Pilot Study of Focused Extracorporeal Shockwave Therapy for Treating Bone Marrow Lesions in Knee Osteoarthritis

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 mJmm. 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.

Focused Extracorporeal Shockwave Therapy for Knee Arthritis