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Shockwaves could ease stubborn knee pain without surgery

NCT ID NCT05596591

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Recruiting now This study
This trial is taking on new participants right now.
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Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if focused shockwave therapy can safely reduce knee pain and improve function in people with osteoarthritis who have bone marrow lesions. Fifteen adults with persistent knee pain will receive four weekly shockwave sessions or standard care (pain relievers and rest). Researchers will track pain, knee function, and MRI changes for six months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Males and females 30-80 years old, inclusive. 2. Kellgren-Lawrence (KL) score grade 2-4 as diagnosed on X-Ray. 3. Presence of BML(s) on MRI in a weight-bearing region of the knee (medial/lateral femoral condyle or tibial plateau). 4. Knee pain for more than 2 months. 5. 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). 6. Patient pain confined to the same compartment as the BML(s). 7. Subjects would have failed a minimum of 4 weeks of conservative treatment including rest, analgesics, limited weight-bearing with or without an assistive device. Exclusion Criteria: 1. Traumatic BMLs. 2. Primary cause of patient pain and loss of function is due to pathology other than BML(s), according to patient history and clinical evaluation. 3. Presence of bilateral BML(s). 4. Systemic autoimmune diseases, such as systemic lupus erythematosus and rheumatoid arthritis. 5. Participants receiving glucocorticoids due to any other underlying disease. 6. Prior treatment for BMLs including: 1. Subchondroplasty in the involved knee. 2. 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 fraction. 7. Prior use of bisphosphonates, except according to the washout schedule: 1. 2 years (if use \> 48 weeks). 2. 1 year (if used \> 8 weeks but \< 48 weeks) 3. 6 months (if used \> 2 weeks but \< 8 weeks) 4. 2 months (if used \< 2 weeks) 5. Any intravenous bisphosphonate within the prior 2 years. 8. Intra-articular steroid injection in the prior 3 months. 9. Previous knee surgery in the past 6 months. 10. Tumors 11. Infection or fracture on ipsilateral lower limb. 12. Pregnancy. 13. Contraindications to f-ESWT, such as severe coagulopathy, malignant tumor in the treatment area. 14. Contraindications to MRI scanning including: * 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, cochlear implants, cerebral aneurysm clip, and deep brain stimulator. * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Nathan Hogaboom

    RECRUITING

    West Orange, New Jersey, 07052, United States

  • New Jersey Regenerative Institute

    RECRUITING

    Cedar Knolls, New Jersey, 07927, United States

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