Focused Extracorporeal Shockwave Therapy for Knee Arthritis

NCT05596591 | Recruiting FDA Device

• 1 other identifier: R-1191-22
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Bone Marrow Edema; Knee Osteoarthritis; Knee Pain Chronic

Keywords

Shockwave Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (9)

• Change in knee pain numerical rating scale scores

  8 weeks

• Change in knee pain numerical rating scale scores

  24 weeks

• Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)

  8 weeks

• Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)

  12 weeks

• Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)

  24 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Participants will receive four sessions over four consecutive weeks (one per week) of focused extracorporeal shockwave therapy.

Device: Focused extracorporeal shockwave therapy

Interventions

Focused extracorporeal shockwave therapy DEVICE

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.

Intervention

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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; 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.

You may not qualify 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.
• Prior treatment for BMLs including:
• 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:
• years (if use \> 48 weeks).
• year (if used \> 8 weeks but \< 48 weeks)
• months (if used \> 2 weeks but \< 8 weeks)
• months (if used \< 2 weeks)
• Any intravenous bisphosphonate within the prior 2 years.
• Intra-articular steroid injection in the prior 3 months.

Sponsors & Collaborators

• New Jersey Regenerative Institute, LLC: collaborator
• Kessler Foundation: lead

Study Sites (2)

New Jersey Regenerative Institute

Cedar Knolls, New Jersey, 07927, United States

RECRUITING

Nathan Hogaboom

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Nathan Hogaboom, PhD

CONTACT

9733243584; nhogaboom@kesslerfoundation.org

Shalaka Paranjpe, MS

CONTACT

9733246643; sparanjpe@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: Prospective pilot clinical trial.

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 27, 2022
• Study Start: October 13, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (2)