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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
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
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 moreTrial 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.
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.
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Who is running the clinical trial?
New Jersey Regenerative Institute, LLCIndustry Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
Kessler FoundationLead Sponsor
178 Previous Clinical Trials
10,958 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I've tried basic treatments like rest and pain relief for over 4 weeks without improvement.I haven't had treatments like PRP or bone marrow injections in my knee in the last 6 months.I have a systemic autoimmune disease like lupus or rheumatoid arthritis.I've had injections like PRP or stem cells in my bones or joints in the last 6 months.I am between 30 and 80 years old.My MRI shows bone marrow lesions in the knee's weight-bearing areas.My X-ray shows moderate to severe arthritis.I have had knee pain for over 2 months.My knee pain has been at least a 4 out of 10 in the past week.My pain is located in the same area as my bone marrow lesions.My pain and loss of function are not mainly due to bone marrow lesions.I am taking steroids for a condition other than cancer.I have not taken any IV bisphosphonate drugs in the last 2 years.I have had a steroid injection into a joint in the last 3 months.My pain is located in the same area as my bone marrow lesions.My X-Ray shows moderate to severe arthritis.My MRI shows bone marrow lesions in the knee's weight-bearing areas.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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