Shockwave Therapy for Chronic Knee Pain

Recruiting at 2 trial locations

Overseen By Jay Bowen, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Must not be taking: Glucocorticoids, Bisphosphonates

Disqualifiers: Autoimmune diseases, Bilateral BMLs, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment for chronic knee pain caused by bone marrow lesions (BMLs) in osteoarthritis patients. It compares focused extracorporeal shockwave therapy, a non-invasive treatment using sound waves, to standard care such as painkillers and limited movement. The goal is to determine if this new method can safely reduce pain and improve knee function more effectively than usual treatments. Individuals who continue to experience knee pain after at least four weeks of conservative treatment might be suitable candidates for this trial. As an unphased trial, it offers patients the opportunity to explore innovative treatments that could potentially enhance their quality of life.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop all current medications. However, if you have used bisphosphonates, there is a required washout period based on how long you used them. Also, you cannot participate if you are currently receiving glucocorticoids or have had an intra-articular steroid injection in the last 3 months.

What prior data suggests that this shockwave therapy is safe for treating knee pain?

Research has shown that focused extracorporeal shockwave therapy (f-ESWT) is generally safe and well-tolerated for treating knee problems. In various studies, patients reported less pain and improved knee function within 12 weeks of treatment. This therapy has been used for different bone and ligament issues, aiding in pain relief and healing without major side effects.

Previous findings indicate that f-ESWT is a non-invasive treatment, meaning it doesn't involve surgery or other procedures that enter the body. This makes it an appealing option for people with knee osteoarthritis, as it avoids the risks associated with more invasive treatments. Overall, existing evidence supports the safety of f-ESWT for similar conditions, suggesting it is a promising choice for managing knee pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Focused Extracorporeal Shockwave Therapy (ESWT) is unique because it offers a non-invasive approach to treating chronic knee pain, unlike the standard options like pain relievers, physical therapy, or surgeries. This therapy uses pressure waves to stimulate healing in the affected area, potentially enhancing tissue repair and reducing inflammation. Researchers are excited about ESWT because it targets the knee pain directly and could provide relief without the need for medication or invasive procedures. Additionally, its promise of fewer side effects and quicker recovery makes it a compelling option for those suffering from chronic knee pain.

What evidence suggests that focused extracorporeal shockwave therapy is effective for chronic knee pain?

Studies have shown that focused extracorporeal shockwave therapy (f-ESWT), which participants in this trial will receive, can reduce pain and improve knee function in people with knee osteoarthritis (OA). Research suggests that this therapy decreases knee swelling and enhances overall movement. One study found that f-ESWT relieves pain and aids physical activities more effectively than some other types of shockwave therapy. Another review concluded that higher energy levels in the treatment can lead to better results. Overall, these findings suggest that f-ESWT could be a promising option for those with painful knee OA. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for men and women aged 30-80 with knee pain from osteoarthritis, confirmed by MRI to have bone marrow lesions. They should have tried conservative treatments like rest and analgesics for at least 4 weeks without success. People with severe coagulopathy, tumors in the treatment area, recent knee surgery or injections, metal implants incompatible with MRI, pregnancy, or autoimmune diseases cannot participate.

Inclusion Criteria

I've tried basic treatments like rest and pain relief for over 4 weeks without improvement.

I am between 30 and 80 years old.

My MRI shows bone marrow lesions in the knee's weight-bearing areas.

Exclusion Criteria

I haven't had treatments like PRP or bone marrow injections in my knee in the last 6 months.

I have a systemic autoimmune disease like lupus or rheumatoid arthritis.

Contraindications to MRI scanning including presence of metal implants such as implanted pacemaker, metal sutures, metallic protheses (including metal pins and rods, heart valves), presence of shrapnel or iron filings in the eye, magnetic dental implants, cochlear implants, cerebral aneurysm clip, and deep brain stimulator, claustrophobia, the patient has been informed by his/her doctor that it is medically unsafe to receive regular MRI as part of his/her medical care

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either focused extracorporeal shockwave therapy (f-ESWT) or standard of care treatment over 4 weeks

4 weeks

4 sessions (in-person) for f-ESWT group

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1, 2, 3, and 6 months

6 months

Assessments at 1, 2, 3, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Focused Extracorporeal Shockwave Therapy

Trial Overview

The study tests focused extracorporeal shockwave therapy (f-ESWT) against standard care (analgesics and non-weight bearing) for treating bone marrow lesions in knee osteoarthritis. Thirty participants will be randomly assigned to receive either f-ESWT over four sessions or standard care. Pain intensity and knee function will be measured over six months using scales and MRIs.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Participants will receive four sessions over four consecutive weeks (one per week) of focused extracorporeal shockwave therapy.

Focused Extracorporeal Shockwave Therapy is already approved in European Union, United States, Canada, China for the following indications:

Approved in European Union as ESWT for:

• Knee osteoarthritis
• Subchondral bone marrow lesions

Approved in United States as ESWT for:

• Knee osteoarthritis
• Subchondral bone marrow lesions

Approved in Canada as ESWT for:

• Knee osteoarthritis
• Subchondral bone marrow lesions

Approved in China as ESWT for:

• Knee osteoarthritis
• Subchondral bone marrow lesions

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

New Jersey Regenerative Institute, LLC

Industry Sponsor

Trials

2

Recruited

50+

Published Research Related to This Trial

Extracorporeal shockwave therapy (ESWT) significantly reduced pain and improved knee function in patients with osteoarthritis over a 12-week period, showing better results than placebo with no reported adverse events.

