Bone Marrow EdemaNCT05596591
Focused Extracorporeal Shockwave Therapy for Knee Arthritis
A study testing Focused extracorporeal shockwave therapy in people with Bone Marrow Edema and Knee Osteoarthritis, run by Kessler Foundation at 2 sites in United States.
Trial summary
Subchondral bone marrow lesions (BMLs) in knee osteoarthritis (OA) are strongly associated with presence and severity of knee pain, structural deterioration, disease progression with an increased risk of total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Bone Marrow Edema, Knee Osteoarthritis, Knee Pain Chronic
- What is being tested?
- Focused extracorporeal shockwave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Oct 2022to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- Subjects would have failed a minimum of 4 weeks of conservative treatment including rest, analgesics, limited weight-bearing with or without an assistive device.
Who cannot join
- 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.
- Prior treatment for BMLs including:
Show all 24Show fewer
- 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 fraction.
- Prior use of bisphosphonates, except according to the washout schedule:
- 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.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
New Jersey Regenerative Institute
Cedar Knolls, New Jersey, 07927
Jay Bowen, DO, 973-998-8309
- Recruiting
Nathan Hogaboom
West Orange, New Jersey, 07052
Nathan Hogaboom, PhD, 9733243584, nhogaboom@kesslerfoundation.org
Shalaka Paranjpe, MS, 9739656643, sparanjpe@kesslerfoundation.org
About this study
Official title: Focused Extracorporeal Shockwave Therapy for Subchondral Bone Marrow Lesions in People With Knee Osteoarthritis: A Pilot Study
Subchondral bone marrow lesions (BMLs) in knee osteoarthritis (OA) are strongly associated with presence and severity of knee pain, structural deterioration, disease progression with an increased risk of total knee arthroplasty. OA-related BMLs may regress or resolve within 30 months which could be associated with long lasting disability. It has been reported that BMLs persist in the majority of knee OA patients. Different treatment strategies have been proposed including rest and protected weight-bearing, bisphosphonates, subchondroplasty and intraosseous orthobiologic injection. However, conservative treatment response takes a long time and other interventions may be considered invasive procedures that show varying results with several side effects. Focused extracorporeal shockwave therapy (f-ESWT) has been established as a safe non-invasive treatment with positive results in different bone disorders that share the same pathological features of BMLs. This is an exploratory, randomized-controlled, pilot study to determine the efficacy and safety of f-ESWT compared to the standard-of-care (analgesics and protected weight bearing) for the treatment of BMLs in patients with knee OA. Thirty subjects with knee OA who have history of knee pain at rest and during walking with the confirmed diagnosis of subchondral BML(s) on magnetic resonance imaging (MRI) despite at least 4 weeks of conservative treatment will be enrolled into this study. Subjects will receive a total of 4 sessions (at high energy level) over 4 consecutive weeks. Participants will be evaluated for adverse events and changes in pain intensity and knee function, using an 11-point numerical rating scale (NRS; 0-10, with anchors "no pain" and "pain as bad as you can imagine") and; the Knee injury and Osteoarthritis Outcome Score, respectively. Subjects will be assessed with these outcome measures at baseline, 1 month, 2 months, 3 months, and 6 months after the treatment. MRI of the involved knee will be performed prior to treatment (baseline) and 3 months and 6 months after treatment.
Read the detailed description
Background: Subchondral bone marrow lesions (BMLs) in knee osteoarthritis (OA) are strongly associated with presence and severity of knee pain, structural deterioration, disease progression with an increased risk of total knee arthroplasty. OA-related BMLs may regress or resolve within 30 months which could be associated with long lasting disability. It has been reported that BMLs persist in the majority of people with knee OA. Different treatment strategies have been proposed including rest and protected weight-bearing, bisphosphonates, subchondroplasty and intraosseous orthobiologic injection. However, conservative treatment response takes a long time and other interventions may be considered invasive procedures that show varying results with several side effects. Focused extracorporeal shockwave therapy (f-ESWT) has been established as a safe non-invasive treatment with positive results in different bone disorders that share the same pathological features of BMLs.
Objective: This is an exploratory pilot study to determine the efficacy and safety of f-ESWT for the treatment of BMLs in people with knee OA.
