Focused Shockwave Therapy for Knee Pain

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Focused Shockwave (FSW) therapy can reduce knee pain after surgery for a torn ACL, using a specific type of graft. The study compares the effects of real FSW therapy to a placebo (fake treatment) over three weekly sessions. It suits adults who have undergone ACL surgery with certain grafts and have not previously tried similar shockwave treatments. Participants must speak English and provide consent. As an unphased trial, this study offers a unique opportunity to explore a new treatment option that could potentially improve recovery outcomes.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Focused Shockwave therapy is safe for knee pain treatment?

Research has shown that Focused Shockwave Therapy (FSW) is generally safe for treating knee pain. Studies have found that patients usually tolerate FSW well, with optimal results from three sessions spaced a week apart. Each session involves 2000 impulses and is considered both effective and safe.

Most patients experience significant improvement in pain and movement, with up to 80% reporting positive results. Side effects are rare and typically mild, such as slight discomfort during treatment. Overall, FSW is regarded as a safe method to reduce knee pain after surgery.12345

Why are researchers excited about this trial?

Most treatments for knee pain involve medication, physical therapy, or surgery. But focused shockwave therapy (FSW) works differently, targeting pain by sending high-energy sound waves to the affected area. Unlike traditional treatments that may take longer to provide relief, FSW has the potential to improve symptoms after just a few sessions. Researchers are excited because this non-invasive therapy could offer a quicker, drug-free alternative for managing knee pain, minimizing the need for more invasive procedures.

What evidence suggests that Focused Shockwave therapy is effective for reducing knee pain after ACL reconstruction?

This trial will compare Focused Shockwave Therapy (FSWT) with a sham treatment to evaluate its effectiveness in reducing knee pain. Studies have shown that FSWT can effectively reduce knee pain and improve knee function. Specifically, in people with knee osteoarthritis, FSWT led to a 45% decrease in pain after 12 weeks, outperforming groups that did not receive this treatment. This therapy sends shockwaves to the painful area, potentially aiding healing and reducing swelling. Research also shows that FSWT can enhance knee function, as evidenced by improved scores on tests measuring knee stability and movement. These findings suggest FSWT could be promising for reducing knee pain after ACL surgery.16789

Who Is on the Research Team?

JM

Joshua M. Romero, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults 18 or older who have had their ACL repaired using either a patellar tendon or quadriceps tendon graft, have not previously received shockwave treatments, can give consent, and speak English.

Inclusion Criteria

I am 18 years old or older.
I have had ACL reconstruction using my own patellar or quadriceps tendon.
Must speak English
See 2 more

Exclusion Criteria

Pregnant or breastfeeding
I have had surgery on this same knee before.
I have had a blood clot in a deep vein before.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Focused shockwave (FSW) therapy or sham therapy applied to the autograft harvest site for 3 consecutive weekly sessions

3 weeks
3 visits (in-person)

Follow-up

Participants are monitored for changes in knee function and pain using various scales

12 months
Multiple visits at 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Focused Shockwave

Trial Overview

The study compares focused shockwave therapy to a sham (placebo) treatment to see if it helps reduce front knee pain after ACL reconstruction surgery. Participants are randomly assigned to one of the two groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Focused shockwaveExperimental Treatment1 Intervention
Group II: Sham focused shockwavePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

The Efficacy of Focused Extracorporeal Shockwave Therapy ...

We found that focused shockwave use can appropriately rehabilitate the knee function and reduce knee osteoarthritis pain. Further studies to ...

A Study Of Focused Shockwave For Anterior Knee Pain ...

The purpose of this study is to investigate whether Focused Shockwave (FSW) therapy reduces anterior knee pain following anterior cruciate ligament ...

a pilot study | Journal of Rehabilitation Medicine

To evaluate the effect of different dosage parameters of focused-extracorporeal shock wave therapy on pain and physical function in knee ...

Comparing Shockwave vs Injection-Based Regenerative ...

A meta-analysis of nine RCTs showed ESWT more than doubled success rates in chronic plantar fasciitis, with sustained improvements and no adverse events (Sun et ...

A Study Of Focused Shockwave For Anterior Knee Pain ...

The purpose of this study is to investigate whether Focused Shockwave (FSW) therapy reduces anterior knee pain following anterior cruciate ...

Efficacy and safety of extracorporeal shock wave therapy for ...

ESWT is effective and safe. An optimum treatment protocol for ESWT appears to be three treatment sessions at 1-week intervals, with 2000 impulses per session ...

Effects of Focused Extracorporeal Shock Wave Therapy in ...

Summary: ESWT treatment significantly reduces prevalence and severity of anterior knee pain after ACLR using BTB autograft. ?Purpose?Anterior knee pain (AKP) is ...

A Study Of Focused Shockwave For Anterior Knee Pain ...

About this study. The purpose of this study is to investigate whether Focused Shockwave (FSW) therapy reduces anterior knee pain following anterior cruciate ...

Focused Shockwave Therapy for Knee Pain

The purpose of this study is to investigate whether Focused Shockwave (FSW) therapy reduces anterior knee pain following anterior cruciate ligament ...