Shockwave Therapy for Plantar Fasciitis

RR
JC
OR
Overseen ByOlivia Rau
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Hospital for Special Surgery, New York
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 explores two types of shockwave therapy to determine which is more effective for easing pain in individuals with stubborn plantar fasciitis (foot pain from inflammation). Participants will receive either radial shockwave therapy, focused shockwave therapy, or continue with home treatment. The trial seeks individuals who have had plantar fasciitis for over three months, have tried other treatments without success, and experience significant pain, especially in the morning. As an unphased trial, it offers participants the chance to explore innovative treatments for persistent pain relief.

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 prior data suggests that shockwave therapy is safe for treating plantar fasciitis?

Research shows that both focused and radial shockwave therapy are generally safe for treating plantar fasciitis. Studies have found that this therapy reduces pain and improves mobility.

For focused shockwave therapy, research indicates it is well-tolerated, with no major issues reported. One study found it effectively reduced the thickness of the plantar fascia (the tissue band on the bottom of the foot) and decreased pain over time.

Radial shockwave therapy also appears safe. Research shows positive results, with success rates between 34% and 88%. Studies noted no major problems, even after one year of follow-up.

Overall, both types of shockwave therapy are considered safe options for those dealing with plantar fasciitis.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about focused and radial shockwave therapies for plantar fasciitis because these treatments offer a non-invasive alternative to traditional options like physical therapy, orthotic devices, and corticosteroid injections. Both therapies use sound waves to stimulate healing in the affected heel area, potentially reducing pain and improving function without the need for medication or surgery. Focused shockwave therapy targets precise, deep tissue areas, while radial shockwave therapy covers a broader, more superficial area. This versatility allows for tailored treatment approaches depending on the patient's specific needs and response to therapy.

What evidence suggests that this trial's treatments could be effective for plantar fasciitis?

This trial will compare the effectiveness of focused shockwave therapy and radial shockwave therapy for treating plantar fasciitis. Studies have shown that extracorporeal shockwave therapy works well for this condition. Focused shockwave therapy, which participants in this trial may receive, can greatly reduce pain, with more than half of patients experiencing at least 60% less discomfort. Radial shockwave therapy, another treatment option in this trial, also shows good results, with success rates between 34% and 88%. Both types of shockwave therapy improve pain, movement, and quality of life for people with plantar fasciitis. Overall, research suggests that both focused and radial shockwave therapies are promising options for managing this condition.12467

Who Is on the Research Team?

KQ

Kristina Quirolgico, MD

Principal Investigator

Hospital for Special Surgery, New York

Are You a Good Fit for This Trial?

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.
See 11 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
3Treatment groups
Active Control
Group I: ControlActive Control1 Intervention
Group II: Radial shockwave therapyActive Control3 Interventions
Group III: Focused shockwave therapyActive Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials
257
Recruited
61,800+

Published Research Related to This Trial

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.
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]

Citations

Effectiveness of shockwave therapy in the treatment ...Conclusion: Shock wave therapy was effective for plantar fasciitis treatment according to the proposed protocol considering pain, function and quality of life.
Long Term Effectiveness of ESWT in Plantar Fasciitis ...The results indicate that the pain was significantly reduced after 12 weeks of ESWT; however, no significant differences were found between the ...
Effectiveness and tolerability of focal versus radial ...Long-term outcome of low- energy extracorporeal shock wave therapy for plantar fasciitis: comparative analysis according to ultrasonographic findings. Ann ...
Complications of extracorporeal shockwave therapy in ...Ten out of 20 (50%) studies using high-dose ESWT and two out of nine low-dose studies (22%) reported pain during treatment. Low-dose ESWT results in a reduced ...
Focused Extracorporeal Shock Wave Therapy Better Than ...Slightly more than one-half the patients treated with extracorporeal shock wave therapy had at least a 60% reduction in pain compared with just ...
Ultrasonography and clinical outcome comparison of ...At 4th week after treatment, the thickness of plantar fascia increased. Then it decreased gradually, but not to the baseline at 12th week. On the pain level ...
Shockwave Therapy for Plantar Fasciitis RCTExtracorporeal shockwave therapy has shown promise in the treatment of plantar fasciitis. Several studies have compared the effects of different types of ...
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