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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
Study Summary
This trial studies how shockwave therapy can reduce knee pain and improve knee function in those with knee osteoarthritis who have subchondral bone marrow lesions.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
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.
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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
174 Previous Clinical Trials
10,708 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants still being accepted for this medical experiment?
"Clinicaltrials.gov has confirmed that this research is actively recruiting participants, since it was initially posted on October 13th 2022 and revised on the 24th of the same month."
Answered by AI
Is geriatric recruitment being sought for this research endeavor?
"This clinical trial is seeking participants that are between the ages of 30 and 80. There are 39 studies for minors and 667 studies available to individuals over 65 years old."
Answered by AI
May I partake in the experiment?
"This clinical trial seeks 30 individuals, aged between thirty and eighty years old, who currently experience knee pain. The prospective participants must be of both genders, possess a Kellgren-Lawrence (KL) score grade ranging from 2 to 4 that is detectable on X-Ray imaging technology, have a bone marrow lesion (BML) in the weight bearing region of their knee as seen by MRI scans, report experiencing discomfort for more than two months already and said pain should be localized within the same compartment which hosts BML(s). Furthermore, subjects would need to demonstrate at least four weeks worth of unsuccessful attempts at managing their symptoms through"
Answered by AI
Who else is applying?
What site did they apply to?
Kessler Foundation
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Why did patients apply to this trial?
I’m hoping that this clinical trial will get relief on my knees without me having to get an operation.
PatientReceived 1 prior treatment
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