Focused Extracorporeal Shockwave Therapy for Knee Arthritis

Part of paid clinical trials in Cedar Knolls, New Jersey.

Sponsor
Kessler Foundation
Study ID
NCT05596591
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 80 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Oct 13, 2022
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Change in knee pain numerical rating scale scores [ Time Frame: 12 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
New Jersey Regenerative InstituteCedar KnollsNew Jersey07927
Jay Bowen, DO
973-998-8309
Nathan HogaboomWest OrangeNew Jersey07052
Nathan Hogaboom, PhD
[email protected]
9733243584
Shalaka Paranjpe, MS
[email protected]
9739656643

Find similar trials in Cedar Knolls, NJ

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
New Jersey Regenerative Institute· Cedar Knolls, NJNathan Hogaboom· West Orange, NJ

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