Treatment of Post Traumatic Knee Osteoarthritis With Extracorporeal Shockwave Therapy
Spaulding Rehabilitation Hospital
Summary
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.
Description
The goal of this study is to characterize redox homeostasis in post-traumatic osteoarthritis (PTOA), with the goal of examining the impact of extracorporeal shockwave therapy (ESWT). We will explore the following aims: Specific Aim 1: Investigate the effects of ESWT treatment on participant-reported functional outcomes and quality of life in individuals with PTOA of the knee. We hypothesize that those in ESWT group will report greater improvements in pain level, function and quality of life compared to those individuals in the sham group. Specific Aim 2: Determine if ESWT influences gait bio…
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Deviceextracorporeal shockwave therapy (ESWT)
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.
- DeviceSham Comparator
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.
Location
- Spaulding Cambridge HospitalCambridge, Massachusetts