Participants: Fifteen subjects with knee OA who have history of knee pain at rest and during walking with the confirmed diagnosis of subchondral BML(s) on magnetic resonance imaging (MRI) despite at least 4 weeks of conservative treatment will be enrolled into this study.
Procedures: Subjects will receive a total of 4 focused ESWT sessions (at high energy level) over 4 consecutive weeks.
Outcome Measures: Participants will be evaluated for adverse events and changes in pain intensity and knee function, using an 11-point numerical rating scale (NRS; 0-10, with anchors "no pain" and "pain as bad as you can imagine") and; the Knee injury and Osteoarthritis Outcome Score (KOOS; five subscales: pain, other symptoms, function in activities of daily living, function in sports and recreation, and knee-related quality of life), respectively. Subjects will be assessed with these outcome measures at baseline, 1 month, 2 months, 3 months, and 6 months after the treatment. MRI of the involved knee will be performed prior to treatment (baseline) and 3 months and 6 months after treatment.
Anticipated Outcomes: Focused extracorporeal shockwave therapy is a safe alternative to treating BMLs and will significantly decrease knee pain intensity and improve function in people with knee OA- related BMLs.
- Conditions
- Bone Marrow Edema, Knee Osteoarthritis, Knee Pain Chronic
- Being tested
- Focused extracorporeal shockwave therapy
- Keywords
- Shockwave Therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused extracorporeal shockwave therapyDevice
High energy level shockwaves (between 0.28-0.60 mJ/mm^2) will be focused over the subchondral bone with the bone marrow lesion, previously localized on MRI.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will receive four sessions over four consecutive weeks (one per week) of focused extracorporeal shockwave therapy. Receives: Device: Focused extracorporeal shockwave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knee pain numerical rating scale scores
Twelve-week knee pain intensity will be assessed using NRS. Subjects will be asked to rate their average pain, most severe pain, and least severe pain using an 11-point scale (i.e. 0-10) anchored at the ends by "no pain" and "pain as bad as you can imagine." NRS allows comparison across clinical trials of chronic pain treatment and is recommended as a core outcome measure for chronic pain clinical trials.
Measured: 12 weeks
Secondary outcomes (9)
Change in knee pain numerical rating scale scores
Eight-week knee pain intensity will be assessed using NRS. Subjects will be asked to rate their average pain, most severe pain, and least severe pain using an 11-point scale (i.e. 0-10) anchored at the ends by "no pain" and "pain as bad as you can imagine." NRS allows comparison across clinical trials of chronic pain treatment and is recommended as a core outcome measure for chronic pain clinical trials.
Measured: 8 weeks
Change in knee pain numerical rating scale scores
Twenty-four-week knee pain intensity will be assessed using NRS. Subjects will be asked to rate their average pain, most severe pain, and least severe pain using an 11-point scale (i.e. 0-10) anchored at the ends by "no pain" and "pain as bad as you can imagine." NRS allows comparison across clinical trials of chronic pain treatment and is recommended as a core outcome measure for chronic pain clinical trials.
Measured: 24 weeks
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a comprehensive instrument widely used in research and clinical practice, including in large-scale databases and registries in the setting of knee injury and knee OA. It consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: 8 weeks
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a comprehensive instrument widely used in research and clinical practice, including in large-scale databases and registries in the setting of knee injury and knee OA. It consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: 12 weeks
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a comprehensive instrument widely used in research and clinical practice, including in large-scale databases and registries in the setting of knee injury and knee OA. It consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: 24 weeks
Change in bone marrow lesion area
Size of the BML (in mm2) will be measured by an expert musculoskeletal radiologist, who will be blinded to treatment received. The size of BMLs will be measured at baseline, 3 months, and 6 months. The maximum size of BML area will be measured manually by applying software cursors to the greatest area of the lesion at the medial tibial, medial femoral, lateral tibial, and lateral femoral sites. If more than one lesion is present at the same site, BML with the greatest area will be considered. Total bone marrow lesion size will be calculated as the sum of every lesion within each site.
Measured: 12 weeks
Change in bone marrow lesion area
Size of the BML (in mm2) will be measured by an expert musculoskeletal radiologist, who will be blinded to treatment received. The size of BMLs will be measured at baseline, 3 months, and 6 months. The maximum size of BML area will be measured manually by applying software cursors to the greatest area of the lesion at the medial tibial, medial femoral, lateral tibial, and lateral femoral sites. If more than one lesion is present at the same site, BML with the greatest area will be considered. Total bone marrow lesion size will be calculated as the sum of every lesion within each site.
