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Treatment of Post Traumatic Knee Osteoarthritis With Extracorporeal Shockwave Therapy

Sponsor: Spaulding Rehabilitation Hospital • ClinicalTrials.gov ID: NCT06686680

Registry updated: 2026-09-25

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Description

This study is recruiting current or former athletes who had ACL reconstruction surgery over a year ago and have been diagnosed with knee osteoarthritis (OA). We are doing the research to investigate the effects of extracorporeal shockwave therapy (ESWT) on pain, function, biomechanics, knee range of motion and strength, inflammation, and joint structure and integrity of the knee.

Interventions

extracorporeal shockwave therapy (ESWT) (Device)
Participants will receive ESWT administered by research personnel, using the OrthoPlus Ultra 100/radial D-Actor and Duolith SD1 T-top focus.Radial pressure waves will be applied using the Extracorporeal Pressure Activation Treatment (EPAT) device. For the anterior knee, patella tendon, vastus lateralis, and vastus medialis, treatment will aim for 1500 strikes at induction dose of 1.5 bars and titrating up by 0.5 bars to 3 bars and this will be performed to participant tolerance to pain, as pain is experienced due to clinical focusing technique which is standard of care in delivering effective treatment. For the calf muscles, the patient will be positioned prone and a similar protocol of starting at 1.5 and titrating up as tolerated to 3 bars. Focused shockwave therapy will be applied for 1000 shocks to four anatomical locations for a total of 4000 shocks. Each site will receive 1000 shocks: medial and lateral tibial plateau and medial and lateral femoral condyle.
Sham Comparator (Device)
All participants will review the exercise program prior to randomization and receiving sham ESWT treatment. The standard operating procedures for ESWT will be followed and will include review of procedure protocol and post-procedure care. Participants will come into the office for three treatment visits separated by seven days +/- 7 day. Sham ESWT will administered by trained research personnel, using the OrthoPlus Ultra 100/radial D-Actor and Duolith SD1 T-Top focused shockwave devices. The device will be placed on the same landmarks as that of the ESWT treatment group; however, no shockwaves will be administered; rather, an audio recording that mimics the sound of shockwave will be played. A curtain will obscure participants from viewing their knee and the device to blind them from treatment they are receiving.

Eligibility criteria

Inclusion Criteria: * Previous ACL reconstruction using an autograft or allograft in the knee with PTOA * Minimum of one year following ACL reconstruction surgery * Between ages of 18 and 55 * No clear contraindication to complete protocol including mechanical symptoms which would limit ability to complete the study * Score on KOOS for 2 of 4 domains (pain, symptoms, activities of daily living (ADL), quality of life (QOL)) of 85 or lower * Primary pain is coming from the knee * Diagnosis of PTOA based on clinical diagnosis and confirmation with radiographic evidence by a medical professional prior to study enrollment. If individuals have suspected OA based on impairments such as pain, they must have a score on KOOS for 2 of 4 domains (pain, symptoms, activities of daily living (ADL), quality of life (QOL)) of 85 or lower to participate in the study. Exclusion Criteria: * Have previously received injections to the knee joint within the past 3 months * Women who are pregnant or those who are planning to become pregnant. This is due to the fact that pregnancy will reduce participants activity after the treatment and the safety concerns related to shockwave treatment. - Participants with neuropathy affecting sensation to pain * Participants with a known underlying cardiac disease that could be affected by shockwave therapy * Chronic rheumatological conditions, immunodeficiency, severe asthma, connective tissue disorder (i.e. Ehlers-Danlos Syndrome), or other medical conditions (ex. active malignancy, severe asthma) outside of PTOA that are known to impact inflammatory state or requiring chronic use of oral or intravenous immune modulatory medications. Asthma requiring use of inhalers only is not an exclusion criteria * Neuropathy diagnosis that can affect response to pain * No active use of oral steroids or anti-inflammatories at the time of enrollment * Have bilateral ACL injury or reconstruction surgery, or have had ACL revision surgery * No active malignancy and at least five years in remission * Previous ESWT treatment using study treatment devices for management of knee osteoarthritis * Have a pacemaker, bone screws, or any other metal implants that would prohibit participation in an MRI scan or EWST * Non-English speaking individuals

Conditions

Knee Osteoarthristis ACL Injuries Post-Traumatic

Locations

Spaulding Cambridge Hospital — Cambridge, Massachusetts, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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