Shockwave Therapy for Chronic Knee Pain

Recruiting at2 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Kessler Foundation

Must not be taking: Glucocorticoids, Bisphosphonates

Disqualifiers: Autoimmune diseases, Bilateral BMLs, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a non-invasive treatment using sound waves to help people with knee arthritis who have not improved with standard treatments. The goal is to see if this new method can reduce pain and improve knee function better than current care options. Wearable long-duration low-intensity ultrasound is an emerging non-invasive and non-narcotic therapy for the daily treatment of musculoskeletal pain.

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 data supports the idea that Shockwave Therapy for Chronic Knee Pain is an effective treatment?

The available research shows that Shockwave Therapy, specifically focused extracorporeal shockwave therapy (f-ESWT), is effective for treating chronic knee pain, particularly in knee osteoarthritis. One study found that patients who received f-ESWT experienced a greater reduction in pain and improved physical function compared to those who received radial shockwave therapy. For example, the pain score decreased by 4.5 points in the f-ESWT group compared to 2.6 points in the radial group. Additionally, both groups showed improvements in walking ability and knee movement, but the f-ESWT group had better results overall. This suggests that f-ESWT is a promising treatment for reducing pain and improving function in people with knee osteoarthritis. ^{1 2 3 4 5}

What safety data exists for shockwave therapy for chronic knee pain?

The safety data for extracorporeal shockwave therapy (ESWT) indicates that it is generally well-tolerated for musculoskeletal conditions, including knee osteoarthritis. Complications are rare, with only two reported cases of injury to bone and Achilles tendon rupture in older adults using focused shockwave therapy. Overall, studies suggest ESWT is a safe treatment option for knee pain. ^{2 4 6 7 8}

Is focused extracorporeal shockwave therapy a promising treatment for chronic knee pain?

Yes, focused extracorporeal shockwave therapy (f-ESWT) is a promising treatment for chronic knee pain. Studies show that it can significantly reduce pain and improve physical function in patients with knee osteoarthritis, making it more effective than other types of shockwave therapy. ^{1 2 4 5 9}

Research Team

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Focused Extracorporeal Shockwave Therapy (Other)

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.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 Intervention

Participants will receive the conventional treatment for bone marrow lesions, which includes avoidance of weight bearing and anti-inflammatory medications.

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

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

References

1. England 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of extracorporeal shockwave therapy for knee osteoarthritis: a randomized controlled trial. [2022]

3. United States 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. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Extracorporeal shockwave therapy for the treatment of knee osteoarthritis: a meta-analysis. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Focused Extracorporeal versus Radial Extracorporeal Shockwave Therapy for Knee Osteoarthritis-Randomized Controlled Study. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Successful application of focused extracorporeal shockwave therapy for plantar fasciitis in patients suffering from metastatic breast cancer. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of extracorporeal shock wave therapy in patients with knee osteoarthritis: A cohort study protocol. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Effect of Shockwave Treatment for Management of Upper and Lower Extremity Musculoskeletal Conditions: A Narrative Review. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

The effect of extracorporeal shock wave therapy on the treatment of moderate to severe knee osteoarthritis and cartilage lesion. [2022]