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New treatment option for Knee Osteoarthristis
Official title Treatment of Post Traumatic Knee Osteoarthritis With Extracorporeal Shockwave Therapy
ClinicalTrials.gov ID: NCT06686680
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
- Neuropathy diagnosis that can affect response to pain
- No active use of oral steroids or anti-inflammatories at the time of enrollment
See the full eligibility 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...
- 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 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cambridge, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cambridge, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.