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

Key facts

Who runs it
Dokuz Eylul University
Where
Türkiye1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
24 people, planned
Started
26 Mar 2026
Expected to end
1 Dec 2026
Type of study
Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
Treatments tested
  • Radial Extracorporeal Shock Wave Therapy
  • Sham Radial Extracorporeal Shock Wave Therapy
Record updated
22 October 2026

Who can take part

Age
40 years to 70 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

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Who can take part

  • Aged 40-70 years
  • Radiographic evidence of knee osteoarthritis classified as Kellgren-Lawrence grade 2 or 3
  • Unilateral BME in the bones around the knee, limited to either the medial or lateral compartment of the knee joint, as confirmed by MRI. The affected sites may include the medial femoral condyle, medial tibial plateau, or both; or the lateral femoral condyle, lateral tibial plateau, or both
  • Willingness to participate in the study
  • Provision of written informed consent

Who cannot take part

  • Physical therapy, corticosteroid injection, or surgery involving the affected area within the previous 6 months
  • Previous ESWT treatment
  • Open wounds, infection, bleeding, skin lesions, or metal implants around the knee
  • Presence of a cardiac pacemaker
  • Peripheral arterial occlusive disease
  • Polyneuropathy or sensory impairment
  • Inflammatory rheumatic disease
  • Severe cardiovascular disease
  • History of epilepsy
  • History of malignancy
  • Bleeding disorders
  • Insufficient cognitive ability to complete the questionnaires
  • 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 40 and 70 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

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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.

The 2 groups in the trial

  • Radial extracorporeal shock wave therapyTreatment being tested

    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 treatment 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. Treatment will be applied directly to the skin over the predetermined bone marrow edema (BME) area identified by magnetic resonance imaging (MRI). Participants will also receive standard conservative treatment throughout the study period (13 weeks).

  • Sham radial extracorporeal shock wave therapySham treatment, for comparison

    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 sufficient to reproduce the characteristic treatment sound without delivering therapeutically effective shock waves. The ESWT probe will be held close to, but without direct contact with, the skin over the predetermined bone marrow edema (BME) area identified by magnetic resonance imaging (MRI). At the same time, an inactive ultrasound probe similar in size to the ESWT probe will be applied directly to the skin over the treatment area to reproduce the physical sensation of active treatment. During each session, participants will wear an eye mask, and both researchers will be present in the treatment room to maintain standardized treatment conditions and participant blinding. All participants will receive the same standard conservative treatment as the active ESWT group.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Fit questions
Built from NCT07887893, who can take part
Record updated
22 October 2026