Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID03231150

Randomized Clinical Study to Evaluate Ultrasound Guided Injection Therapy Versus Topographic Injection Therapy for Plantar Fasciitis

Led by University of Pennsylvania · Updated on 2025-10-10

62

Participants Needed

1

Research Sites

19 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare two methods of corticosteroid injection for treating proximal plantar fasciitis, a condition causing heel and arch pain, especially when first stepping after rest. The study evaluates the effectiveness of ultrasound-guided injection versus anatomic topography-guided injection in relieving pain. Secondary goals include assessing foot-related quality of life and changes in plantar fascia thickness over time. Participants will be randomly assigned to receive either an anatomically guided injection or an ultrasound-guided injection. Both groups will receive injections containing bupivacaine, dexamethasone, and triamcinolone acetonide. The anatomical group will have the injection guided by palpation and a sham ultrasound device, while the ultrasound group will receive the injection with real ultrasound guidance in a radiology setting. Both approaches use a medial plantar approach and include preparation and dressing of the injection site. During the study, participants will have their pain assessed using a visual analog scale at baseline and at 3, 6, 9, and 12 months after injection. Foot function and quality of life will be evaluated using the Foot Function Index and Bristol Foot Score over the same time points. Ultrasound will also be used to measure plantar fascia thickness before and after treatment in the ultrasound group. The study includes double-blind randomization and aims to monitor safety and outcomes over a year of follow-up.

CONDITIONS

Brief Title

Plantar Fasciitis Randomized Clinical Control Trial

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pain on palpation along the proximal plantar fascia with or without radiographic evidence of a plantar calcaneal bone spur
  • 18 years of age or older
  • Male or non-pregnant female of any ethnicity or race
  • Active, former, or non-smoker
  • With or without peripheral vascular disease without lower extremity intermittent claudication or rest pain
  • With or without diabetes mellitus without polyneuropathy
  • With or without collagen vascular disease without lower extremity wound formation
Not Eligible

You will not qualify if you...

  • Known drug or alcohol dependence
  • Chronic pain syndrome or lumbosacral radiculitis
  • Neurological condition requiring analgesic, anti-seizure, or neuroleptic medications
  • Peripheral vascular disease with rest pain, intermittent claudication, or venous stasis ulceration
  • Calcaneal stress fracture or radiographic evidence of foreign body or tumor in affected heel
  • Pregnant females
  • Known allergy to any injection therapy components
  • Plantar fascia rupture or surgery within the past 5 years
  • Existing or prior osteomyelitis of the involved calcaneus
  • Unable to consent or currently participating in another clinical trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment session

Participants receive a single corticosteroid injection into the plantar heel, either guided by ultrasound or by anatomical landmarks, to treat plantar fasciitis.

1 injection visit (in-person)

Follow-up

Duration - 12 months

Participants attend follow-up visits to monitor pain relief and foot function, and to assess plantar fascia thickness using ultrasound over the course of one year.

Follow-up visits at 3, 6, 9, and 12 months (in-person)

Trial Site Locations

Total: 1 location

1

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

D

Donald S Malay, DPM

H

Hye R Kim, DPM

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

A new minimally invasive technique for treating plantar fasciosis using bipolar radiofrequency: a prospective analysis.

Lowell Weil, Jason P Glover, Lowell Scott Weil

https://pubmed.ncbi.nlm.nih.gov/19825686