleeding disorders or malignant tumors in the treatment area
- Contraindications to MRI including metal implants, pacemakers, cochlear implants, aneurysm clips, shrapnel in the eye, magnetic dental implants, brain stimulators, claustrophobia, or medical advice against MRI scanning
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive four sessions of focused extracorporeal shockwave therapy over four consecutive weeks targeting the subchondral bone marrow lesions in the knee.
4 visits (once per week, in-person)
Duration - Up to 6 months after treatment
Participants are monitored for changes in knee pain, function, and bone marrow lesion status using pain scales, knee function scores, and MRI assessments.
5 visits at baseline, 1 month, 2 months, 3 months, and 6 months after treatment
Trial Site Locations
Total: 2 locations
1
New Jersey Regenerative Institute
Cedar Knolls, New Jersey, United States, 07927
Actively Recruiting
2
Nathan Hogaboom
West Orange, New Jersey, United States, 07052
Actively Recruiting
Research Team
N
Nathan Hogaboom, PhD
S
Shalaka Paranjpe, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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