What side effects are associated with this type of intervention?

Focused Extracorporeal Shockwave Therapy (f-ESWT) is generally considered safe with minimal side effects, which may include transient pain, redness, or swelling at the treatment site. Other common treatments for Bone Marrow Edema, such as bisphosphonates, can cause gastrointestinal issues, musculoskeletal pain, and, rarely, osteonecrosis of the jaw. Subchondroplasty and intraosseous orthobiologic injections are more invasive and can lead to complications such as infection, bleeding, and post-procedural pain. Rest and protected weight-bearing are conservative approaches with no significant side effects but may result in prolonged recovery time.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Bone Marrow Edema (BME) that directly match the mechanism of action of Focused Extracorporeal Shockwave Therapy (f-ESWT). However, treatments that aim to improve blood flow and stimulate cellular repair, such as bisphosphonates and other conservative management strategies, are commonly used. These treatments focus on reducing pain and inflammation associated with BME. f-ESWT is being studied as a non-invasive alternative that may offer benefits in terms of pain relief and functional improvement by enhancing blood flow and promoting tissue repair.

What other types of research exist?

Promising novel alternatives to f-ESWT for Bone Marrow Edema patients include: 1) Bisphosphonates, which help in bone remodeling and reducing bone pain. 2) Subchondroplasty, a minimally invasive procedure that injects bone substitute material to support healing. 3) Intraosseous orthobiologic injections, which involve injecting biologic agents to promote bone healing. These alternatives have shown varying degrees of success in treating bone-related conditions and may be considered based on individual patient needs and responses.

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Other

Shockwave Therapy for Chronic Knee Pain

N/A

Recruiting

Research Sponsored by Kessler Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a non-invasive treatment using sound waves to help people with knee arthritis who have not improved with standard treatments. The goal is to see if this new method can reduce pain and improve knee function better than current care options. Wearable long-duration low-intensity ultrasound is an emerging non-invasive and non-narcotic therapy for the daily treatment of musculoskeletal pain.

Who is the study for?

This trial is for men and women aged 30-80 with knee pain from osteoarthritis, confirmed by MRI to have bone marrow lesions. They should have tried conservative treatments like rest and analgesics for at least 4 weeks without success. People with severe coagulopathy, tumors in the treatment area, recent knee surgery or injections, metal implants incompatible with MRI, pregnancy, or autoimmune diseases cannot participate.

What is being tested?

The study tests focused extracorporeal shockwave therapy (f-ESWT) against standard care (analgesics and non-weight bearing) for treating bone marrow lesions in knee osteoarthritis. Thirty participants will be randomly assigned to receive either f-ESWT over four sessions or standard care. Pain intensity and knee function will be measured over six months using scales and MRIs.

What are the potential side effects?

Potential side effects of f-ESWT may include temporary pain at the treatment site, swelling, bruising, numbness or tingling. Standard care side effects depend on the specific analgesics used but could include gastrointestinal issues or increased risk of bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)

Change in bone marrow lesion area

Change in knee pain numerical rating scale scores

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Participants will receive four sessions over four consecutive weeks (one per week) of focused extracorporeal shockwave therapy.

Group II: ControlActive Control1 Intervention

Participants will receive the conventional treatment for bone marrow lesions, which includes avoidance of weight bearing and anti-inflammatory medications.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Bone Marrow Edema (BME) include rest and protected weight-bearing, bisphosphonates, subchondroplasty, intraosseous orthobiologic injections, and Focused Extracorporeal Shockwave Therapy (f-ESWT). Rest and protected weight-bearing help reduce mechanical stress on the affected area, allowing natural healing processes to occur. Bisphosphonates work by inhibiting bone resorption, which can help stabilize the bone structure. Subchondroplasty involves injecting a bone substitute material to support the subchondral bone, while intraosseous orthobiologic injections aim to promote healing through the introduction of biologic agents. f-ESWT, specifically, stimulates cellular repair processes and improves blood flow, which can accelerate healing and reduce pain. These treatments are crucial for BME patients as they address both the symptoms and underlying causes, potentially preventing further structural deterioration and improving overall joint function.