Measured: 24 weeks
Change in whole-organ MRI scoring (WORMS)-Subchondral bone scale
WORMS is a semi-quantitative scoring system based on MRI without intravenous or intra-articular administration of contrast agents. It provides a score based on the extent of marrow involvement present in a subregion. In WORMS, fifteen different regions subdivided by anatomical landmarks in the fully extended knee are assessed. BMLs will be assessed in each of the 14 articular surface regions as well as the region of the tibia beneath the tibial spines (S) from 0 to 3 based on the extent of regional involvement scored as integers from 0 to 3, where 0 = none; 1 = < 25% of the region; 2 =25-50% of the region; and 3 = severe, > 50% of the region. The maximum scores for medial femorotibial joint, medial femorotibial joint, patellofemoral joint and subspinous regrion are 15, 15, 12, and 3 respectively. The total scores of the knee BMLs will be obtained by adding the BML scores of all sites, and the total score range of the knee BMLs = 0-45.
Measured: 12 weeks
Change in whole-organ MRI scoring (WORMS)-Subchondral bone scale
WORMS is a semi-quantitative scoring system based on MRI without intravenous or intra-articular administration of contrast agents. It provides a score based on the extent of marrow involvement present in a subregion. In WORMS, fifteen different regions subdivided by anatomical landmarks in the fully extended knee are assessed. BMLs will be assessed in each of the 14 articular surface regions as well as the region of the tibia beneath the tibial spines (S) from 0 to 3 based on the extent of regional involvement scored as integers from 0 to 3, where 0 = none; 1 = < 25% of the region; 2 =25-50% of the region; and 3 = severe, > 50% of the region. The maximum scores for medial femorotibial joint, medial femorotibial joint, patellofemoral joint and subspinous regrion are 15, 15, 12, and 3 respectively. The total scores of the knee BMLs will be obtained by adding the BML scores of all sites, and the total score range of the knee BMLs = 0-45.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start13 Oct 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow EdemaStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective pilot clinical trial.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- New Jersey Regenerative Institute, LLC
- Responsible party
- Principal investigator, Nathan Hogaboom, PhD, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596591
- Sponsor's protocol ID
- R-1191-22
- Status last verified
- Mar 2026
- First submitted
- 24 Oct 2022
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused Extracorporeal Shockwave Therapy for Subchondral Bone Marrow Lesions in People With Knee Osteoarthritis: A Pilot Study
- ClinicalTrials.gov ID
- NCT05596591
- Acronym / sponsor ID
- R-1191-22
- Conditions
- Bone Marrow Edema, Knee Osteoarthritis, Knee Pain Chronic
- Keywords
- Shockwave Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- New Jersey Regenerative Institute, LLC
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subchondral bone marrow lesions (BMLs) in knee osteoarthritis (OA) are strongly associated with presence and severity of knee pain, structural deterioration, disease progression with an increased risk of total knee arthroplasty. OA-related BMLs may regress or resolve within 30 months which could be associated with long lasting disability. It has been reported that BMLs persist in the majority of knee OA patients. Different treatment strategies have been proposed including rest and protected weight-bearing, bisphosphonates, subchondroplasty and intraosseous orthobiologic injection. However, conservative treatment response takes a long time and other interventions may be considered invasive procedures that show varying results with several side effects. Focused extracorporeal shockwave therapy (f-ESWT) has been established as a safe non-invasive treatment with positive results in different bone disorders that share the same pathological features of BMLs. This is an exploratory, randomized-controlled, pilot study to determine the efficacy and safety of f-ESWT compared to the standard-of-care (analgesics and protected weight bearing) for the treatment of BMLs in patients with knee OA. Thirty subjects with knee OA who have history of knee pain at rest and during walking with the confirmed diagnosis of subchondral BML(s) on magnetic resonance imaging (MRI) despite at least 4 weeks of conservative treatment will be enrolled into this study. Subjects will receive a total of 4 sessions (at high energy level) over 4 consecutive weeks. Participants will be evaluated for adverse events and changes in pain intensity and knee function, using an 11-point numerical rating scale (NRS; 0-10, with anchors "no pain" and "pain as bad as you can imagine") and; the Knee injury and Osteoarthritis Outcome Score, respectively. Subjects will be assessed with these outcome measures at baseline, 1 month, 2 months, 3 months, and 6 months after the treatment. MRI of the involved knee will be performed prior to treatment (baseline) and 3 months and 6 months after treatment.
