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RECRUITING
NCT07887893
NA

Extracorporeal Shock Wave Therapy in the Treatment of Periarticular Bone Marrow Edema in Patients With Knee Osteoarthritis

Sponsor: Dokuz Eylul University

View on ClinicalTrials.gov

Summary

Bone marrow edema (BME) is a radiological finding characterized by increased fluid content and structural changes within the bone marrow. It most commonly affects weight-bearing joints such as the hip, knee, and ankle. Patients with BME may present with pain during activity or at rest, tenderness, swelling, joint effusion, and limitation of joint motion. Magnetic resonance imaging (MRI) is considered the gold standard for diagnosis. BME is commonly observed in patients with knee osteoarthritis (OA) and may be associated with increased pain, impaired joint function, and progression of structural joint damage. Therefore, recognition and treatment of BME may be clinically important in patients with knee OA. Treatment options for BME include conservative and surgical approaches. Standard conservative treatment generally includes activity and weight-bearing modification, analgesics and nonsteroidal anti-inflammatory drugs, and physical therapy modalities. Extracorporeal shock wave therapy (ESWT) is one of the non-invasive physical therapy options that can be added to standard conservative treatment. Surgical treatment, including core decompression, may be considered in patients who do not respond to conservative treatment. ESWT may exert beneficial effects by improving local blood flow, promoting angiogenesis, stimulating bone remodeling and regeneration, and providing analgesia. Previous studies in patients with knee-related BME have suggested that ESWT may reduce pain, improve functional outcomes, and decrease BME findings on MRI. Kang et al. reported more rapid improvements in pain, functional outcomes, and the MRI-detected area of BME within three months with ESWT compared with alendronate therapy. Sansone et al. found that ESWT resulted in greater reductions in pain and BME area, together with clinically meaningful improvement at three months, compared with conservative treatment consisting of unloading and analgesics. In a prospective randomized controlled trial, Gao et al. further showed that ESWT provided more favorable six-month outcomes in terms of pain, functional scores, and MRI-assessed BME area than intravenous prostacyclin combined with oral bisphosphonate therapy. Collectively, these findings suggest that ESWT may provide sustained clinical and radiological benefits in patients with knee BME. This study aims to investigate the effects of adding ESWT to standard conservative treatment in patients with knee osteoarthritis accompanied by bone marrow edema. Patients receiving active ESWT will be compared with those receiving sham ESWT in terms of pain, functional outcomes, patient satisfaction, and changes in bone marrow edema volume on MRI.

Official title: Effectiveness of Extracorporeal Shock Wave Therapy on Periarticular Bone Marrow Edema in Patients With Knee Osteoarthritis: A Randomized Double-Blind Sham-Controlled Trial

Key Details

Gender

All

Age Range

40 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-03-26

Completion Date

2026-12-01

Last Updated

2026-10-22

Healthy Volunteers

Yes

Interventions

DEVICE

Radial Extracorporeal Shock Wave Therapy

Radial extracorporeal shock wave therapy (ESWT) will be administered once weekly for 5 consecutive weeks using a BTL-6000 SWT TOPLINE shock wave therapy device. Each session will consist of 2,000 shock waves delivered at a frequency of 6-8 hertz (Hz) and a pressure of 1.8-2.5 bar. The ESWT probe will be placed directly on the skin over the predetermined bone marrow edema (BME) area identified by magnetic resonance imaging (MRI).

DEVICE

Sham Radial Extracorporeal Shock Wave Therapy

Sham radial extracorporeal shock wave therapy (ESWT) will be administered once weekly for 5 consecutive weeks using the same BTL-6000 SWT TOPLINE device. The device will be operated at a low setting to reproduce the characteristic treatment sound without delivering therapeutically effective shock waves. The ESWT probe will be held close to the skin over the predetermined bone marrow edema (BME) area identified by magnetic resonance imaging (MRI), without direct contact. Simultaneously, an inactive ultrasound probe similar in size to the ESWT probe will be placed directly on the skin over the treatment area to reproduce the physical sensation of active treatment.

Locations (1)

Dokuz Eylul University

Izmir, Balcova, Turkey (Türkiye)