Clinical trial for Bone Marrow Edema
Official title Focused Extracorporeal Shockwave Therapy for Knee Arthritis
ClinicalTrials.gov ID: NCT05596591
What this study is testing
- What it's testing
- The study compares shockwave therapy to usual care (pain medicine and limited weight‑bearing) to see if it reduces pain and improves knee function and to check safety.
- Who it's for
- Adults with knee osteoarthritis who still have knee pain after at least 4 weeks of rest and pain medicine and who have bone marrow lesions seen on an MRI.
- What's involved
- Participants receive four high‑energy shockwave sessions over four weeks, then have pain and function tests and MRIs at several follow‑up visits.
- Time commitment
- The study lasts about six months, with visits at baseline, 1, 2, 3, and 6 months after treatment for assessments and MRIs.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 80
You may be able to join if
- Males and females 30-80 years old, inclusive.
- Kellgren-Lawrence (KL) score grade 2-4 as diagnosed on X-Ray.
- Presence of BML(s) on MRI in a weight-bearing region of the knee (medial/lateral femoral condyle or tibial plateau).
- Knee pain for more than 2 months.
- Knee pain intensity during the week leading up to the screening visit is at least 4 out of 10 on an 11-point numerical rating scale (NRS; 0, no pain
You likely can't join if
- Traumatic BMLs.
- Primary cause of patient pain and loss of function is due to pathology other than BML(s), according to patient history and clinical evaluation.
- Presence of bilateral BML(s).
- Systemic autoimmune diseases, such as systemic lupus erythematosus and rheumatoid arthritis.
- Participants receiving glucocorticoids due to any other underlying disease.
- Subchondroplasty in the involved knee.
See the full eligibility criteria
- Males and females 30-80 years old, inclusive.
- Kellgren-Lawrence (KL) score grade 2-4 as diagnosed on X-Ray.
- Presence of BML(s) on MRI in a weight-bearing region of the knee (medial/lateral femoral condyle or tibial plateau).
- Knee pain for more than 2 months.
- Knee pain intensity during the week leading up to the screening visit is at least 4 out of 10 on an 11-point numerical rating scale (NRS; 0, no pain; 10, maximum pain imaginable).
- Patient pain confined to the same compartment as the BML(s).
- people would have failed a minimum of 4 weeks of conservative treatment including rest, analgesics, limited weight-bearing with or without an assistive device.
- Traumatic BMLs.
- Primary cause of patient pain and loss of function is due to pathology other than BML(s), according to patient history and clinical evaluation.
- Presence of bilateral BML(s).
- Systemic autoimmune diseases, such as systemic lupus erythematosus and rheumatoid arthritis.
- Participants receiving glucocorticoids due to any other underlying disease.
- Subchondroplasty in the involved knee.
- Intraosseous and/or intra-articular injection of orthobiologics in the past 6 months, such as platelet rich plasma (PRP), bone marrow aspirate concentrates, micro-fragmented adipose tissue (MFAT) or stromal vascular...
- 2 years (if use \> 48 weeks).
- 1 year (if used \> 8 weeks but \< 48 weeks)
- 6 months (if used \> 2 weeks but \< 8 weeks)
- 2 months (if used \< 2 weeks)
- Any intravenous bisphosphonate within the prior 2 years.
- Intra-articular steroid injection in the prior 3 months.
- Previous knee surgery in the past 6 months.
- Tumors
- Infection or fracture on ipsilateral lower limb.
- Pregnancy.
- Contraindications to f-ESWT, such as severe coagulopathy, malignant tumor in the treatment area.
- Presence of metal implants such as implanted pacemaker, metal sutures, metallic protheses (including metal pins and rods, heart valves), presence of shrapnel or iron filings in the eye, magnetic dental implants...
- Claustrophobia.
- The patient has been informed by his/her doctor that it is medically unsafe to receive regular MRI as part of his/her medical care.
The study team makes the final eligibility decision.
Where it is enrolling
- Cedar Knolls, New Jersey, United States
- West Orange, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Cedar Knolls, New Jersey, United States; West Orange, New Jersey, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.