Detailed description
Background: Subchondral bone marrow lesions (BMLs) in knee osteoarthritis (OA) are strongly associated with presence and severity of knee pain, structural deterioration, disease progression with an increased risk of total knee arthroplasty. OA-related BMLs may regress or resolve within 30 months which could be associated with long lasting disability. It has been reported that BMLs persist in the majority of people with knee OA. Different treatment strategies have been proposed including rest and protected weight-bearing, bisphosphonates, subchondroplasty and intraosseous orthobiologic injection. However, conservative treatment response takes a long time and other interventions may be considered invasive procedures that show varying results with several side effects. Focused extracorporeal shockwave therapy (f-ESWT) has been established as a safe non-invasive treatment with positive results in different bone disorders that share the same pathological features of BMLs.
Objective: This is an exploratory pilot study to determine the efficacy and safety of f-ESWT for the treatment of BMLs in people with knee OA.
Participants: Fifteen subjects with knee OA who have history of knee pain at rest and during walking with the confirmed diagnosis of subchondral BML(s) on magnetic resonance imaging (MRI) despite at least 4 weeks of conservative treatment will be enrolled into this study.
Procedures: Subjects will receive a total of 4 focused ESWT sessions (at high energy level) over 4 consecutive weeks.
Outcome Measures: Participants will be evaluated for adverse events and changes in pain intensity and knee function, using an 11-point numerical rating scale (NRS; 0-10, with anchors "no pain" and "pain as bad as you can imagine") and; the Knee injury and Osteoarthritis Outcome Score (KOOS; five subscales: pain, other symptoms, function in activities of daily living, function in sports and recreation, and knee-related quality of life), respectively. Subjects will be assessed with these outcome measures at baseline, 1 month, 2 months, 3 months, and 6 months after the treatment. MRI of the involved knee will be performed prior to treatment (baseline) and 3 months and 6 months after treatment.
Anticipated Outcomes: Focused extracorporeal shockwave therapy is a safe alternative to treating BMLs and will significantly decrease knee pain intensity and improve function in people with knee OA- related BMLs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective pilot clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Focused extracorporeal shockwave therapyParticipants will receive four sessions over four consecutive weeks (one per week) of focused extracorporeal shockwave therapy. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focused extracorporeal shockwave therapyHigh energy level shockwaves (between 0.28-0.60 mJ/mm^2) will be focused over the subchondral bone with the bone marrow lesion, previously localized on MRI. | Device | Intervention |
Primary outcome
Change in knee pain numerical rating scale scores
Time frame: 12 weeks
Twelve-week knee pain intensity will be assessed using NRS. Subjects will be asked to rate their average pain, most severe pain, and least severe pain using an 11-point scale (i.e. 0-10) anchored at the ends by "no pain" and "pain as bad as you can imagine." NRS allows comparison across clinical trials of chronic pain treatment and is recommended as a core outcome measure for chronic pain clinical trials.
9 secondary outcomes
Change in knee pain numerical rating scale scores
Time frame: 8 weeks
Change in knee pain numerical rating scale scores
Time frame: 24 weeks
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 8 weeks
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 12 weeks
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 24 weeks
Change in bone marrow lesion area
Time frame: 12 weeks
Change in bone marrow lesion area
Time frame: 24 weeks
Change in whole-organ MRI scoring (WORMS)-Subchondral bone scale
Time frame: 12 weeks
Change in whole-organ MRI scoring (WORMS)-Subchondral bone scale
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
Related trials for Bone Marrow Edema
Recruiting
Extracorporeal Shock Wave Therapy in the Treatment of Periarticular Bone Marrow Edema in Patients With Knee Osteoarthritis
Knee Arthritis, Osteoarthritis, Bone Marrow Edema of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused extracorporeal shockwave therapy in people with Bone Marrow Edema and Knee Osteoarthritis, run by Kessler Foundation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathan Hogaboom, PhD (9733243584, nhogaboom@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in knee pain numerical rating scale scores (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.