NCT06686680 Treatment of Post Traumatic Knee Osteoarthritis With Extracorporeal Shockwave Therapy
| NCT ID | NCT06686680 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Spaulding Rehabilitation Hospital |
| Condition | Knee Osteoarthristis |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2025-04-01 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06686680 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Knee Osteoarthristis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06686680 currently recruiting?
Yes, NCT06686680 is actively recruiting participants. Contact the research team at atenforde@mgh.harvard.edu for enrollment information.
Where is the NCT06686680 trial being conducted?
This trial is being conducted at Cambridge, United States.
Who is sponsoring the NCT06686680 clinical trial?
NCT06686680 is sponsored by Spaulding Rehabilitation Hospital. The trial plans to enroll 70 participants.