Shockwave Therapy for Knee Arthritis

(PTOA Knee Trial)

Overseen By Adam S Tenforde, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Spaulding Rehabilitation Hospital

Must not be taking: Oral steroids, Anti-inflammatories

Disqualifiers: Pregnancy, Cardiac disease, Neuropathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 3 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if extracorporeal shockwave therapy (ESWT) can improve knee pain and function in individuals with knee osteoarthritis (OA), particularly those who underwent ACL reconstruction surgery over a year ago. Researchers seek to assess the treatment's impact on pain, knee movement, and overall knee health. Participants will be divided into two groups: one receiving actual ESWT and the other receiving a sham treatment that mimics the real one. Individuals experiencing knee pain after ACL surgery and diagnosed with knee OA may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore a potentially beneficial treatment for knee OA and post-ACL surgery pain.

Will I have to stop taking my current medications?

The trial requires that you are not actively using oral steroids or anti-inflammatory medications at the time of enrollment.

What prior data suggests that extracorporeal shockwave therapy is safe for knee osteoarthritis?

Research has shown that extracorporeal shockwave therapy (ESWT) is generally safe for people with knee osteoarthritis. Studies have found that ESWT can reduce pain and improve knee function without increasing the risk of side effects, indicating that most people tolerate the treatment well. The therapy sends sound waves to the knee, which can alleviate symptoms like swelling and stiffness.

Previous findings suggest that ESWT might be a good option for those experiencing knee pain from osteoarthritis, especially if they have had ACL surgery before. Although ESWT is not a new treatment, discussing any concerns with a doctor before starting it is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about extracorporeal shockwave therapy (ESWT) for knee arthritis because it offers a non-invasive option that directly targets the affected area with mechanical energy. Unlike standard treatments such as pain relievers and physical therapy, ESWT stimulates tissue repair and reduces inflammation at the cellular level. This method not only avoids the systemic side effects associated with medications but also potentially enhances the body's natural healing processes, offering hope for more effective pain relief and improved joint function.

What evidence suggests that shockwave therapy is effective for knee arthritis?

This trial will compare the effects of extracorporeal shockwave therapy (ESWT) with a sham ESWT treatment for knee osteoarthritis (OA). Research has shown that ESWT effectively treats knee OA, with studies finding significant reductions in knee pain and improvements in knee function. Higher energy levels and more shockwaves typically lead to better outcomes. One study found that focused ESWT was more effective than radial ESWT in reducing pain and enhancing physical function. Overall, ESWT appears to be a promising treatment for improving the quality of life for those with knee OA. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for current or former athletes who had ACL reconstruction surgery over a year ago and now have knee osteoarthritis. Participants should be diagnosed with post-traumatic knee OA to qualify.

Inclusion Criteria

My main source of pain is my knee.

It has been at least a year since my ACL surgery.

No clear contraindication to complete protocol including mechanical symptoms which would limit ability to complete the study

Exclusion Criteria

I am not currently taking any oral steroids or anti-inflammatory medications.

I have a chronic condition like severe asthma or an immune disorder that affects my inflammation.

I have a nerve condition that changes how I feel pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline assessments including biomechanical assessment, thermal imaging, bioimpedance, knee range of motion, quadriceps strength, and MRI of the knee.

1-2 weeks

2-3 visits (in-person)

Treatment

Participants receive ESWT or sham ESWT treatment over three sessions, with blood draws and biomarker analysis.

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with repeat assessments at 8 weeks and 4 months.

4 months

2 visits (in-person), 1 visit (virtual)

Optional Cross-over

Participants in the sham ESWT group have the option to cross-over and receive ESWT treatment.

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Extracorporeal Shockwave Therapy

Trial Overview The study investigates the effects of extracorporeal shockwave therapy (ESWT) on pain, function, biomechanics, and joint health in knees affected by osteoarthritis compared to a sham treatment.

How Is the Trial Designed?

Group I: Treatment Group: ESWT Arm Experimental Treatment 1 Intervention

All participants will review the exercise program prior to randomization and receiving treatment. Participants in the ESWT group will receive ESWT. The standard operating procedures for ESWT will be followed and will include review of procedure protocol and post-procedure care. Radial and focused shockwave will be delivered to the knee and lower leg landmarks. The energy settings that will be used are consistent with mild to moderate ESWT which are commonly used in clinical practice to treat knee OA. During the ESWT treatment, a curtain will obscure participants from viewing their leg to blind them from treatment they are receiving. Standard protocol for the ESWT procedure will be followed, including safety assessment and monitoring. Additionally, the patient will be prescribed a post-ESWT exercise protocol that is part of the standard of care, which will be reviewed prior to first treatment and before treatment allocation is decided to minimize risk of bias.

Group II: Control Group: Sham ESWT Arm Placebo Group 1 Intervention

All participants will review the exercise program prior to randomization and receiving sham ESWT treatment. The standard operating procedures for ESWT will be followed and will include review of procedure protocol and post-procedure care. Participants will come into the office for three treatment visits separated by seven days +/- 7 days to account for ongoing challenges for respiratory illness and scheduling/traveling conflicts. After collecting baseline variables and after blood is drawn, they will receive sham ESWT administered by trained research personnel, using the OrthoPlus Ultra 100/radial D-Actor and Duolith SD1 T-Top focused shockwave devices. The device will be placed on the same landmarks as that of the ESWT treatment group; however, no shockwaves will be administered; rather, an audio recording that mimics the sound of shockwave will be played. A curtain will obscure participants from viewing their knee and the device to blind them from treatment they are receiving.

Extracorporeal Shockwave Therapy is already approved in United States for the following indications:

Approved in United States as ESWT for:

• Chronic plantar fasciitis
• Lateral epicondylitis of the elbow

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Recruited

11,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11020044/

The efficacy of extracorporeal shock wave therapy for knee ... Conclusion: Based on the results of our analysis, ESWT is now an effective therapy for improving pain and function in patients with KOA.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0972978X24001594

A systematic review of the use of shockwave therapy ... This review demonstrated that ESWT was effective for knee OA. Higher energy and more shock numbers could obtain better efficacy.

3. nature.com nature.com/articles/s41598-024-67511-x

Effectiveness of extracorporeal shock wave therapy on ... In these two studies, Shenouda et al. reported a positive impact of ESWT on reducing knee pain and improving functional status, while the latter ...

4. journals.lww.com journals.lww.com/international-journal-of-surgery/fulltext/2024/04000/the_efficacy_of_extracorporeal_shock_wave_therapy.50.aspx

The efficacy of extracorporeal shock wave therapy for knee... Conclusion: Based on the results of our analysis, ESWT is now an effective therapy for improving pain and function in patients with KOA.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35897371/

Comparative Effectiveness of Focused Extracorporeal ... Our results showed that f-ESWT was more effective than r-ESWT in improving pain and physical function in patients with knee osteoarthritis.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10659666/

Effects of extracorporeal shockwave therapy for mild knee ... Our results suggest that ESWT may be effective in reducing suprapatellar effusion and improving symptoms in mild knee OA.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1743919120300273

The efficacy and safety of extracorporeal shockwave ... The ESWT was efficacious and safe for reducing pain and improving knee function in patients with knee osteoarthritis, without increasing the risk of adverse ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06686680

Treatment of Post Traumatic Knee Osteoarthritis With ... We are doing the research to investigate the effects of extracorporeal shockwave therapy (ESWT) on pain, function, biomechanics, knee range of motion and ...