NCT04332471

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Jun 2020Mar 2027

First Submitted

Initial submission to the registry

March 11, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

April 28, 2026

Status Verified

January 1, 2026

Enrollment Period

6.8 years

First QC Date

March 11, 2020

Last Update Submit

April 23, 2026

Conditions

Plantar Fascitis

Outcome Measures

Primary Outcomes (2)

  • Visual analog scale pain - morning

    Morning pain. This will be assessed on a scale of 0-100, with a higher score representing more pain.

    Up to 1 year

  • Visual analog scale pain - after prolonged walking or standing

    Pain after prolonged walking or standing. This will be assessed on a scale of 0-100, with a higher score representing more pain.

    Up to 1 year

Secondary Outcomes (3)

  • PROMIS Physical Function computer adaptive test score

    Up to 1 year

  • Foot and Ankle Outcome Score (FAOS)

    Up to 1 year

  • Treatment satisfaction

    Up to 1 year

Study Arms (3)

Control

ACTIVE COMPARATOR

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

Other: Home therapy

Radial shockwave therapy

ACTIVE COMPARATOR

Patients will receive 4 sessions of radial shockwave therapy.

Procedure: Radial shockwave therapyDevice: Shockwave therapy deviceOther: Home therapy

Focused shockwave therapy

ACTIVE COMPARATOR

Patients will receive 4 sessions of focused shockwave therapy.

Procedure: Focused shockwave therapyDevice: Shockwave therapy deviceOther: Home therapy

Interventions

Radial shockwave therapyPROCEDURE

Target intensity will be within a range of 3.5-5.0 bar at maximum Hz, titrated up to patient tolerance within 100 pulses. Total of 3000 pulses.

Radial shockwave therapy
Focused shockwave therapyPROCEDURE

Target intensity will be within a range of 0.15-0.25 mJ/mm2 at maximum Hz, titrated up to patient tolerance within 100 pulses. Total of 3000 pulses.

Focused shockwave therapy
Shockwave therapy deviceDEVICE

The shockwave therapy device will be used to administer either radial or focused shockwave therapy.

Focused shockwave therapyRadial shockwave therapy
Home therapyOTHER

Stretching and ice massage

ControlFocused shockwave therapyRadial shockwave therapy

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients presenting with a clinical diagnosis of chronic plantar fasciitis (\>3 months) that has been recalcitrant to other treatments
  • Minimum VAS pain of 40/100 (4/10; morning pain when taking first steps, pain after prolonged walking/standing)
  • English-speaking

You may not qualify if:

  • Cortisone injection within the past 3 months
  • Platelet-rich plasma injection within the past 6 months
  • History of previous foot surgery
  • Bilateral heel pain
  • Coagulopathies or use of anti-coagulants
  • Local and systemic neurologic or vascular insufficiencies
  • Rheumatologic disorders
  • Systemic inflammatory disorders
  • Active or chronic infection in the area
  • Lower extremity bone disorders (e.g., Paget's disease, osteomyelitis)
  • Calcaneal fractures
  • Nerve entrapment
  • Ruptures in tendon
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

Home Infusion Therapy

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsHome Care ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Kristina Quirolgico, MD

    Hospital for Special Surgery, New York

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2020

First Posted

April 2, 2020

Study Start

June 1, 2020

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

April 28, 2026

Record last verified: 2026-01

Locations

US(1)