An interventional study of Radial Extracorporeal Shock Wave Therapy and Sham Radial Extracorporeal Shock Wave Therapy in Knee Arthritis, Osteoarthritis, Bone Marrow Edema of the Knee and Bone Marrow Edema, sponsored by Dokuz Eylul University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Dokuz Eylul University · Not applicable, Interventional, and Treatment
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.
Bone marrow edema (BME) is a common magnetic resonance imaging (MRI) finding in patients with knee osteoarthritis (OA) and is associated with pain, functional impairment, and structural progression of the disease. MRI is considered the gold standard imaging method for the diagnosis of BME. In the early stages, BME typically appears as an area of low signal intensity on T1-weighted images and high signal intensity on fluid-sensitive sequences, particularly T2-weighted, fat-suppressed, and short tau inversion recovery (STIR) images. These findings reflect increased water content and inflammatory changes within the bone marrow. As the lesion progresses, a subchondral pattern with low signal intensity on both T1- and T2-weighted images may develop, reflecting more advanced structural changes in the subchondral bone. BME is thought to represent an active pathological process involving subchondral bone damage, bone remodeling, inflammation, vascular changes, and altered mechanical loading.
Conservative treatment is generally considered the first-line treatment for BME and includes reducing weight-bearing on the affected limb, activity modification, pain control, and physical therapy modalities. Extracorporeal shock wave therapy (ESWT) is a noninvasive treatment modality used in various musculoskeletal disorders. Its proposed effects include improving local blood flow, promoting angiogenesis and bone remodeling, stimulating osteogenic activity, and reducing pain. Previous studies have suggested that ESWT may reduce pain, improve functional outcomes, and improve MRI findings in patients with BME. However, evidence regarding the effectiveness of ESWT specifically in patients with periarticular BME associated with knee OA remains limited. Further investigation is needed to determine its effects on clinical outcomes and quantitative volumetric changes in BME.
This study is a prospective, randomized, double-blind, sham-controlled clinical trial designed to investigate the effects of radial ESWT in patients with knee OA accompanied by periarticular BME. A total of 24 patients aged 40-70 years who present to the Department of Physical Medicine and Rehabilitation at Dokuz Eylül University Faculty of Medicine with knee pain and meet the eligibility criteria will be included. Eligible patients will have knee OA based on clinical findings, Kellgren-Lawrence grade 2 or 3 disease on radiographs, and unilateral BME involving the bones around the knee joint on MRI. The BME lesion must be limited to one compartment of the knee, either the medial or lateral compartment. In the medial compartment, the lesion may involve the medial femoral condyle, medial tibial plateau, or both. In the lateral compartment, it may involve the lateral femoral condyle, lateral tibial plateau, or both. Patients who meet the eligibility criteria and provide written informed consent will be randomly assigned to either the active ESWT group or the sham ESWT group, with 12 patients in each group. Randomization will be performed using a sealed-envelope method. Group allocation will be concealed using sequentially numbered, opaque, sealed envelopes, which will be opened only after participant enrollment.
Both groups will receive the same standard conservative treatment for BME throughout the study. Patients will be instructed to reduce weight-bearing on the affected limb for five weeks and to use a cane or crutches to avoid full weight-bearing. They will be allowed to continue their usual daily and work-related activities while avoiding movements that aggravate their symptoms or place excessive stress on the affected knee. Paracetamol will be permitted as rescue medication when needed, while other analgesic medications will not be allowed. The total number of 500 mg paracetamol tablets consumed will be recorded during the study period. No additional physical therapy modalities, intra-articular injections, or surgical procedures will be permitted during the study period. Thus, ESWT will be evaluated as an additional treatment to standard conservative management rather than as a stand-alone treatment.
In the active ESWT group, radial shock wave therapy will be applied to the predetermined BME area identified on MRI. The ESWT probe will be placed directly on the skin over the treatment area. 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 administered once weekly for five consecutive weeks, for a total of five ESWT sessions. During each treatment session, both researchers will be present in the treatment room. The first researcher will administer ESWT, while the second researcher will remain in the room without performing any additional intervention.
In the sham ESWT group, treatment will be administered according to the same schedule. The ESWT 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 treatment area without direct contact with the skin. At the same time, the second researcher will place the inactive probe of a switched-off ultrasound device, similar in size to the ESWT probe, directly on the skin over the BME area to reproduce the physical sensation of treatment.
To maintain participant blinding, patients in both groups will wear an eye mask throughout each treatment session and will not be able to observe the devices or procedures being performed. Both researchers will be present in the treatment room during all active and sham treatment sessions. The duration of the sessions, patient positioning, device sounds, and overall treatment environment will be kept as similar as possible between the two groups. These standardized procedures will be used to minimize differences between active and sham treatment sessions and to prevent participants from determining their treatment allocation.
