Shockwave Therapy for Plantar Fasciitis

Overseen By Olivia Rau

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hospital for Special Surgery, New York

Must not be taking: Anti-coagulants

Disqualifiers: Foot surgery, Heel pain, Coagulopathies, Neurologic, others

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

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

114 Participants Needed

Trial Summary

What is the purpose of this trial?

Inflammation of the plantar fascia is known as plantar fasciitis and is commonly seen in active or overweight individuals. It can be treated via conservative or surgical therapies. Extracorporeal shockwave therapy has shown promise in the treatment of plantar fasciitis. Several studies have compared the effects of different types of extracorporeal shockwave therapy (radial and focused) with other forms of conservative treatment in patients with chronic plantar fasciitis. No study has yet compared the effect of radial vs. focused shockwave therapy on pain in this population.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using anti-coagulants (blood thinners).

What data supports the effectiveness of shockwave therapy for treating plantar fasciitis?

Research shows that both focused and radial shockwave therapies are effective in treating plantar fasciitis, with studies indicating improvements in foot function and pain relief. These therapies have been compared and found to provide similar benefits, making them viable options for managing this condition. ^{1 2 3 4 5}

How does shockwave therapy for plantar fasciitis differ from other treatments?

Shockwave therapy for plantar fasciitis is unique because it uses sound waves to stimulate healing in the foot, which can be done without anesthesia and is effective for chronic cases. It differs from other treatments by offering two types: focused shockwave therapy, which targets specific areas, and radial shockwave therapy, which covers a broader area. ^{1 2 3 6 7}

Research Team

Kristina Quirolgico, MD

Principal Investigator

Hospital for Special Surgery, New York

Eligibility Criteria

This trial is for English-speaking individuals with chronic plantar fasciitis, experiencing significant morning pain or discomfort after long periods of standing/walking. They should have had the condition for over 3 months and found other treatments ineffective. People with recent platelet-rich plasma injections, infections, rheumatologic or systemic inflammatory disorders, bone diseases in the lower extremity, coagulopathies, calcaneal fractures, nerve issues, tendon ruptures or previous foot surgery are excluded.

Inclusion Criteria

English-speaking

My pain level is at least 4 out of 10 when I walk or stand for a long time.

I have had chronic plantar fasciitis for over 3 months that hasn't improved with treatment.

Exclusion Criteria

I have a condition that causes long-term inflammation in my body.

I have a trapped nerve.

I have had a tendon rupture.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4 sessions of either radial or focused shockwave therapy

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 1 year

Treatment Details

Interventions

• Focused Shockwave Therapy
• Radial Shockwave Therapy

Trial Overview The study is testing two types of shockwave therapy—radial and focused—to see which one better reduces pain from chronic plantar fasciitis compared to home therapy. It's a randomized controlled trial (RCT), meaning participants will be randomly assigned to receive either radial shockwave therapy, focused shockwave therapy or continue with their home therapy regimen.

Participant Groups

Group I: Control Active Control 1 Intervention

Patients in the control group will be treated using the home therapy protocol only.

Group II: Radial shockwave therapy Active Control 3 Interventions

Patients will receive 4 sessions of radial shockwave therapy.

Group III: Focused shockwave therapy Active Control 3 Interventions

Patients will receive 4 sessions of focused shockwave therapy.

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

Findings from Research

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]

References

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

Comparison of radial versus focused extracorporeal shock waves in plantar fasciitis using functional measures. [2014]

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

Comparative effectiveness of focused shock wave therapy of different intensity levels and radial shock wave therapy for treating plantar fasciitis: a systematic review and network meta-analysis. [2022]

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

Similar Functional Gains Using Radial Versus Combined Shockwave Therapy in Management of Plantar Fasciitis. [2021]

4. Bulgaria pubmed.ncbi.nlm.nih.gov

Radial shock wave therapy for plantar fasciitis: a one year follow-up study. [2020]

5. 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]

6. France pubmed.ncbi.nlm.nih.gov

Cadaveric experiments to evaluate pressure wave generated by radial shockwave treatment of plantar fasciitis. [2018]

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

Radial extracorporeal shock wave therapy is safe and effective in the treatment of chronic recalcitrant plantar fasciitis: results of a confirmatory randomized placebo-controlled multicenter study. [2008]