Actively Recruiting
Treatment of Post Traumatic Knee Osteoarthritis With Extracorporeal Shockwave Therapy
Led by Spaulding Rehabilitation Hospital · Updated on 2025-12-04
70
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying current or former athletes who had ACL reconstruction surgery over a year ago and now have knee osteoarthritis (OA). The study aims to explore how extracorporeal shockwave therapy (ESWT) affects pain, function, knee movement, strength, inflammation, and joint health in this group. This research is a randomized, placebo-controlled trial focused on understanding ESWT's impact on post-traumatic osteoarthritis after ACL surgery. Participants will be randomly assigned to receive either ESWT or a sham (placebo) treatment. Those in the ESWT group will get shockwave therapy using specialized devices applied to specific knee and leg areas over three visits spaced about a week apart. The sham group will undergo a similar procedure without actual shockwaves, with sound effects mimicking treatment to maintain blinding. Both groups will follow a prescribed home exercise program as part of standard care. Throughout the study, participants will undergo various assessments including gait analysis, thermal imaging, bioimpedance, knee range of motion, strength tests, MRI, X-rays, and blood tests to measure inflammation and biomarkers. Surveys on pain and function will be collected before, during, and after treatment at several time points up to four months. Those initially in the sham group may opt to receive ESWT later. Total involvement lasts between four to eight months depending on group assignment and crossover participation.
CONDITIONS
Brief Title
Treatment of Post Traumatic Knee Osteoarthritis With Extracorporeal Shockwave Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previous ACL reconstruction using an autograft or allograft in the knee with post-traumatic osteoarthritis
- At least one year has passed since ACL reconstruction surgery
- Age between 18 and 55 years
- No mechanical symptoms or contraindications limiting ability to complete the study protocol
- Knee Injury and Osteoarthritis Outcome Score (KOOS) of 85 or lower in at least 2 of 4 domains (pain, symptoms, activities of daily living, quality of life)
- Primary pain is from the knee
- Diagnosis of post-traumatic osteoarthritis confirmed by clinical and radiographic evidence prior to enrollment
You will not qualify if you...
- Received injections to the knee joint within the past 3 months
- Women who are pregnant or planning pregnancy
- Neuropathy affecting pain sensation
- Known cardiac disease that could be impacted by shockwave therapy
- Chronic rheumatological conditions, immunodeficiency, severe asthma requiring more than inhalers, connective tissue disorders, active malignancy, or other medical conditions affecting inflammation
- Neuropathy diagnosis affecting pain response
- Use of oral steroids or anti-inflammatories at enrollment
- Bilateral ACL injury or reconstruction, or ACL revision surgery
- Active malignancy or less than five years in remission
- Previous extracorporeal shockwave therapy treatment for knee osteoarthritis using study devices
- Presence of pacemaker, bone screws, or metal implants preventing MRI or ESWT
- Non-English speaking individuals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 to 3 baseline visits (in-person) to complete assessments including gait biomechanics, thermal imaging, bioimpedance, knee range of motion, strength tests, bone density scans, X-rays, MRI, blood draws, and questionnaires.
Duration - Approximately 3 weeks (three treatment visits separated by about one week each)
Participants receive either extracorporeal shockwave therapy (ESWT) or sham ESWT treatment in three sessions. Treatments are administered using specialized devices with measures taken before each session including blood draws. Participants also follow a prescribed post-treatment exercise program.
3 treatment visits (in-person), each including treatment and blood draws prior to treatment.
Duration - Up to 4 months after starting treatment
Participants complete follow-up assessments to evaluate changes in knee function, pain, biomechanics, imaging, and biomarkers. Questionnaires are completed at 8 weeks and 4 months after initial treatment. Repeat imaging and physical assessments are performed at 4 months.
1 visit at 4 months (in-person) and questionnaires completed electronically at 8 weeks and 4 months.
Duration - Additional 3 weeks for cross-over treatment
Participants initially assigned to the sham treatment may elect to receive ESWT treatment consisting of three additional treatment sessions with associated assessments.
Up to 12 total visits including cross-over, with 3 additional treatment visits if cross-over is elected.
Trial Site Locations
Total: 1 location
1
Spaulding Cambridge Hospital
Cambridge, Massachusetts, United States, 02138
Actively Recruiting
Research Team
A
Adam S Tenforde, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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