Patients receiving ESWT experienced a notable decrease in pain scores on the visual analog scale, from 7.56 at baseline to 3.83 at 12 weeks, indicating its efficacy in managing knee osteoarthritis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of extracorporeal shockwave therapy for knee osteoarthritis: a randomized controlled trial. Zhao, Z., Jing, R., Shi, Z., et al.[2022]

In a study of 284 patients with plantar fasciitis, 76% of those who received a single session of extracorporeal shockwave therapy (ESWT) reported satisfactory pain relief, similar to the 74% satisfaction rate among those who received multiple sessions, indicating that a single treatment may often be sufficient.

The results suggest that while repeated ESWT may help reduce healing time for some patients, many can achieve significant pain relief with just one session, highlighting the need for further research on optimal treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approaches to optimize focused extracorporeal shockwave therapy (ESWT) based on an observational study of 363 feet with recalcitrant plantar fasciitis. Scheuer, R., Friedrich, M., Hahne, J., et al.[2020]

Extracorporeal shockwave therapy (ESWT) significantly reduces pain in patients with knee osteoarthritis, showing lower pain scores both two weeks and six months after treatment compared to control groups, based on a meta-analysis of nine studies with 705 patients.

ESWT also improves functional outcomes in knee OA, with better results observed four to six weeks post-treatment, and no rebound pain was reported for up to 12 months, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extracorporeal shockwave therapy for the treatment of knee osteoarthritis: a meta-analysis. Hsieh, CK., Chang, CJ., Liu, ZW., et al.[2021]

Extracorporeal shock-wave therapy (ESWT) significantly improves treatment success rates, pain reduction, and restoration of knee range of motion in patients with knee soft tissue disorders, based on a meta-analysis of 19 high-quality randomized controlled trials.

Focused shock-wave therapy (FoSWT) and radial shock-wave therapy (RaSWT) both show effectiveness, particularly when applied for longer durations, but their efficacy varies with energy levels, suggesting that treatment protocols may need to be tailored for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of extracorporeal shock wave therapy for knee tendinopathies and other soft tissue disorders: a meta-analysis of randomized controlled trials. Liao, CD., Xie, GM., Tsauo, JY., et al.[2022]

Extracorporeal shock wave therapy (ESWT) significantly reduced pain and improved knee function in patients with knee osteoarthritis (KOA), with notable improvements observed at 4, 8, and 12 weeks after treatment.

The therapeutic effects of ESWT may peak around 8 weeks post-treatment, although its efficacy was not statistically superior to that of nonsteroidal anti-inflammatory drugs (NSAIDs) in this study involving 82 ESWT patients and 104 NSAID patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of extracorporeal shock wave therapy on the treatment of moderate to severe knee osteoarthritis and cartilage lesion. Xu, Y., Wu, K., Liu, Y., et al.[2022]

This retrospective study aimed to evaluate the effectiveness of extracorporeal shockwave therapy (ESWT) compared to sham treatment in patients with knee osteoarthritis, focusing on pain relief and physical function.

The study was conducted at Ruijin Hospital and included patients diagnosed with knee osteoarthritis from 2016 to 2017, but specific results on efficacy and adverse effects were not provided in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of extracorporeal shock wave therapy in patients with knee osteoarthritis: A cohort study protocol. Xie, X., Zhu, J., Zhang, H.[2022]

Focused extracorporeal shock wave therapy (fESWT) can effectively reduce heel pain in cancer patients, as demonstrated in a case study of a 75-year-old woman with breast cancer and metastatic bone disease, who experienced an 80% reduction in pain after treatment.

The treatment was administered safely with no adverse events reported, suggesting that fESWT may be a viable option for managing conditions like plantar fasciitis in patients with cancer, provided that certain precautions are taken.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful application of focused extracorporeal shockwave therapy for plantar fasciitis in patients suffering from metastatic breast cancer. Zdravkovic, A., Mickel, M., Crevenna, R.[2022]

Extracorporeal shockwave therapy (ESWT) is a well-tolerated treatment for various musculoskeletal conditions, including tendinopathies and nonunion fractures, with a low incidence of complications.

While complications are rare, there have been isolated reports of serious injuries, such as bone injury and Achilles tendon rupture, particularly in older adults receiving focused shockwave therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Shockwave Treatment for Management of Upper and Lower Extremity Musculoskeletal Conditions: A Narrative Review. Reilly, JM., Bluman, E., Tenforde, AS.[2019]

In a study of 42 patients with knee osteoarthritis, focused extracorporeal shockwave therapy (f-ESWT) was found to be more effective than radial extracorporeal shockwave therapy (r-ESWT) in reducing pain intensity, as measured by the visual analog scale (VAS), after 4 weeks of treatment.

Both therapies improved physical function, but f-ESWT showed greater improvements in pain, WOMAC scores, and the 6-minute walk test, indicating it may be a superior option for managing knee osteoarthritis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Focused Extracorporeal versus Radial Extracorporeal Shockwave Therapy for Knee Osteoarthritis-Randomized Controlled Study. Ko, NY., Chang, CN., Cheng, CH., et al.[2022]

Citations

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

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

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9199449/

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clinicaltrials.gov

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The evolving use of extracorporeal shock wave therapy ...

Researchers demonstrated the use of ESWT to reduce pain and promote healing in bone, tendon, ligament and fascia in patients with musculoskeletal disorders.