Corticosteroid Injections for Plantar Fasciitis

Phase 1

Recruiting

Led By Michael A Jones, DPM

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 2, week 4, week 8, and week12

Summary

This trial suggests CSI+LA may offer short-term pain relief from plantar fasciitis, but has potential side effects and risks.

Who is the study for?

This trial is for men and women over 18 with chronic heel pain diagnosed as plantar fasciitis, lasting at least 6 weeks. It's not for pregnant individuals, those under 18, people with inflammatory arthritis or prior heel trauma/surgery, allergies to corticosteroids/anesthetics, previous heel injections, or diabetes.

What is being tested?

The study tests two treatments for plantar fasciitis: one group receives a corticosteroid injection (CSI) combined with local anesthetic (LA), while the other gets LA with saline. The goal is to compare their effectiveness in short-term pain relief.

What are the potential side effects?

Potential side effects of CSI include tissue damage around the heel, fat pad thinning beneath the skin, color changes on the skin surface and even risk of tearing the plantar fascia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 2, week 4, week 8, and week12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 2, week 4, week 8, and week12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2, week 4, week 8, and week12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Foot Function Index (FFI) scores

Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - first step pain

Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - heel tenderness

Secondary study objectives

Exit Survey Scores

Patient Exercise Diary Results

heel pressure threshold scores

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: corticosteroid injection/ local anesthetic (CSI/LA)Experimental Treatment1 Intervention

The PI will then administer the (CSI/LA) injection using an infracalcaneal needle peppering technique as follows: 1. The hypodermic needle is inserted using infracalcaneal injection approach. 2. The hypodermic needle is withdrawn while at the same depositing injectate 3. The hypodermic needle is redirected without emerging from the skin. The PI will perform steps 1-3 standardly 20-25 times.

Group II: local anesthetic (LA)/Saline injectionPlacebo Group1 Intervention

The PI will then administer the (LA/Saline) injection using an infracalcaneal needle peppering technique as follows: 1. The hypodermic needle is inserted using infracalcaneal injection approach. 2. The hypodermic needle is withdrawn while at the same depositing injectate 3. The hypodermic needle is redirected without emerging from the skin. The PI will perform steps 1-3 standardly 20-25 times.

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