Treatment of Post Traumatic Knee Osteoarthritis With Extracorporeal Shockwave Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorSpaulding Rehabilitation Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
extracorporeal shockwave therapy (ESWT)
DeviceParticipants 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
DeviceAll 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Control Group: Sham ESWT ArmSham comparator 1 intervention
Group B: Treatment Group: ESWT ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is is a 42-item survey with 5 subscales designed to measure patient health, symptoms, and functionality of the knee. It is scored from 0-100, with higher score correlated with better function.
Time frame
From baseline to 4-month follow up with intermediate measure at 8 weeksSecondary outcomes
1
Biomarkers of oxidative stress and inflammation
Biomarkers of oxidative stress and inflammation (for example, interleukins, MMPs, C-reactive protein) and other candidate biomarkers of interest such as Klotho and Eotaxin will be collected.
Time frame
Baseline, at each of the three treatment sessions and at 4 months2
Biomechanics
Lower extremity biomechanics will be collected on an instrumented treadmill and overground using motion capture and EMG with participants walking and running at both lab and self-selected speeds.
Time frame
Baseline and 4 months3
Knee range of motion
Maximum knee extension and knee flexion range of motion will be measured with a goniometer.
Time frame
Baseline and 4 months4
Quadriceps strength and power
All quadriceps testing (in 90° of knee flexion) for both limbs will be performed isometrically using hand-held dynamometry (HHD). For each task, a participant will be positioned with the HHD and taken through a series of sub-maximal contractions to allow for warm-up and acclimation. The warm-up will consist of contractions at 50, 75 and 100% of their self-perceived maximal isometric contraction with one minute of rest between each contraction.
Time frame
Baseline and 4 monthsSponsors and contacts
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Source ClinicalTrials.gov