Before treatment, demographic and clinical characteristics of the participants will be recorded. Pain intensity will be evaluated using the visual analog scale (VAS), and symptoms and functional status related to knee OA will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Both assessments will be performed at baseline, immediately after completion of the five-week treatment period (week 5), four weeks after treatment completion (week 9), and eight weeks after treatment completion (week 13).
BME volume will be evaluated using MRI at baseline and week 13. Volumetric changes in BME lesions will be measured to assess the radiological response to treatment. All MRI examinations will be evaluated by a single experienced radiologist who will be blinded to treatment allocation. Patient satisfaction will be assessed at weeks 5, 9, and 13. Paracetamol consumption will be documented as the number of 500 mg tablets used during three intervals: baseline to week 5, week 5 to week 9, and week 9 to week 13.
The primary outcomes of the study will be changes in pain intensity assessed by the VAS and changes in BME volume assessed by MRI. Secondary outcomes will include changes in WOMAC total scores and patient satisfaction. Paracetamol consumption will be recorded as an additional outcome measure. The study aims to determine whether adding radial ESWT to standard conservative treatment provides additional clinical and radiological benefits in patients with knee OA-associated periarticular BME.
4,445 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 24 is below the median of 70 across 3,474 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Dokuz Eylul University is the lead sponsor of 257 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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).
Device: 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 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.
Device: Sham 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).
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.
Magnetic Resonance Imaging (MRI) Findings: Volumetric Assessment of Bone Marrow Edema
The volume of the bone marrow edema (BME) lesion will be assessed using magnetic resonance imaging (MRI). MRI examinations will be performed using the same 1.5-tesla MRI scanner for all participants. Imaging parameters will be standardized, including a slice thickness of 3 mm and a coronal spectral attenuated inversion recovery (SPAIR) sequence with a matrix size of 432 × 432. The symptomatic knee will be evaluated, and the BME lesion will be localized to either the medial or lateral compartment of the knee. The medial compartment will include the medial femoral condyle, medial tibial plateau, or both, while the lateral compartment will include the lateral femoral condyle, lateral tibial plateau, or both. The BME lesion will be manually delineated on consecutive MRI slices using image analysis software. Lesion volume will be calculated by summing the volumes of the segmented voxels and expressed in cubic millimeters (mm³). MRI examinations will be performed at baseline and week 13.
Time frame: Baseline (before treatment initiation) and week 13 (8 weeks after completion of the 5-week treatment period).
Visual Analog Scale (VAS)
Pain intensity will be assessed using the visual analog scale (VAS), which consists of a 10-cm horizontal line, with 0 indicating "no pain" and 10 indicating "the worst pain imaginable." Participants will mark the point on the scale that best represents their current pain intensity. The distance from the zero point to the participant's mark will be measured in centimeters, resulting in a score ranging from 0 to 10. Higher scores indicate greater pain intensity.
Time frame: Baseline (before treatment initiation),week 5 (immediately after completion of treatment), week 9 (4 weeks after treatment completion), and week 13 (8 weeks after treatment completion).
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a validated self-administered questionnaire designed to assess symptoms and functional status in patients with knee and hip osteoarthritis. The WOMAC consists of 24 items divided into three subscales: pain (5 items), stiffness (2 items), and physical function (17 items). Each item is scored on a 5-point Likert scale ranging from 0 ("none") to 4 ("extreme"). The scores of all 24 items will be summed to calculate a total WOMAC score ranging from 0 to 96. Higher total scores indicate greater symptom severity and functional impairment.
Time frame: Baseline (before treatment initiation),week 5 (immediately after completion of treatment), week 9 (4 weeks after treatment completion), and week 13 (8 weeks after treatment completion).
Patient Satisfaction
Patient satisfaction with treatment will be assessed using a 5-point scale with the following response options: completely satisfied (5 points), almost satisfied (4 points), moderately satisfied (3 points), somewhat satisfied (2 points), and dissatisfied (1 point). The total score ranges from 1 to 5, with higher scores indicating greater patient satisfaction.
Time frame: Baseline (before treatment initiation),week 5 (immediately after completion of treatment), week 9 (4 weeks after treatment completion), and week 13 (8 weeks after treatment completion).
Paracetamol Use
The total number of 500 mg paracetamol tablets used as rescue medication for pain relief will be recorded for each participant throughout the 13-week study period. Paracetamol consumption will be assessed separately during three intervals: baseline to Week 5, Week 5 to Week 9, and Week 9 to Week 13. Participants who do not use paracetamol will be assigned a value of zero.
Time frame: Baseline (before treatment initiation),week 5 (immediately after completion of treatment), week 9 (4 weeks after treatment completion), and week 13 (8 weeks after treatment completion).
Plan to share: No
Started Mar 2026 (actual). Primary completion is estimated for Nov 2026, 7 months after the start.
Of 1,126 non-industry interventional studies with no phase under Osteoarthritis, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's planned 7 months is below that.
Counting every sponsor, half of 1,315 studies reached it within 19 months; a quarter within 8 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.