Treatment for knee osteoarthritis using shockwave therapy
Treatment of Post Traumatic Knee Osteoarthritis With Extracorporeal Shockwave Therapy
This study is testing if shockwave therapy can help people with knee osteoarthritis after ACL surgery feel less pain and move better compared to those who receive a fake treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Spaulding Rehabilitation Hospital Academic / other |
| Locations | 1 site (Cambridge, Massachusetts) |
| Trial ID | NCT06686680 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of extracorporeal shockwave therapy (ESWT) on individuals with post-traumatic knee osteoarthritis (PTOA) who have previously undergone ACL reconstruction surgery. Participants will be assessed for improvements in pain, function, biomechanics, and joint health following treatment. The study aims to compare outcomes between those receiving ESWT and a sham treatment group, focusing on functional outcomes, gait biomechanics, and inflammation levels in the knee. The research seeks to provide insights into the potential benefits of ESWT for enhancing recovery in this patient population.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 55 who have mild to moderate PTOA and have undergone ACL reconstruction at least one year prior.
Not a fit: Patients with recent knee injections, pregnancy, or underlying cardiac disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve pain management and functional outcomes for patients with knee osteoarthritis following ACL injuries.
How similar studies have performed: While the use of ESWT has shown promise in other conditions, its application in post-traumatic knee osteoarthritis is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cambridge, Massachusetts
- Spaulding Cambridge Hospital — Cambridge, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Adam S Tenforde, MD
- Email: atenforde@mgh.harvard.edu
- Phone: (617) 952-6800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.