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Shockwave Therapy

Shockwave Therapy for Plantar Fasciitis

N/A
Waitlist Available
Led By Kristina Quirolgico, MD
Research Sponsored by Hospital for Special Surgery, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Minimum VAS pain of 40/100 (4/10; morning pain when taking first steps, pain after prolonged walking/standing)
Be older than 18 years old
Must not have
Systemic inflammatory disorders
Nerve entrapment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial sought to compare the effect of radial vs. focused extracorporeal shockwave therapy on pain in patients with chronic plantar fasciitis.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Shockwave therapies may cause temporary side effects such as bruising, swelling at the treatment site, pain during and after treatment sessions and possibly skin damage if not administered correctly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My pain level is at least 4 out of 10 when I walk or stand for a long time.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a condition that causes long-term inflammation in my body.
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I have a trapped nerve.
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I have had a tendon rupture.
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I have pain in both of my heels.
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I have not had a cortisone injection in the last 3 months.
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I have a bleeding disorder or I'm taking blood thinners.
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I have issues with my nerves or blood vessels.
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I have an ongoing infection in the area.
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I have a bone disorder in my legs.
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I have a heel bone fracture.
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I have had surgery on my foot before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Visual analog scale pain - after prolonged walking or standing
Visual analog scale pain - morning
Secondary study objectives
Foot and Ankle Outcome Score (FAOS)
PROMIS Physical Function computer adaptive test score
Treatment satisfaction

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: ControlActive Control1 Intervention
Patients in the control group will be treated using the home therapy protocol only.
Group II: Radial shockwave therapyActive Control3 Interventions
Patients will receive 4 sessions of radial shockwave therapy.
Group III: Focused shockwave therapyActive Control3 Interventions
Patients will receive 4 sessions of focused shockwave therapy.

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor
250 Previous Clinical Trials
61,222 Total Patients Enrolled
Kristina Quirolgico, MDPrincipal InvestigatorHospital for Special Surgery, New York

Media Library

Focused Shockwave Therapy (Shockwave Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04332471 — N/A
Heel pain Research Study Groups: Control, Radial shockwave therapy, Focused shockwave therapy
Heel pain Clinical Trial 2023: Focused Shockwave Therapy Highlights & Side Effects. Trial Name: NCT04332471 — N/A
Focused Shockwave Therapy (Shockwave Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04332471 — N/A
~2 spots leftby Jan 2025
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