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Treatment of plantar fasciitis with radial shockwave therapy vs. focused shockwave therapy: a randomized controlled trial

IRB Number: 2019-1517

May 20, 2021

Institutional Review Board, Hospital for Special Surgery

The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

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Principal Investigator

Kristina Quirolgico, M.D.


Steve B. Behrens, MD
Sean Matsuwaka, MD   
Deirdre Rodericks, MD
Jennifer Cheng, PhD    


Inflammation of the plantar fascia is known as plantar fasciitis. Extracorporeal shockwave therapy is a non-invasive treatment that recently has shown promise in treatment of plantar fasciitis. There are two types - radial and focused shockwave therapy. These treatments have different mechanisms, with focused therapy creating deeper-penetrating, higher-energy shockwaves, while radial therapy produces more superficial shockwaves that can treat a wider area of pathology. In this study we will treat patients with plantar fasciitis for longer than 3 months with current conservative standard of care: calf and plantar fascia stretching as well as use of gel heel cups for 1 month. Patients who have no relief will then be randomized to get radial or focused shockwave therapy. Shockwave treatments will be done at the maximal point of tenderness on their heels once a week for 4 weeks (total of 4 treatments). The patients in each of the 3 groups will then take surveys to assess VAS pain, functional outcomes, complications, and satisfaction at 1 month, 3 months, 6 months, and 1 year. The goal of this study is to compare the effectiveness of current conservative treatment vs radial shockwave therapy vs focused shockwave therapy in alleviating patients' pain. A total of 104 patients will be enrolled.

Inclusion/Exclusion Criteria

Inclusion Criteria

1. Ages 18+
2. Clinical diagnosis of chronic plantar fasciitis (>3 months) that has not responded to other treatments
3. Minimum VAS pain of 40/100 (4/10) => morning pain when taking first steps, pain after prolonged walking/standing
4. English-speaking


Exclusion Criteria

1. Cortisone injection within the past 3 months
2. Platelet-rich plasma injection within the past 6 months
3. History of previous foot-related injury
4. Previous foot surgery
5. Bilateral heel pain
6. Coagulopathies or use of anti-coagulants
7. Local and systemic neurologic or vascular insufficiencies
8. Rheumatologic disorders
9. Systemic inflammatory disorders
10. Active or chronic infection in the area
11. Lower extremity bone disorders (e.g., Paget's, osteomyelitis)
12. Calcaneal fractures
13. Nerve entrapment
14. Ruptures in tendon
15. Non-English speaking

Contact Information

Kristina Quirolgico, MD

Jennifer Cheng

Kristen Santiago